Surgical versus conservative interventions for displaced intra-articular calcaneal fractures

  • Review
  • Intervention

Authors


Abstract

Background

Fractures of the calcaneus (heel bone) comprise up to 2% of all fractures. These fractures are mostly caused by a fall from a height, and are common in younger adults. Treatment can be surgical or non-surgical; however, there is clinical uncertainty over optimal management.

Objectives

To assess the effects of surgical compared with conservative treatment of displaced intra-articular calcaneal fractures in adults.

Search methods

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to July 2011), the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2011 Issue 3), MEDLINE (1948 to July 2011), EMBASE (1980 to 2011 Week 27), the WHO International Clinical Trials Registry Platform, Current Controlled Trials, and Orthopaedic Trauma Association annual meeting archives (1996 to 2011). Reference lists of retrieved articles were checked. No language restrictions were applied.

Selection criteria

Randomised and quasi-randomised controlled clinical studies comparing surgical versus conservative management for displaced intra-articular calcaneal fractures.

Data collection and analysis

Two review authors independently screened search results, selected studies, extracted data and assessed risk of bias. Primary outcomes were function (e.g. walking ability) and chronic pain. Risk ratios were calculated for dichotomous outcomes and mean differences for continuous outcomes. Missing standard deviations were calculated from P values.

Main results

Four trials were included (602 participants). Three trials were small single-centre trials, and the fourth a large multi-centre trial including 424 participants. All trials had methodological flaws, usually failure to conceal allocation and incomplete follow-up data, which put them at high risk of bias. Follow-up ranged from 1 to 15 years after treatment.

Data for functional outcomes, including walking ability, from three trials could not be pooled. The strongest evidence was from the multi-centre trial. This showed no statistically or clinically significant differences between the surgical and conservatively treated groups at three years follow-up in the ''validated disease-specific" score (0 to 100: perfect result; 424 participants; mean difference (MD) 4.30, 95% confidence interval (CI) -1.11 to 9.71; P = 0.12). There was no significant difference between the two groups in the risk of chronic pain at follow-up (19/40 versus 24/42; risk ratio (RR) 0.79, 95% CI 0.53 to 1.18; 2 trials). The multi-centre trial found no statistically or clinically significant difference between the two groups in health-related quality of life at three years follow-up (SF-36 (0 to 100: best outcome): MD 4.00, 95% CI -1.16 to 9.16; P = 0.13).

Two small trials provided some limited evidence of a tendency for a higher return to previous employment after surgery (27/34 versus 15/27; RR 1.45, 95% CI 0.75 to 2.81; I² = 55%; 2 trials). One small trial found no difference between the two groups in the ability to wear normal shoes, whereas another small trial found that surgery resulted in more people who were able to wear all shoes comfortably. There was a higher rate of major complications, such as surgical site infection, after surgery compared with conservative treatment (57/206 versus 42/218; RR 1.44, 95% CI 1.01 to 2.04; 1 trial). Conversely, significantly fewer surgical participants had subtalar arthrodeses due to the development of subtalar arthritis (7/206 versus 37/218; RR 0.20, 95% CI 0.09 to 0.44; 1 trial). There were no significant differences between the two groups in range of movement outcomes or radiological measurements (e.g. Bohler's angle).

Authors' conclusions

The bulk of the evidence in this review derives from one large multi-centre but inadequately reported trial conducted over 15 years ago. This found no significant differences between surgical or conservative treatment in functional ability and health related quality of life at three years after displaced intra-articular calcaneal fracture. Though it reported a greater risk of major complications after surgery, subtalar arthrodeses for the development of subtalar arthritis was significantly greater after conservative treatment.

Overall, there is insufficient high quality evidence relating to current practice to establish whether surgical or conservative treatment is better for adults with displaced intra-articular calcaneal fracture. Evidence from adequately powered randomised, multi-centre controlled trials, assessing patient-centred and clinically relevant outcomes is required. However, it would be prudent to reassess this need after an update of the review that incorporates new evidence from a currently ongoing multi-centre trial.

Résumé scientifique

Interventions chirurgicales versus conservatrices pour des fractures intra-articulaires du calcanéum avec déplacement

Contexte

Les fractures du calcanéum (os du talon) représentent jusqu'à 2 % de l’ensemble des fractures. Ces fractures sont provoquées par une chute depuis un lieu élevé et sont fréquentes chez les jeunes adultes. Le traitement peut être chirurgical ou non chirurgical, mais il existe une incertitude clinique quant à la prise en charge optimale.

Objectifs

Évaluer les effets d’un traitement chirurgical comparativement à un traitement conservateur des fractures intra-articulaires du calcanéum avec déplacement, chez les adultes.

Stratégie de recherche documentaire

Nous avons effectué des recherches dans le registre spécialisé du groupe Cochrane sur les traumatismes ostéo-articulaires et musculaires (jusqu’à juillet 2011), le registre Cochrane des essais contrôlés (CENTRAL) (The Cochrane Library, Numéro 3, 2011), MEDLINE (de 1948 à juillet 2011), EMBASE (de 1980 à la semaine 27 de 2011), le système d'enregistrement international des essais cliniques de l'OMS, les essais contrôlés en cours et dans les archives des conférences annuelles de l’Orthopaedic Trauma Association (de 1996 à 2011). Les références bibliographiques des articles que nous avons trouvés ont été vérifiées. Aucune restriction de langue n'a été appliquée.

Critères de sélection

Études cliniques randomisées et quasi-randomisées comparant une prise en charge chirurgicale versus une prise en charge conservatrice des fractures intra-articulaires du calcanéum avec déplacement.

Recueil et analyse des données

Deux auteurs de la revue ont passé au crible les résultats de la recherche, sélectionné des études, extrait les données et évalué les risques de biais de manière indépendante. Les principaux critères de jugement étaient la fonction (aptitude à la marche par exemple) et la douleur chronique. Les risques relatifs ont été calculés pour les résultats dichotomiques et les différences moyennes pour les résultats continus. Les écarts-types manquants ont été calculés à partir des valeurs de P.

Résultats principaux

Quatre essais ont été inclus (602 participants). Trois essais étaient de petits essais monocentriques et le quatrième, un grand essai multicentrique incluant 424 participants. Tous les essais étaient entachés de défauts méthodologiques, habituellement un échec de l’assignation secrète et des données de suivi incomplètes, ce qui les exposaient à un risque élevé de biais. La durée du suivi allait de 1 à 15 ans après traitement.

Les données concernant les résultats fonctionnels, notamment la capacité de marche, issues de trois essais n'ont pas pu être regroupées. Les preuves les plus solides provenaient de l'essai multicentrique. Celui-ci n’a montré aucune différence statistiquement ou cliniquement significative entre le groupe traité chirurgicalement et le groupe traité de manière conservatrice après trois ans de suivi, dans le score « validé spécifique à la maladie » (0 à 100 : résultat parfait ; 424 participants ; différence moyenne (DM) = 4,30, intervalle de confiance (IC) à 95 % de -1,11 à 9,71 ; P = 0,12). Aucune différence significative n’a été observée entre les deux groupes en ce qui concerne le risque de douleur chronique lors du suivi (19/40 versus 24/42 ; risque relatif (RR) = 0,79 ; IC à 95 % de 0,53 à 1,18 ; 2 essais). L’essai multicentrique n’a mis en évidence aucune différence statistiquement ou cliniquement significative entre les deux groupes en matière de qualité de vie liée à l’état de santé, après trois ans de suivi (Questionnaire SF-36 (0 à 100 : meilleur résultat) : DM = 4,00 ; IC à 95 % de -1,16 à 9,16 ; P = 0,13).

Deux petits essais ont apporté quelques preuves limitées d'une tendance à un plus grand nombre de reprises de l’activité professionnelle antérieure après un traitement chirurgical (27/34 contre 15/27 ; RR = 1,45, IC à 95 % de 0,75 à 2,81 ; I² = 55 % ; 2 essais). Un petit essai n'a révélé aucune différence entre les deux groupes en ce qui concerne la capacité à se chausser normalement tandis qu'un autre petit essai a constaté qu’avec le traitement chirurgical, un plus grand nombre de personnes étaient en mesure de porter confortablement toutes les chaussures. Le taux de complications majeures, telles que des infections du site opératoire, s'est avéré plus élevé après traitement chirurgical comparativement au traitement conservateur (57/206 versus 42/218 ; RR = 1,44, IC à 95 % de 1,01 à 2,04 ; 1 essai). En revanche, beaucoup moins de participants traités chirurgicalement ont eu une arthrodèse sous-talienne en raison de la survenue d’arthrose sous-talienne (7/206 contre 37/218 ; RR =0,20 ; IC à 95 % de 0,09 à 0,44 ; 1 essai). Aucune différence significative entre les deux groupes n’a été observée pour les résultats relatifs à l’amplitude du mouvement ou les mesures radiologiques (par exemple, l'angle de Böhler).

Conclusions des auteurs

L'essentiel des preuves, dans la présente revue, proviennent d’un grand essai multicentrique, mais dont le compte-rendu des résultats est incorrect et qui a été conduit il y a plus de 15 ans. Cet essai n’a pas trouvé de différence significative entre le traitement chirurgical et le traitement conservateur en ce qui concerne la capacité fonctionnelle et la qualité de vie liée à l’état de santé, trois ans après une fracture intra-articulaire du calcanéum avec déplacement. Bien qu'il ait rapporté un plus grand risque de complications majeures après un traitement chirurgical, le nombre d’arthrodèses sous-taliennes en raison de la survenue d’arthrose sous-talienne était significativement plus élevé après traitement conservateur.

Dans l'ensemble, il n'y a pas suffisamment de preuves de qualité élevée sur les pratiques actuelles pour pouvoir déterminer si le meilleur traitement est un traitement chirurgical ou conservateur pour les adultes présentant une fracture intra-articulaire du calcanéum avec déplacement. Des preuves issues d’essais contrôlés multicentriques, randomisés, dotés d’une puissance suffisante, évaluant des critères centrés sur le patient et cliniquement pertinents sont nécessaires. Cependant, il serait prudent de réévaluer ce besoin après une mise à jour de la revue dans laquelle seront intégrées de nouvelles preuves issues d’un essai multicentrique actuellement en cours.

摘要

手术与非手术治疗移位性关节内跟骨骨折

研究背景

跟骨骨折构成所有骨折的大约2%。这种骨折最容易发生于高处坠落之后,年轻人是高发群体。治疗可以采用手术或者非手术两种方案;然而,那种方案更好目前没有临床定论。

研究目的

我们要对比手术与非手术两种方案治疗移位性关节内骨折的效果。

检索策略

我们检索了Cochrane图书馆骨、关节、肌肉创伤组(the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register)(至2011年7月),Cochrane临床研究注册中心 the Cochrane Central Register of Controlled Trials(Cochrane图书馆,2011年3卷),MEDLINE (1948年至2011年7月),EMBASE (1980年至2011年7月),WHO国际临床试验注册平台(the WHO International Clinical Trials Registry Platform),今日临床对照研究(Current Controlled Trials),创伤骨科年会档案(Orthopaedic Trauma Association annual meeting archives)(1996年至2011年)。检索相关文献的参考文献。发表语言不限。

标准/纳入排除标准

所有对比手术与非手术方案治疗移位性关节内跟骨骨折的随机或半随机临床对照研究。

数据收集与分析

两位作者独立的梳理搜索结果,挑选符合纳入标准的研究,提取数据并对偏倚风险进行评估。 主要的结局指标为患肢功能(行走功能)和慢性疼痛。 用危险比(RR)来评价非连续变量资料结果,平均差(MD)来评价连续变量资料结果。 缺失的标准差(SD)根据P值计算。

主要结果

本研究共纳入了4个研究(602名患者)。 其中3个研究为小样本的单中心研究,第4个研究为大样本的多中心研究,纳入了424名患者。 所有的研究都有方法学的缺陷,通常是没有分配隐藏和随访资料不完整,这些都可能带来较高的偏倚风险。 随访时间为1至15年。

从其中的3个研究中未能合并出功能结局,例如行走能力。 主要的证据来源于第4个多中心研究。 这个研究显示在3年的随访当中手术组与非手术治疗组在特定疾病评分(''validated disease-specific" score),方面没有统计或者临床差异(MD=4.30,95%CI(-1.11,9.71),P=0.12)。 在慢性疼痛方面两组治疗方案也没有明显差异((19/40 对 24/42; RR=0.79, 95% CI(0.53,1.18); 2 个研究))。 这项多中心研究在3年随访期结束后也没有发现两种干预方法在生活质量评分上统计学或临床差异((MD=4.00,95%CI(-1.16,9.16),P=0.13))。

两个小样本的研究提供了有限的证据表明手术可能使患者更早的恢复工作((27/34 对15/27; 一个小样本的研究发现两种干预措施在随访期结束时穿的鞋子和平时没有什么差别,而另一个小样本研究报告手术可以使更多患者能够舒服地穿戴平时的鞋子。 手术与非手术组相比可以带来更高的并发症,如手术部位感染风险((57/206对42/218; 相应的,由于手术可以导致距下关节炎,手术患者再次行距下关节融合手术的风险也显著降低((7/206对37/218; RR= 0.20, 95% CI( 0.09,0.44); 1个研究))。 两组患者在关节功能评价和影像学评价(Bohler角)上也没有明显差异。

作者结论

本次研究的证据主要来源于一个15年前大样本多中心但是报道不充分的研究。 经过3年的随访,在患者的功能恢复、生活质量方面手术或保守治疗跟骨关节内移位性骨折没有明显差异。 尽管手术会带来一系列的并发症,但是保守治疗会使发生距下关节炎的风险明显升高,距下关节关节炎需要进一步的进行距下关节融合手术。

总之,需要进一步高质量的研究才能确定手术或者非手术对成人移位性关节内骨折哪一种效果更好。 需要充分随机的、多中心临床试验来评估这些治疗的效果。 当然,目前有一项多中心临床试验在研,当该研究完成并被纳入本系统综述的更新,上述需求可能需要重新评估。

翻译注解

翻译者:赵文涛,审校:李迅。本翻译由北京中医药大学循证医学中心组织和提供。

Plain language summary

Surgery or non-surgical treatment for broken heel bones

Fractures or breaks of the heel bone mostly involve a joint within the heel. These injuries can be difficult to treat and manage. This injury typically occurs in young adults after a fall from a height. Heel fractures are painful and cause significant disability because they prevent weight-bearing for many weeks after injury. These fractures restrict physical activity, delay return to work and usual activities, and can have other consequences, such as being unable to wear the same shoes as before injury.

Treatment of heel fractures can be broadly divided into surgical or non-surgical (conservative) management. Surgery involves a procedure where a plate and screws are inserted into the heel to stabilise the broken bones. This is usually followed by a period of non-weight bearing of six to eight weeks. Non-surgical treatment initially involves leg elevation, ice and plaster cast splints and then gradual introduction of non-weight bearing mobilisation for six to eight weeks. Currently, there is no consensus over which is the best management strategy for patients.

This review included four studies (602 participants) that have looked at the results of surgery compared with non-surgical treatment for people who have had a heel fracture. The strongest evidence comes from one large multi-centre Canadian trial that recruited 424 participants. The remaining studies were small. All four studies had weaknesses in their design, conduct and reporting.

Based mainly on the results from the largest study, the review found no strong evidence of differences between surgical and non-surgical treatment in functional ability, including walking, and quality of life, at three years after treatment. From two small studies, there is some evidence that participants having surgery were more likely to return to work more quickly. However, those having surgery were more likely to have a major complication such as surgical site infection after treatment. Conversely, those having surgery were less likely to have joint fusion surgery because they had developed arthritis later on.

The review concluded that there was currently insufficient evidence to say whether surgical or non-surgical treatment of heel fractures is best. Further good quality research is recommended.

Résumé simplifié

Traitement chirurgical ou non chirurgical des fractures du calcanéum

Les fractures ou ruptures du calcanéum concernent essentiellement une articulation à l’intérieur du talon. Ces blessures peuvent être difficiles à traiter et à prendre en charge. Cette blessure survient généralement chez de jeunes adultes après une chute d’un lieu élevé. Les fractures du calcanéum (talon) sont douloureuses et entraînent une invalidité importante, car elles interdisent tout appui pendant de nombreuses semaines après la blessure. Ces fractures restreignent l'activité physique, retardent le retour à la vie professionnelle et la reprise des activités habituelles et peuvent avoir d'autres conséquences, comme l’incapacité de porter les mêmes chaussures qu’avant la blessure.

Le traitement des fractures du calcanéum peut se diviser grossièrement en deux types de prises en charge : traitement chirurgical ou non chirurgical (conservateur). Le traitement chirurgical implique une intervention au cours de laquelle une plaque et des vis sont insérées dans le talon pour stabiliser les os fracturés. L’intervention est habituellement suivie d'une interdiction d’appui pendant une période de six à huit semaines. Le traitement non chirurgical consiste initialement à positionner la jambe en surélévation, à mettre en place des attelles plâtrées et appliquer des poches de glace, puis à introduire progressivement une mobilisation sans appui pendant six à huit semaines. Actuellement, il n'existe pas de consensus quant à la meilleure de ces stratégies de prise en charge des patients.

Cette revue comprenait quatre études (602 participants) ayant examiné les résultats d’un traitement chirurgical comparativement à un traitement non chirurgical chez des personnes présentant une fracture du calcanéum. Les preuves les plus solides proviennent d'un grand essai multicentrique canadien qui a recruté 424 participants. Les autres études étaient de petite taille. Les quatre études comportaient toutes des faiblesses quant à leur schéma, leur conduite et l’établissement des comptes-rendus.

En se fondant principalement sur les résultats de la plus grande des études, la revue n'a trouvé aucune preuve solide attestant de différences entre le traitement chirurgical et non chirurgical au plan de la capacité fonctionnelle, y compris en ce qui concerne la marche et la qualité de vie, trois ans après le traitement. Il ressort des deux petites études quelques preuves attestant que les participants traités par chirurgie avaient davantage tendance à reprendre leur activité professionnelle plus rapidement. Toutefois, ceux traités par chirurgie étaient plus susceptibles d'avoir une complication majeure, telle qu'une infection du site opératoire après le traitement. A l'inverse, ceux traités par chirurgie étaient moins susceptibles de subir une arthrodèse en raison d’arthrose survenue ultérieurement.

La revue a conclu qu’il n’y avait pas actuellement suffisamment de preuves pour déterminer si le meilleur traitement des fractures du calcanéum est chirurgical ou non chirurgical. Il est recommandé d'effectuer des recherches supplémentaires de bonne qualité.

Notes de traduction

Traduit par: French Cochrane Centre 5th February, 2013
Traduction financée par: Minist�re du Travail, de l'Emploi et de la Sant� Fran�ais

概要

手术与非手术治疗跟骨骨折

跟骨的骨折往往影响到周围的关节。这种损伤不容易处理。跟骨骨折最容易发生在年轻人这个群体,而且多发生于高处坠落之后。由于跟骨骨折后患者很多个星期下肢不能负重,所以跟骨骨折会给患者带来很多痛苦和显著的功能障碍。骨折可以限制患者的体育活动、延缓恢复工作和正常活动的时间,也可以有其他的影响,比如损伤前后不能穿同样的鞋子。

跟骨骨折治疗的方案大体可以分为手术治疗和非手术治疗两种。手术治疗指的是采用固定板和螺钉来固定破损的跟骨。而后往往需要6-8个星期的非负重休息。非手术治疗一般是是采用抬高患肢,冰敷和石膏固定,然后在以后的6-8个星期里逐渐开展一些非负重的功能锻炼。目前,医生们对采用那一种治疗方案更好并没有共识。

本综述纳入了四个研究(602名患者),对比了手术与非手术方案治疗跟骨骨折的效果。最重要的证据来自于一个加拿大的多中心研究共纳入了424名患者。其他的研究样本量偏小。所有的四个研究在实验设计、执行以及报道上都有缺陷。

在加拿大大样本研究的基础上,我们的综述没有发现手术与非手术治疗的效果的明显差异,比如三年后的行走功能、生活质量。从两个小样本研究看出,有些证据显示手术的患者可能可以更快的恢复工作。然而,手术的患者也可能更容易患上手术相关的感染。相反的,手术的患者也由于手术相关的关节炎而不太可能进行关节融合手术。

我们的综述得出结论,目前没有充足的证据证明手术或者非手术方案那种更好。需要进一步进行高质量的研究。

翻译注解

翻译者:赵文涛,审校:李迅。本翻译由北京中医药大学循证医学中心组织和提供。

Background

Description of the condition

Calcaneal or heel fractures are fractures of the calcaneus, also called the heel bone or os calcis. They comprise 2% of all fractures (Ibrahim 2007; Koval 2006). Most calcaneal fractures occur in younger working-age men. The economic impact of this injury to both the patient and society is considerable and is a consequence of extended hospital stay, cost of treatment, residual pain, time to mobilisation and delayed return to work (Schepers 2007). Studies suggest that people with these injuries can be incapacitated for up to three years and partially impaired for several years subsequently (Clarke 2007).

Heel bone fractures can be broadly divided into intra-articular (where the articular or joint surfaces of the calcaneus are disrupted) and extra-articular fractures (where the articular surfaces remain intact). Approximately three-quarters of calcaneal fractures are intra-articular (Ibrahim 2007). The majority of displaced intra-articular fractures involve the posterior facet, which is the major weight-bearing surface of the sub-talar (ankle bone) joint (Koval 2006).

Displaced intra-articular calcaneal fractures (DIACFs) are typically the result of high energy trauma, such as a fall or jump from a height. Patients present with a painful, swollen and deformed heel. Some patients may be unable to walk properly or at all. Bruising around the heel extending into the arch of the foot is suggestive of calcaneal fracture; blistering may also result as a consequence of significant swelling. Approximately 15% of all calcaneal fractures are open, where the fractured bone is exposed (Essex-Lopresti 1952), and between 5% and 10% are bilateral, thus involving both feet (Sanders 2000).

Description of the intervention

It is generally agreed that undisplaced extra-articular fractures should be managed conservatively, with a combination of rest, analgesia, compression, splinting and non weight-bearing for six to eight weeks (Clarke 2007). However the treatment of displaced intra-articular calcaneal fractures (DIACFs) is more problematic. Historically, DIACFs were also treated conservatively with a combination of rest with elevation, ice and immobilisation with plaster cast splintage, followed by physiotherapy and gradual mobilisation (Sanders 2000). However, this often led to delayed reconstruction of the malunited fracture, leaving patients with a painful and stiff foot which delayed or permanently prevented return to work and previous activities. Until the 1970s, operative treatment was technically challenging, and often led to postoperative infection, malunion, nonunion and amputation (McLaughlin 1963).

In the last 20 years, improvements in anaesthesia, antibiotic prophylaxis, the Arbeitsgemanschaft für Osteosynthesefragen/Association for the Study of Internal Fixation (AO/ASIF) principles of fixation, advances in materials and implants, and computed imaging have led to improvements in outcome after operative repair. This has popularised fixation of most fractures, including those of the calcaneus. Operative treatments for DIACF include reduction (repositioning of the displaced bone fragments) with percutaneous pin fixation, open reduction and internal fixation (ORIF) or primary arthrodesis (joint fusion). In percutaneous fixation, Kirschner-wires (K-wires) and pins are inserted through only minimal skin incisions. ORIF entails a skin incision through which the fracture fragments are visualised, realigned and then held in position by plate and screws. Subtalar arthrodesis (joint fusion) is generally used as a last resort and reserved for the most severe fractures or when non-union and prolonged joint pain predominate. Postoperative complications, such as surgical site infection and delayed wound healing, can occur after surgical stabilisation of calcaneal fractures. One study, based upon retrospective record review, reported that 25% of patients developed wound complications, with an increased risk observed in those with open fractures, diabetes and amongst smokers (Folk 1999).

How the intervention might work

Surgical fixation aims to restore, or at least improve, the normal anatomy of the heel bone and congruity of the subtalar joint. Accurate and rigid internal fixation of intra-articular fractures aims to give the best possible range of movement by allowing early motion and optimising joint mechanics. In doing so it aims to speed recovery and return to previous activities. This in turn should reduce long-term risk of developing symptomatic arthritis.

In the past some have advocated subtalar arthrodesis as the initial fracture treatment for all DIACFs (Harris 1946), because the severity of joint disruption was not retrievable and early fusion allowed more rapid return to function than a persistently painful and stiff malunited fracture. However, more recently this approach has been restricted to those with more severe injuries (Buch 1996; Sanders 1991).

Although advances in surgical techniques may have improved functional outcome for many patients, surgical fixation of these fractures is still technically challenging and the risks of surgical complications, such as surgical site infection (SSI), and of treatment failure remain.

Why it is important to do this review

A previous systematic review of the treatment of calcaneal fractures (Bridgman 1999) concluded that "even where there is some benefit of operative compared with non-operative treatment, it remains unclear whether the possible advantages of surgery are worth its risks". This conclusion was based on the evidence available from three small trials (O'Farrell 1993; Parmar 1993; Thordarson 1996), all of which were reported to be of poor methodological quality. The review by Bridgman 1999 referred to a large then-ongoing trial, which has since been published (Buckley 2002). It is thus important to update the review in the light of the new evidence, including data from Buckley 2002. Additionally, although modern surgical intervention has improved post-fracture outcome for many patients, there remains a lack of consensus on the use of surgery for the optimal management of calcaneal fractures.  

Objectives

To assess the effects (benefits and harms) of surgical versus conservative treatment of displaced intra-articular calcaneal fractures.

Methods

Criteria for considering studies for this review

Types of studies

Randomised and quasi-randomised (method of allocating participants to a treatment which is not strictly random; e.g. by date of birth, hospital record number, alternation) controlled clinical studies evaluating surgical versus conservative management for displaced intra-articular calcaneal fractures were eligible for inclusion.

Types of participants

Individuals aged over 14 years, considered as skeletally mature, with displaced intra-articular calcaneal fractures (DIACFs). Participants with unilateral or bilateral fractures were eligible for inclusion. We included all severities of fracture, both open and closed.

Types of interventions

Trials comparing surgical versus conservative treatment of DIACF were considered eligible for inclusion.

Surgical treatments
  1. Closed manipulation with percutaneous pin fixation

  2. Open reduction with internal fixation (ORIF) with or without bone graft

  3. Primary arthrodesis

Conservative treatments
  1. Ice and elevation

  2. Plaster cast immobilisation

  3. Early or delayed mobilisation

Rehabilitation, such as physiotherapy, is likely to be provided after definitive treatment, thus after either surgical or conservative treatment. Some trials may incorporate multiple interventions, such as surgery with mobilisation and physiotherapy. In such cases, patients having surgery were considered as the surgical treatment group and patients having non-surgical interventions were considered as the conservative treatment group.

Types of outcome measures

Preference was given to validated, patient-reported outcome measures of function and pain.

Primary outcomes
  • Function (e.g. walking ability). An example of an instrument commonly used to measure function (and pain) is the American Orthopaedic Foot and Ankle Society score (Kitaoka 1994)

  • Chronic pain (e.g. pain lasting beyond expected healing time, three months)

Secondary outcomes
  • Health-related quality of life (QoL)

  • Return to work and former activities, such as wearing usual footwear, returning to sporting activities, etc.

  • Postoperative complications (e.g. surgical site infection (SSI)) and other postoperative morbidity or other serious adverse event

  • Subsequent operation (after primary treatment)

  • Objective measures of impairment (e.g. range of ankle movement)

  • Time to union (bone healing)

  • Radiological measurements (e.g. Bohler’s angle and signs of osteoarthritis)

Search methods for identification of studies

Electronic searches

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to July 2011), the Cochrane Central Register of Controlled Trials (CENTRAL)(The Cochrane Library, 2011 Issue 3), MEDLINE (1948 to July 2011) and EMBASE (1980 to 2011 Week 27). To identify ongoing trials, we searched the WHO International Clinical Trials Registry Platform and Current Controlled Trials. We also searched the Orthopaedic Trauma Association annual meeting archives from 1996 to 2011. No restrictions were applied to the language of publication.

In MEDLINE, we combined subject-specific terms with the Cochrane Highly Sensitive Search Strategy for identifying randomised trials (sensitivity- and precision-maximizing version) (Lefebvre 2011). In EMBASE, subject-specific terms were combined with the relevant Scottish Intercollegiate Guidelines Network randomised controlled trial search strategy (SIGN). The search strategies for CENTRAL, MEDLINE and EMBASE are shown in Appendix 1.

Searching other resources

We checked the reference lists of relevant articles and contacted researchers involved with ongoing trials.

Data collection and analysis

Selection of studies

Both review authors independently examined the titles and abstracts of articles identified in the search as potentially relevant trials. From this initial assessment, we obtained full versions of all potentially relevant articles.

Data extraction and management

Both review authors independently extracted data using a piloted data extraction form. Disagreements were resolved by discussion.

Assessment of risk of bias in included studies

Both review authors independently assessed risk of bias using The Cochrane Collaboration's 'Risk of bias' tool (Higgins 2009). Assessors were not blinded to the authors or source institution. Appraisal criteria included: sequence generation for randomisation, concealment of allocation, blinding, incomplete outcome data, selective outcome reporting and other potential sources of bias (for example, an extreme imbalance in baseline patient characteristics).

Each of these factors was recorded as yes ('low' risk of bias), no ('high' risk) or unclear with a brief summary provided in table format (see the Characteristics of included studies). Where data were unclear, we contacted authors for clarification, where possible. After this process, each paper was graded as being at low, unclear or high risk of bias. Appendix 2 gives more information about the 'Risk of bias' tool.

Measures of treatment effect

For each outcome, summary estimates of treatment effect (with 95% confidence intervals (CI)) were calculated where possible. For dichotomous outcomes, the risk ratio (RR) was used when appropriate. For continuous outcomes, the mean difference (MD) was used when appropriate. Standardised mean differences were planned for pooling continuous outcomes using different measurement scales. Where possible, intention-to-treat data were used in the analysis.

Unit of analysis issues

We anticipated that unit of randomisation and analysis in the included trials would be the individual patient. This was confirmed by initial pilot screen of the published literature. However, bilateral calcaneal fractures are quite common and trials including patients with bilateral fractures may present results for fractures or limbs rather than individual patients. Where such unit of analysis issues arose and appropriate corrections had not been made, we considered presenting data for such trials where the disparity between the units of analysis and randomisation was small. However, all trials included in the final review analysed by individual rather than by fracture site.

Dealing with missing data

Where data were missing or unsuitable for analysis (for example where intention-to-treat analysis was not presented), we attempted to contact study authors for further information and data. Where data were missing to the extent that the study could not included in the meta-analysis and attempts to retrieve data had been exhausted, results were presented and discussed in the context of the findings. We calculated missing standard deviations from other available data such as standard errors, confidence intervals or P values. We calculated P values for proportions where these were not reported. We used available case analysis, whereby data were only included for those whom the result was known, thus denominators relate to those with data for the particular outcome in question. We did not impute missing values for the analyses (except for calculation of missing SDs and P values).

Assessment of heterogeneity

When deciding whether meta-analysis was appropriate, we assessed the clinical diversity across studies. This included assessment of the comparability of participant characteristics (such as age and type of fracture), interventions, co-interventions, and outcomes. Where two or more studies were deemed to be clinically homogenous, the pooled data were assessed for statistical heterogeneity using RevMan. Heterogeneity was assessed by visual inspection of the forest plot (analysis) along with the test for heterogeneity and the I² statistic (Higgins 2003).

Assessment of reporting biases

Where sufficient trials and data were available, we were to attempt to assess publication bias by preparing a funnel plot. Our searches for trials listed in clinical trial registers and trial protocols should help to avoid publication bias. Study authors were contacted in an attempt to establish a full data set or obtain reasons for the non-reporting of certain outcomes. This was not possible for some studies because of the length of time since publication, difficulty in tracing original data and failure to trace authors.

Data synthesis

Quantitative data were entered into RevMan and analysed using Cochrane MetaView. For each comparison, summary estimates of treatment effect together with 95% confidence intervals (CIs) were calculated for individual outcomes. For dichotomous outcomes, risk ratios (RRs) were calculated. For continuous outcomes, mean differences (MDs) or, where more appropriate, standardised mean differences (SMDs) were calculated. Initially we used the fixed-effect model. We also used the random-effects model in the event of unexplained heterogeneity.

Where possible, time to return to work and time to bone healing were analysed as survival (time to event) outcomes, using the appropriate analytical method (as described in the Cochrane Handbook for Systematic Reviews of Interventions). Where it was not appropriate to pool data, results were presented using a narrative approach and in table format.

Subgroup analysis and investigation of heterogeneity

In our investigation of heterogeneity we planned to consider aspects of clinical and methodological diversity. Considerations of clinical diversity were to include assessment of differences in study location and setting, participant characteristics including co-morbidities, characteristics of the trial interventions and of other care provided. For methodological diversity, this included assessment of the randomisation process, study quality (explicitly in terms of risk of bias), outcome measurement and analytical method.

We intended to analyse studies according to differences in surgery or conservative management. We did not anticipate any specific subgroup analyses, except for where there may be marked differences in surgical approaches, or specific regimens of rehabilitation or physiotherapy. If suitable data were available, we intended to conduct a subgroup analysis by severity of fracture and test whether subgroups were statistically significantly different from one another (Altman 2003). However, this was not undertaken due to the lack of clarity of description about fracture severity on all participants in included studies.

Sensitivity analysis

We intended to conduct sensitivity analyses by examining various aspects of trial and review methodology, including the effects of missing data, and including trials at high or unclear risk of bias, such as selection bias arising from the lack of allocation concealment, and trials only reported in conference abstracts.

Results

Description of studies

See: Characteristics of included studies; Characteristics of excluded studies; Characteristics of ongoing studies.

Results of the search

Both review authors independently read 305 titles and abstracts. Where discrepancies arose, the full paper was obtained for review. We identified 40 study reports for full assessment.

A total of four trials were included with data published across multiple (n = 20) publications (Buckley 2002; Chrintz 1993; Parmar 1993; Thordarson 1996). Nineteen study reports were excluded and one trial was placed in ongoing studies (see the Characteristics of ongoing studies). A study flowchart is presented in Figure 1.

Figure 1.

Study flow diagram.

Included studies

Data from the four included trials were published in a total of 20 conference abstracts and publications. The trials in the review were published between 1993 and 2002 although one trial recruited participants between 1977 and 1979 (Chrintz 1993). Parmar 1993 recruited patients between 1985 and 1992. The largest trial (Buckley 2002) recruited 426 participants between 1991 and 1997. Thordarson 1996 did not report on the timing of recruitment. All trials randomised by the individual rather than by fracture.

Studies were conducted in Canada (Buckley 2002), Denmark (Chrintz 1993), UK (Parmar 1993) and the USA (Thordarson 1996). Three trials were single centre studies (Chrintz 1993; Parmar 1993; Thordarson 1996) and one was a multi-centre trial (Buckley 2002). Overall, 602 participants were randomised to either surgery or conservative treatment of displaced intra-articular fracture and follow-up data were available for 443 (74%) participants. Three studies reported sample age and sex characteristics, either for those recruited (Buckley 2002) or for those followed up after treatment (Parmar 1993; Thordarson 1996). Overall, the age of participants ranged from 15 to 79 years, with estimates of mean age ranging from 35 years (Thordarson 1996) to 48 years (Parmar 1993). A total of 450 males and 56 females were included, reflecting the higher proportion of calcaneal injury in males (89% versus 11%).

The four studies used different methods of surgery (Buckley 2002: plate, screw or wire fixation; Chrintz 1993: Steinmann pin; Parmar 1993: K-wires; Thordarson 1996: plate fixation). There were also differences in the conservative and post-surgical treatment (e.g. Parmar 1993 used plaster cast mobilisation after surgical fixation; Thordarson 1996 prescribed early mobilisation), including timing of commencing weight-bearing (see the Characteristics of included studies).

The trials varied in timing of follow-up. Outcome data were reported at one to two years after treatment by three studies (Chrintz 1993; Parmar 1993; Thordarson 1996). Buckley 2002 reported follow-up data for two to eight years, with a mean follow-up of three years. Parmar 1993 also reported 15 year outcomes (Ibrahim 2007); however, this was for a limited subset of 33% of the original randomised cohort.

Excluded studies

Details of the 19 excluded studies are presented in the Characteristics of excluded studies. Of these, seven were review articles and nine were non-randomised controlled trials. Of these, one study (O'Farrell 1993) was an uncontrolled clinical study whereby allocation was based upon consultant treatment preference in a sequential series of participants; this study was included within previous systematic reviews (Bridgman 2002; Gougoulias 2009). Two excluded studies, which were solely reported as registrations in the UK-NRR archive were either not completed or no further details were obtained.

Risk of bias in included studies

Overall, all trials had methodological flaws that put them at either unclear or high risk of bias for at least one domain (see Figure 2 and Figure 3). A full description of risk of bias assessment for individual studies is also provided in the Characteristics of included studies.

Figure 2.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Figure 3.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Allocation

Parmar 1993, which used quasi-randomisation methods with allocation to treatment group by year of birth, was judged at high risk of selection bias. Chrintz 1993 was reported in two conference abstracts as being a 'randomized trial' but with no description of sequence generation or allocation concealment. Thordarson 1996 used sealed unmarked envelopes although no details were provided about sequence generation.

The large multi-centre Canadian trial (Buckley 2002) employed a more rigorous methodology, whereby random numbers were generated by a central administration site; these random number assignments were sent to recruiting study centres. This study described using a 'pre-randomized design' approach to minimise open discussion of uncertainty.

Blinding

Given the nature of the intervention, it was not appropriate to assess blinding of participants or treatment providers. However, it was appropriate to assess blinding of outcome assessors. Two trials (Chrintz 1993; Parmar 1993) were graded at high risk of bias and the other two trials (Buckley 2002; Thordarson 1996) at unclear risk. Buckley 2002 administered a standardised questionnaire to assess quality of life and disease-specific symptoms, but clinical judgement about quality of assessment of fracture reduction was conducted by the main investigator who had undertaken 73% of all surgical procedures.

Incomplete outcome data

All four trials were at high risk of bias from incomplete outcome data. This was mainly due to attrition bias from a loss to follow-up or post-randomisation exclusions. Incomplete reporting of data, such as providing percentages only in the main report of Parmar 1993, was another source of bias.

Buckley 2002 had a high attrition rate (27%). Although an intention-to-treat analysis was described (using 'complete study group' data), the derivation of the missing data was not clear. Additionally, participants who went on to have a subtalar arthrodesis for osteoarthritis (7 surgical group patients and 37 conservative group patients) were reported as having been excluded from the analysis). Chrintz 1993 was inadequately reported but also had a 24% loss (16/68) to follow-up. The description of participant flow in Parmar 1993 was unclear, with a high attrition (24/80 = 30%) at two years follow-up (an earlier Cochrane review (Bridgman 2002) reported that these 24 participants were excluded because they were followed up for less than one year) and an even higher attrition at 15 years follow-up, with outcome data being available for 26 participants only. Thordarson 1996 lost four (13%) of 30 randomised participants by 15 month follow-up. Additionally, only 11/30 (37%) participants attended for follow-up clinical examination with an imbalance between the two groups (8 versus 3).

Selective reporting

Two trials were at high risk of selective reporting because data for only one outcome were reported (Chrintz 1993) or because clinical outcomes were only reported for a subset of participants at follow-up (Thordarson 1996). The trial by Parmar 1993 excluded participants followed up for less than one year (24/80, 30%). For Buckley 2002, there was no apparent evidence of selective reporting, although the authors subsequently reported outcomes for selected participant subgroups.

Other potential sources of bias

Buckley 2002 was extensively published (nine publications) and although there appeared to be no differences in the main outcomes between treatment groups, subsequent publications found statistically significant findings within participant subgroups.

Effects of interventions

Data in the main report of Parmar 1993 were presented as whole percentages; some of which did not yield whole numbers upon calculation of the numerators for dichotomous data. In these cases we have rounded-up where the first decimal point is equal to or above 0.5.

Primary outcomes

Function e.g. walking ability

Three trials (Buckley 2002; Parmar 1993; Thordarson 1996) reported data for functional outcomes although based on different outcome measures. Chrintz 1993 stated that there were no differences between treatment groups in terms of functional outcomes but data values were not reported.

The measures used to capture function included: composite functional or gait scores, ability or distance walked without pain or difficulty, and other walking-related outcomes. The results are described below and presented in Analysis 1.1 (Figure 4) and Analysis 1.2.

Figure 4.

Forest plot of comparison: Function (e.g. walking ability)

Higher scores indicate improved function, except for FFI where higher score indicates greater impairment (score reversed). For Buckley 2002, a higher composite VAS score is assumed to indicate greater improvement.

Buckley 2002 used a 'validated disease-specific' VAS scale comprising 12 patient-completed items for pain, physical function, difficulty walking, limp and overall result from heel fracture. This scale also incorporated items for completion by the surgeon and an independent assessor (three items each). The overall score produced ranges from 0 to 100, where higher scores indicated improved outcome. The trial found no statistically significant differences between the two groups in the mean VAS scores (424 participants; MD 4.30, 95% CI -1.11 to 9.71; P = 0.12). Values for the standard deviations were calculated from the reported P value (P = 0.13). These data, which were presented for the 'complete study group', are assumed to relate to participant follow-up at a mean of three years after treatment (Buckley 2002).

A subsequent publication from Buckley 2002 selected seven questions from the full VAS scale and reported these as 'gait satisfaction' scores on a subset of 319 participants, stratified by various patient characteristics (e.g. age, sex, workers compensation status), with two to eight year follow-up (O'Brien 2004). However, O'Brien 2004 did not report mean gait satisfaction scores for the whole sample or by treatment group.

Thordarson 1996 developed a composite functional outcome questionnaire based upon an early version of the AOFAS instrument. This questionnaire includes domains of pain, daily activity, shoe wear, walking, exercise and work. Scores range from 0 (worst result) to 100 (best result). Mean functional scores were significantly higher 15 months after surgery (15 participants) compared with conservative treatment (11 participants): mean 86.1 versus 55.0; MD 31.10, 95% CI 17.08 to 45.12; P < 0.0001; see Analysis 1.1).

The 15 year follow-up (Ibrahim 2007) of a limited subset of 26 participants from Parmar 1993 presented data for the AOFAS hindfoot scale (0 to 100), Foot Function Index questionnaire (0 to 100: higher scores indicate greater impairment) and a composite Calcaneal Fracture Scoring system (0 to 100: higher scores indicating greater improvement). There were no statistically significant differences between surgical (n = 15) and conservative participants (n = 11) with respect to any of these outcome measures (see Analysis 1.1).

Parmar 1993 found no significant differences between the two groups at two years in the proportion of participants with no walking difficulty (7/25 versus 6/31; RR 1.45, 95% CI 0.56 to 3.76); ability to walk unlimited distance (11/25 versus 16/31; RR 0.85, 95% CI 0.49 to 1.49); or walking without a limp (18/25 versus 23/31; RR 0.97, 95% CI 0.70 to 1.34) (see Analysis 1.2).

Chronic pain

Chrintz 1993 reported without presenting data that there was no difference in pain between treatment groups. Pain was measured within composite functional or quality of life scales in the other three trials (Buckley 2002; Parmar 1993; Thordarson 1996). Pooled pain data reported in two trials (Parmar 1993; Thordarson 1996) for chronic pain (i.e. not minimal/infrequent pain) presented in Analysis 1.3 (Figure 5) showed no statistically significant difference between the two groups (19/40 versus 24/42; RR 0.79, 95% CI 0.53 to 1.18; I² = 44%). While Parmar 1993 presented percentages data for site and pattern of pain, the outcome definition and denominators used are unclear. Approximately half of the people had pain while walking on uneven or any surface in Thordarson 1996 (8/15 (53%) surgery versus 6/11(55%) conservative); three conservative group participants had pain when active and one had 'constant and bothersome' pain. The 15 year follow-up (Ibrahim 2007) of Parmar 1993 found different trends but no statistically significant differences between the two groups in the mean pain components within three composite functional scores (see Analysis 1.4).

Figure 5.

Forest plot of comparison: Chronic pain.

The risk ratio indicates risk of developing chronic pain after treatment.

Secondary outcomes  

Health-related quality of life (QoL)

Only one trial reported health-related quality of life data whereby the Short-Form-36 (SF-36) questionnaire was used at one and two years after treatment (Buckley 2002). Based upon follow-up data from 424 participants, there was no statistically or clinically significant difference between the two treatment groups respectively (MD 4.00, 95% CI -1.16 to 9.16; see Analysis 1.5; P = 0.13). Values for the standard deviations were calculated from the reported P value (P = 0.13). These data were manipulated by study authors in an attempt to identify differences by subgroups: SF-36 scores were dichotomised as above or below the sample mean and odds ratios were reported by age bands, sex, Bohler's angle, displacement classification, workload and involvement of injury. Given that sample sizes for these subgroup analyses were not reported and the high risk of multiple statistical testing, these data have not been presented in this review.

Return to work and former activities (ability to wear footwear, participate in sport, etc)
Return to work and other activities

The main report of Buckley 2002 did not present specific data on return to work. In a separate publication, Tufescu 2001 presented data on prediction of return to work; this was from a single surgeon who had participated in the wider study. These data were not used in this review. Chrintz 1993 reported, without presenting data, that there were no differences between the two groups in working ability, working capacity or leisure activity,

Data on return to work as before injury were pooled from two studies (Parmar 1993; Thordarson 1996) (see Analysis 1.6). The data for Parmar 1993 applied to the 35 men who were in work before their injury. A greater proportion of surgical participants returned to the same job compared with those having conservative treatment although this was not statistically significant and the data were heterogeneous (27/34 versus 15/27; RR 1.45; 95% CI 0.75 to 2.81; I² = 55%). The difference between the two groups was less for those returning to any employment (32/34 versus 22/27; RR 1.14; 95% CI 0.94 to 1.37) which included lighter and part time work. Seven of the remainder (2/34 versus 5/27) were unemployed and one in the conservative treatment group of Thordarson 1996 had severely impaired work capacity and was probably unemployed. At 15 years follow-up of Parmar 1993, there was no significant difference between the two groups in the work component of the Calcaneal Fracture Scale score (MD -0.60, 95% CI -8.27 to 7.07; see Analysis 1.7).

In Parmar 1993, a smaller proportion of surgical group participants returned to their previous recreation level (16/25 versus 23/31; RR 0.86, 95% CI 0.60 to 1.24; see Analysis 1.8). Thordarson 1996 found a greater proportion of surgical group participants had no limitations in their daily or recreational activities (13/15 versus 5/11; RR 1.91, 95% CI 0.97 to 3.75; see Analysis 1.8). Neither of these results were statistically significant. One conservatively treated participant in Thordarson 1996 had a severe limitation of activity.

Ability to wear usual shoes

Data for ability to wear usual shoes were available for two studies (Parmar 1993; Thordarson 1996) (see Analysis 1.9). These were not pooled given clearly statistical heterogeneity, which also may reflect differences in outcome measures. Parmar 1993 found no difference between the two groups in the ability to wear normal shoes (18/25 versus 22/31; RR 1.01, 95% CI 0.73 to 1.41). All participants of Thordarson 1996 were able to wear most shoes comfortably, although significantly more participants in the surgical group reported being able to wear all shoes comfortably (13/15 versus 4/11; RR 2.38, 95% CI 1.06 to 5.34).

Postoperative complications, other postoperative morbidity or serious adverse event

Three trials reported postoperative and other complications after treatment (Buckley 2002; Parmar 1993; Thordarson 1996) (see Table 1). Data from Buckley 2002 were reported over different publications: Howard 2003 found significantly more participants with major complications in the surgical group (57/206 versus 42/218; RR 1.44, 95% CI 1.01 to 2.04; see Analysis 1.10). These complications included late arthrodesis, thromboemboli, superficial and deep wound infections, malposition of fixation and compartment syndrome (see Table 1).

Table 1. Postoperative and other complications
  1. na = not applicable.
    *Non-operative complications included: secondary late arthrodesis, thromboembolism, compartment syndrome and lateral ostectomies. Operative complications included: superficial and deep infections, malposition of fixation, thromboembolism, compartment syndrome and late deep infection.

StudyOutcome

No. / Sample size (%)

Surgical

No. / Sample size (%)

Conservative

Buckley 2002Superficial SSI36/206 (17%)na
 Deep SSI11/206 (5%)na
(Howard 2003)Major complications*57/206 (28%)42/218 (19%)
 Superficial infections36/206 (17%)na
Parmar 1993Sural nerve symptoms8/25 (30%)6/31 (20%)
 Hypoaesthesia on clinical examination00
Thordarson 1996Superficial infection1/15 (7%)na

Parmar 1993 found no statistically significant difference between the two groups in sural nerve symptoms at one year follow-up (8/25 versus 6/31; RR 1.65, 95% CI 0.66 to 4.14; see Analysis 1.10). Notably, none of these 14 participants were found to have sural nerve hypoaesthesia when examined clinically.

Thordarson 1996 reported the only complication was a superficial site infection in surgical treatment group (1/15 (6.7%)).

Two studies (Chrintz 1993; Parmar 1993) reported on valgus deformity of the heel at follow-up. Chrintz 1993 reported without numerical data that this was found only in "conservatively treated patients". Three participants in each group of Parmar 1993 had valgus deformity (3/25 versus 3/31; RR 1.24, 95% CI 0.27 to 5.62; see Analysis 1.10).

Subsequent operation

Only Buckley 2002 reported data on reoperation or subsequent operation. In the surgical arm, two out of 206 participants (1%) required reoperation for hardware removal because screws had penetrated the posterior facet of the subtalar joint. Of those initially entered to the study, significantly fewer participants in the surgical arm went on to have subtalar arthrodeses for the development of subtalar arthritis (7/206 versus 37/218; RR 0.20, 95% CI 0.09 to 0.44; see Analysis 1.11). These patients were excluded from the final analysis. Additionally, the authors referred to subtalar arthrodeses to treat severe persistent pain within two years but these data were unavailable (Buckley 2002).

Range of movement (ROM)

Three trials (Chrintz 1993; Parmar 1993; Thordarson 1996) reported on range of movement but Chrintz 1993 stated only that there was no difference between the two groups in the "movement of the joints".

Parmar 1993 found no statistically significant differences at two year follow-up between the two groups in the numbers with normal ankle movement (19/25 versus 21/31; RR 1.12, 95% CI 0.81 to 1.56), normal subtalar movement (5/25 versus 4/31; RR 1.55, 95% CI 0.46 to 5.17) and those with more that 50% of the subtalar movement of the opposite side (13/25 versus 19/31; RR 0.85, 95% CI 0.53 to 1.36) (see Analysis 1.12). Two participants of the surgical group had no subtalar movement versus none in the conservative treatment group.

Thordarson 1996 found no significant difference in the mean subtalar range of motion (20º versus 17º) in the subset of 11 participants (8 surgery versus 3 conservative) who underwent physical examination. Ankle range of motion was recorded as normal or mildly restricted in these 11 patients and no differences were observed in ankle/hindfoot stability (data values not reported).

Time to union (bone healing)

None of the trials reported data on time to bone union. Thordarson 1996 reported that all fractures had healed in both treatment groups at follow-up.

Radiological measurements

All four trials recorded radiological measurements, including Bohler's angle, residual displacement of posterior facet and radiographic signs of subtalar arthrosis. These data are presented in Table 2. Data for radiological signs of subtalar arthritis presented in Analysis 1.13 show no difference between the two groups at either 80 weeks follow-up (Chrintz 1993) or 15 years follow-up (Parmar 1993).

Table 2. Radiological measurements
  1. nr = not reported
    ns = not statistically significant
    * Statistical test refers to pre-post change in surgical participants.
    ** Publication states Bohler's angle data available on 375 participants but not reported by group and unclear whether values relate to pre or post-treatment.
    § P values calculated in RevMan

StudyOutcomeSample size or No/Sample size (%)
(Surgical)
Score (SD)
(Surgical)
Sample size or No/Sample size (%)
(Conservative)
Score (SD)
(Conservative)
P value
Chrintz 1993Radiographic signs of subtalar arthrosis (%)12/26 (46%)-12/26 (46%)-1.00§
Parmar 1993 reported in Ibrahim 2007

Bohler's angle (mean) post-injury

Mean (SD)

67.7o (7.4)913.8o (11.2)nr
Ibrahim 2007

Bohler's angle (mean), 15 years

Mean (SD)

1516.9o (7.9)1110.4o (9.4)0.07
 

Calcaneal height (mm; mean) post-injury

Mean (SD)

636.2 (4.0)938.1 (4.0)nr
 

Calcaneal height (mm, mean), 15 years

Mean (SD)

1538.2 (4.1)1137.2 (4.7)0.57
 

Osteoarthritis of subtalar joint

(%) Moderate/severe grade

14/15 (93%)-10/11 (91%)-0.82§
Thordarson 1996

Bohler's angle, pre-treatment

Mean (SD)

1511o (nr)159o (nr) 
 

Bohler's angle , post-treatment

Mean (SD)

826o (nr)38o (nr)0.001*
 Residual displacement of posterior facet, mm. (Mean (SD)81.1 (nr)34.7 (nr)nr
Buckley 2002

Bohler's angle

Mean (SD)**

?1.3o (nr)?1.9o (nr)0.77

Buckley 2002 reported mean Bohler's angle values; however, it was unclear whether these values were measured pre- or post-treatment. Subgroup data for quality of fracture reduction (anatomic reduction, step-off of < 2 mm, comminuted reduction) were reported by mean VAS score in the operative group only. Another publication for this trial, reporting interim data for 88 participants, found no differences in Bohler's angle between treatment groups.

Chrintz 1993 found no differences in proportion with radiographic signs of subtalar arthrosis (12/26 versus 12/26) at median of 80 weeks follow-up. The authors stated that the degree of dislocation and Bohler's angle were significantly improved after surgical treatment; however, values were not reported.

Thordarson 1996 reported radiological results for a subgroup of 11 patients. They found a statistically significant improvement in the Bohler's angle in surgical participants between baseline and post-treatment (mean angle improved from 11º to 26º postoperatively; P = 0.001), compared with a decrease from 9º to 8º in those treated conservatively (P value not reported). Although mean residual displacement of the posterior facet values were reported, it was unclear at what time point radiographs were assessed (or whether on the subgroup of 11 participants assessed by an independent examiner at follow-up).

Radiological outcome data were only available for the 15 year follow-up of Parmar 1993. At 15 years after treatment, authors reported a trend to better Bohler's angle after surgery compared with conservative treatment (16.9º versus 10.4º; P = 0.07). No statistically significant differences were found between the two groups in calcaneal height (mean 38.2 mm versus 38.2 mm respectively; P = 0.57) nor in those with a moderate or severe grade of subtalar arthritis (14/15 versus 10/11; RR 1.03, 95% CI 0.82 to 1.29) (see Analysis 1.13).

Discussion

The findings of this review, based on four studies involving 602 participants, found no robust evidence of improved functional or clinical outcomes in adults managed with surgery or conservative treatment for displaced intra-articular calcaneal fractures. To date, only one large multi-centre study has compared surgery with conservative treatment; this moderate quality Canadian trial recruited 424 participants and found no difference between clinical and patient-reported outcomes. Other smaller poor quality studies demonstrated a trend for improved outcomes after surgery but this, drawing from the results of the large trial, will be at the expense of a higher risk of postoperative complications.

Summary of main results

Four trials comparing surgical with conservative interventions for displaced intra-articular calcaneal fractures were included in the review. Overall, the trials were small with intermediate follow-up ranging from one to two years after treatment. Chrintz 1993 was incompletely reported in conference abstracts. Long-term follow-up at 15 years after treatment was reported by Parmar 1993. However, this trial reported late outcomes on a small subset (33%) of the original randomised cohort, also used different questionnaires at follow-up from earlier timepoints (Parmar 1993). These data should be interpreted with caution.

The largest trial (424 participants) found no difference in functional outcomes (composite functional score including daily activity, walking an other items) between treatment groups (plate or wire fixation versus conservative treatment) (Buckley 2002). The small study by Thordarson 1996 (30 participants), reported improved walking ability and distance walked after plate fixation and early mobilisation compared to conservative treatment. For the two remaining studies, using K-wires and plaster cast mobilisation (Parmar 1993) or Steinmann pin fixation (Chrintz 1993), there were no significant differences in functional outcomes between surgical and conservative treatment.

Data were pooled for two outcomes: chronic pain and return to work. Data from two small studies showed no difference in the risk of developing chronic pain after treatment. Pain is an important outcome as it will impact upon return to work and overall satisfaction with clinical treatment. Although a trend was observed whereby a greater proportion of surgical patients returned to the same work as before injury compared to conservative treatment, this was not statistically significant. These studies were small (total 61 participants) and for one study (Parmar 1993), data were only reported for employed men rather than the full sample. Similarly there were no differences in the proportion of participants returning to any type of work. Although used inconsistently across the studies, return to work is an important outcome as it probably represents successful treatment from a functional perspective.

There is often a poor correlation between radiological and clinical outcomes but patient-centred outcomes (function, pain and return to work) are more important than radiological results. One trial attempted to address satisfaction using a composite VAS scoring system; however, the scale was interpreted differently in separate publications: e.g. full VAS scale (Buckley 2002) versus a subset of seven gait items from the full VAS scale, later referred to as the 'Gait Satisfaction' scale (O'Brien 2004). The largest trial by Buckley 2002 found no differences in health-related quality of life at follow-up after surgery compared with conservative treatment.

Another important patient-reported outcome is ability to wear the same shoes as before injury. No differences were found in wearing of same footwear as before injury, although in the small study (26 participants) by Thordarson 1996, a greater proportion of surgical participants could wear all shoes comfortably compared with after conservative treatment.

There was good evidence to suggest a higher rate of major complications after surgery compared to conservative treatment, with a 44% increased risk observed in surgical participants (Buckley 2002). Surgical site infections were the most common postoperative complication, with up to 17% developing either a superficial or deep SSI. Only one study assessed reoperation or subsequent operation. Buckley 2002 reported that a greater proportion of conservative participants went on to have subtalar arthrodeses for subtalar arthritis. However, these patients were incorrectly excluded from the analyses. Of the three studies reporting range of movement, no significant differences were found in degree of movement in the ankle or subtalar joint at follow-up (data not pooled).

Although all four trials reported radiological outcomes, variation in timing and type of assessment (e.g. measurement of Bohler's angle, anatomical reduction, signs of subtalar arthrodesis, degree of residual displacement) meant it was not possible to pool data. None of the studies reported statistically significant differences between radiological outcomes after surgery compared with conservative treatment.

Overall completeness and applicability of evidence

Of the 602 participants randomised to treatment, outcome data were available for 443 (74%) participants. Losses to follow-up were relatively low for studies conducting follow-up within two years of treatment although this varied by outcome. Few studies achieved high rates of return for clinical examination.

The aim of surgical management for displaced intra-articular fractures is anatomical reduction, stable fixation and early joint mobilisation (Ibrahim 2007). Given the timeline of the conducted studies, it is very likely that surgical technique may have changed over time. The earliest trial was conducted over 40 years ago (participants recruited from 1977 to 1979; Chrintz 1993) and the last participant recruited was in 1997 (Buckley 2002), over 15 years ago. Two studies used similar surgical procedures: open reduction and internal fixation with plates and screws, using a lateral approach (Buckley 2002; Thordarson 1996). Surgical technique was well described and also standardised within the multi-centre Canadian trial (Buckley 2002). However, one surgeon conducted 73% of all procedures within this study. These authors also reported subsets of data across multiple publications, one of which found that when workers compensation cases were excluded from the sample, analysis suggested that outcomes were improved after surgery in particular subgroups: e.g. young men, aged 20 to 29 years, women, those with a lower Bohler's angle or comminuted fracture preoperatively. However, these benefits may be at the expense of higher complication rates.

As with other surgical procedures, there may be a relationship between volume of surgery conducted and outcome. It would be expected, as noted in an online commentary to the Buckley 2002 paper (Sangeorzan 2002), that higher volume surgeons might have better surgical results, but even so Buckley 2002 only reported benefits of surgery in specific groups of patients within multiple subgroup analysis.

Quality of the evidence

Overall the quality (and quantity) of the evidence was poor. Three trials were small with overall sample sizes of less than 80 participants; data were only available from two of these. Particular methodological issues related to randomisation, inadequate concealment of allocation (Parmar 1993 was quasi-randomised), lack of intention-to-treat analyses and lack of blinding amongst outcome assessors.

Bias associated with incomplete outcome data, reflecting a large loss to follow-up or post-randomisation exclusions, was a major problem. In general, data were not fully reported, relevant outcomes were not measured or were often misinterpreted (e.g. health-related quality of life was referred to as 'patient satisfaction' in Buckley 2002). Additionally, straightforward presentation of primary outcome values (e.g. numerators and denominators, SDs) was lacking. For Buckley 2002, subgroup analyses were conducted and presented across multiple publications, resulting in differing sample sizes, times to follow-up, and reanalysis of primary outcomes. Authors were contacted to identify variance data for key primary outcomes but unfortunately these were unavailable.

Potential biases in the review process

The search strategy was comprehensive and we identified two abstracts that had not been retrieved by previous systematic reviews (Chrintz 1993). For our analyses, we did not pool estimates for data where there was evidence of clinical heterogeneity or risk of attrition bias. Unavaoidable bias may have arisen from our interpretation of trial methods and imputation of incompletely reported results (such as percentages in Parmar 1993); however, none of the analyses contradict the findings in the trial reports.

Agreements and disagreements with other studies or reviews

The findings from our review concur with findings from previous reviews. The original Cochrane review concluded there was scant trial-based evidence for the effectiveness of surgical treatment of calcaneal fractures and the possible complications of surgery (Bridgman 2002). We excluded one non-randomised study (O'Farrell 1993) that was included in the previous review. At that time, findings from the large Canadian trial were anticipated (Buckley 2002). In addition to data from Buckley 2002, our review identified two additional abstracts (Chrintz 1993) that have not been included in other reviews (Bridgman 2002; Gougoulias 2009). We await data from the recently closed UK multi-centre study (UK heel fracture trial).

Authors' conclusions

Implications for practice

Although uncommon, calcaneal fractures typically occur in younger adults, often of working age, and recovery is prolonged with considerable associated disability and delay in return to work or enforced change of occupation. There is clinical controversy over whether displaced intra-articular fractures should be treated surgically. The evidence from this updated systematic review, largely driven by one large multi-centre trial of moderate quality, suggests there is little difference between surgical and conservative treatment in terms of long-term function and quality of life. Based on data from two small poor quality trials, patients may be more likely to return to the same job as they had pre-injury after surgery. However, there is a greater risk of major complications after surgery; with the exception of subtalar arthrodeses for the development of subtalar arthritis, which favoured surgery. Overall, there is insufficient high quality evidence relating to current practice to establish whether surgical or conservative treatment is better for adults with displaced intra-articular calcaneal fracture.

Implications for research

It is possible that surgical management of displaced intra-articular calcaneal fracture may offer improved function and quicker return to work, but the evidence from published trials is insufficient to confirm or refute this hypothesis. The shortcomings of the present evidence base include small study bias, selection bias, performance bias, detection bias, and attrition bias. Additionally, reporting of the methods and results in the included trials did not meet best contemporary standards, nor current standards (CONSORT statement).

Further good quality research is clearly justified. There is one UK multi-centre study that has recently closed (UK heel fracture trial; 150 participants). Results from this study are expected in 2013. A Dutch multi-centre trial was discontinued in January 2012 because of difficulties with hospital and participant recruitment (Schepers 2012). Despite conducting a national survey to estimate incidence of heel fracture in order to accurately estimate patient throughput, the Dutch research group found that recruitment was much lower than expected with some hospitals preferring surgery over conservative treatment (personal communication; July 2012). This shows the challenge of implementing a clinical trial to evaluate the effectiveness and cost-effectiveness of alternative treatment strategies when a particular intervention(s) becomes widely accepted and ingrained within clinical practice. It would thus be prudent to assess the need for further trials, and what form they should take, after an update of this review that incorporates new evidence from the current UK heel fracture trial.

Given the often poor correlation between radiological and clinical outcomes, key patient-centred outcomes should be measured in future studies: e.g. validated scales to capture function, quality of life, patient satisfaction, return to work and complications of treatment. These should be captured in the short, medium and long term after treatment (e.g. immediately after injury, one year, five years). A key requirement of future studies is the simple presentation of key descriptive data for primary outcomes to allow data pooling (mean, standard deviation or median, inter-quartile range). Clear reporting of number of events by time to follow-up would also allow calculation of risk and rate ratios.

Acknowledgements

The authors would like to thank Helen Handoll, Nigel Hanchard, Mario Lenza, John McKinley and Janet Wale for their hard work in editing and reviewing the protocol and review. We would like to thank Joanne Elliott and Lesley Gillespie for developing the search strategies, and Lindsey Elstub and Amy Kavanagh for editorial support.

We would like to thank Dr Santosh Baliga for his help with the protocol.

Data and analyses

Download statistical data

Comparison 1. Surgery versus conservative management
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Function (including walking ability)3 Mean Difference (IV, Random, 95% CI)Totals not selected
1.1 Composite VAS score (0-100) at 3 years1 Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]
1.2 AOFAS score (0-100) at 1 year1 Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]
1.3 AOFAS score (0-100) at 15 years1 Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]
1.4 FFI score (0-100) at 15 years1 Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]
1.5 Calcaneal Function Score (0-100) at 15 years1 Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]
2 Walking ability at a minimum of 1 year1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
2.1 No walking difficulty (on all surfaces)1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
2.2 Walk unlimited distance1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
2.3 No limp1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
3 Chronic pain282Risk Ratio (M-H, Fixed, 95% CI)0.79 [0.53, 1.18]
4 Pain sub-scores of various functional scores (at 15 years)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
4.1 AOFAS score1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
4.2 FFI score1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
4.3 Calcaneal fracture score1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
5 SF-36 results at 1 or 2 years1424Mean Difference (IV, Fixed, 95% CI)4.0 [-1.16, 9.16]
6 Employment2 Risk Ratio (M-H, Random, 95% CI)Subtotals only
6.1 Return to same work261Risk Ratio (M-H, Random, 95% CI)1.45 [0.75, 2.81]
6.2 Return to any work261Risk Ratio (M-H, Random, 95% CI)1.14 [0.94, 1.37]
7 Work subscore of the Calcaneal fracture score (at 15 years)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
8 Recreational and daily activities2 Risk Ratio (M-H, Random, 95% CI)Totals not selected
8.1 Return to previous recreation level1 Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]
8.2 No limitations in daily or recreational activities1 Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]
9 Able to wear same shoes2 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
9.1 Able to wear normal shoes1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
9.2 Able to wear all shoes comfortably1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
10 Complications2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
10.1 Major complications1424Risk Ratio (M-H, Fixed, 95% CI)1.44 [1.01, 2.04]
10.2 Sural nerve symptoms156Risk Ratio (M-H, Fixed, 95% CI)1.65 [0.66, 4.14]
10.3 Valgus deformity156Risk Ratio (M-H, Fixed, 95% CI)1.24 [0.27, 5.62]
11 Arthrodesis (fusion) for post-traumatic arthritis1424Risk Ratio (M-H, Fixed, 95% CI)0.20 [0.09, 0.44]
12 Range of motion (objective impairment)1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
12.1 Normal ankle movement1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
12.2 Normal subtalar movement1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
12.3 > 50% subtalar movement of the opposite side1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
13 Osteoarthritis of subtalar joint (radiological signs)2 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
13.1 At median 80 weeks (1.5 years)1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
13.2 Moderate or severe arthritic grading at 15 years1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 1.1.

Comparison 1 Surgery versus conservative management, Outcome 1 Function (including walking ability).

Analysis 1.2.

Comparison 1 Surgery versus conservative management, Outcome 2 Walking ability at a minimum of 1 year.

Analysis 1.3.

Comparison 1 Surgery versus conservative management, Outcome 3 Chronic pain.

Analysis 1.4.

Comparison 1 Surgery versus conservative management, Outcome 4 Pain sub-scores of various functional scores (at 15 years).

Analysis 1.5.

Comparison 1 Surgery versus conservative management, Outcome 5 SF-36 results at 1 or 2 years.

Analysis 1.6.

Comparison 1 Surgery versus conservative management, Outcome 6 Employment.

Analysis 1.7.

Comparison 1 Surgery versus conservative management, Outcome 7 Work subscore of the Calcaneal fracture score (at 15 years).

Analysis 1.8.

Comparison 1 Surgery versus conservative management, Outcome 8 Recreational and daily activities.

Analysis 1.9.

Comparison 1 Surgery versus conservative management, Outcome 9 Able to wear same shoes.

Analysis 1.10.

Comparison 1 Surgery versus conservative management, Outcome 10 Complications.

Analysis 1.11.

Comparison 1 Surgery versus conservative management, Outcome 11 Arthrodesis (fusion) for post-traumatic arthritis.

Analysis 1.12.

Comparison 1 Surgery versus conservative management, Outcome 12 Range of motion (objective impairment).

Analysis 1.13.

Comparison 1 Surgery versus conservative management, Outcome 13 Osteoarthritis of subtalar joint (radiological signs).

Appendices

Appendix 1. Search strategies

The Cochrane Library (Wiley Online Library interface)

#1 MeSH descriptor Calcaneus explode all trees (95)
#2 MeSH descriptor Subtalar Joint (17)
#3 (#1 OR #2) (109)
#4 MeSH descriptor Fractures, Bone explode all trees (3129)
#5 (#3 AND #4) (39)
#6 (calcan* near/2 fracture*):ti,ab (46)
#7 (calcis near/2 fracture*):ti,ab (1)
#8 (#6 OR #7) (47)
#9 (#5 OR #8) (62)

MEDLINE (Ovid interface)

1.  Calcaneus/ (4930)
2.  Subtalar Joint/ (844)
3.  or/1-2 (5566)
4.  exp Fractures, Bone/ (122426)
5.  and/3-4 (1697)
6.  ((calcan$ or calcis) adj5 fracture$).tw. (1385)
7. or/5-6 (1991)
8.  randomized controlled trial.pt. (311155)
9.  controlled clinical trial.pt. (82831)
10. randomized.ab. (217312)
11. placebo.ab. (126412)
12. clinical trials as topic.sh. (155333)
13.  randomly.ab. (157067)
14.  trial.ti. (93004)
15.  or/8-14 (722471)
16.  exp animals/ not humans.sh. (3614789)
17.  15 not 16 (666825)
18.  7 and 17 (68)

EMBASE (Ovid interface)

1.     Calcaneus Fracture/ (1189)
2.     Subtalar Joint/ (1285)
3.     Intraarticular Fracture/ or Joint Fracture/ (1106)
4.     and/2-3 (41)
5.     ((calcan$ or calcis) adj5 fracture$).tw. (1666)
6.     or/1,4-5 (1992)
7.     Clinical trial/ (810400)
8.     Randomized controlled trial/ (282042)
9.     Randomization/ (53175)
10.   Single blind procedure/ (13680)
11.   Double blind procedure/ (99051)
12.   Crossover procedure/ (29993)
13.   Placebo/ (180511)
14.   Randomi?ed controlled trial$.tw. (61130)
15.   RCT.tw. (7099)
16.   Random allocation.tw. (1025)
17.   Randomly allocated.tw. (15063)
18.   Allocated randomly.tw. (1674)
19.   (allocated adj2 random).tw. (682)
20.   Single blind$.tw. (10785)
21.   Double blind$.tw. (115798)
22.   ((treble or triple) adj blind$).tw. (237)
23.   Placebo$.tw. (155955)
24.   Prospective study/ (165114)
25.   or/7-24 (1119553)
26.   Case study/ (12455)
27.   Case report.tw. (202029)
28.   Abstract report/ or letter/ (782726)
29.   or/26-28 (993346)
30.   25 not 29 (1086632)
31.   limit 30 to human (990368)
32.   and/6,31 (127)

Appendix 2. Assessment of risk of bias

Each of the following aspects were recorded as yes, no or unclear.

Sequence generation

Was the allocation sequence adequately generated: e.g. coin toss, random number tables, computer generated, other?

Allocation concealment

Was allocation adequately concealed in a way that would not allow both the investigators and the participants to know or influence the intervention group before an eligible participant is entered into the study: e.g. central randomisation, or sequentially numbered, opaque, sealed envelopes?

Incomplete outcome data

Were incomplete outcome data adequately addressed? Incomplete outcome data essentially include: attrition, exclusions and missing data. If any withdrawals occurred, were they described and reported by treatment group with reasons given? Whether or not there were clear explanations for withdrawals and dropouts in treatment groups was recorded. An example of an adequate method to address incomplete outcome data is the use of intention-to-treat analysis (ITT).

Selective outcome reporting

Are reports of the study free from suggestion of selective outcome reporting? This was interpreted as no evidence that statistically non-significant results might have been selectively withheld from publication: e.g. selective under reporting of data, or selective reporting of a subset of data.

Other sources of bias

Was the study apparently free of other problems that could put it at a high risk of bias: e.g. baseline imbalance, or the use of an insensitive instrument to measure outcomes?

Blinding

Details of blinding participants, personnel (surgeons) and outcome assessors were assessed. This was recorded as: yes, no or not possible, or unclear.

Quality assessment/internal validity

Quality assessment criteria were categorised as low, unclear or high risk of bias according to the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2009).

Contributions of authors

The review was conceived by AGS. The review was undertaken by JB and AGS. JB is the guarantor of the review. Both authors have contributed to the writing and revision of the review.

Declarations of interest

None known.

Sources of support

Internal sources

  • University of Aberdeen, UK.

  • University of Warwick, UK.

    Warwick Clinical Trials Unit

External sources

  • No sources of support supplied

Differences between protocol and review

1. There was a change in authorship.
2. An additional secondary outcome was added: Objective measures of impairment (e.g. range of ankle movement).

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Buckley 2002

MethodsSetting: initially 7 centres (14 surgeons) in Canada recruited but data from only 4 (6 surgeons) included as only these complied with the requirement of a minimum of 20 participants followed up for at least two years from each of participating surgeon; recruited from April 1991 to December 1997
Participants

Sample size: n = 512 registered; n = 424 enrolled in study (471 fractures)
Conservative: n = 206 (249 fractures)
Surgical: n = 218 (262 fractures)
Age (mean): 40 years (SD 11; range 15 to 68 years); surgical group mean 41 years; conservative group mean 39 years

Sex (M/F): 381/43

Workers compensation: 157/424 (37%) work-related injury

Inclusion criteria: intra-articular fracture, displaced > 2 mm on CT scan.

Exclusion criteria: medical contraindication to surgery; previous calcaneal injury; coexistent foot injury; head injury; injury that had occurred more than 14 days before presentation.

Interventions

Surgery: Open reduction and internal fixation (ORIF) involving extended lateral approach, use of plate, screw or wire fixation. Autografing left to surgeon discretion.

Conservative: Ice, elevation, rest.

Physiotherapy started after 6 weeks for all participants.

Outcomes

Follow-up: 2 to 4 weeks, 6, 12, 26, 52 weeks and 2 (minimum) to 8 years (maximum).

Quality of life (SF-36), disease-specific scale (VAS) (primary outcomes); Bohler's angle, postoperative complications, treatment failure/subtalar arthrodesis.

Notes

Follow-up: description unclear. States that 64 participants lost to follow-up were subsequently tracked and no complications developed. Incomplete reporting of main outcomes, no SD values reported (Buckley 2002). Sample size varies across different papers.

SF-36 and VAS data were provided for the 'complete study group' - but it is not clear how these were derived.

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low riskRandom number tables used after eligible for entry into study. Random numbers generated at the site of the principal investigator.
Allocation concealment (selection bias)Low riskCentral administrative site sent random number assignments to study centres.
Blinding (performance bias and detection bias)
All outcomes
Unclear riskOutcome assessment by postal questionnaire (primary outcome). Assessment of CT scans to assess quality of reduction conducted by lead author.
Incomplete outcome data (attrition bias)
All outcomes
High risk

Follow-up: 309/424 (73%) followed up for minimum of 2 years, maximum of 8 years (mean 3 years). Response rate to questionnaire not clearly reported. A later publication (O'Brien 2004) states that 319 participants completed the RCT at 2 to 8 years and reports different SF-36 values from the main paper (Buckley 2002).

Exclusion of data from 3 centres. The derivation of the data for the primary outcomes so that it is from the 'complete study group' is not shown.

Selective reporting (reporting bias)Unclear riskStates that intention-to-treat analysis was conducted. However, 44 cases (44/424 (10%)) who went on to have subtalar fusion were excluded from analyses.
Other biasUnclear risk

Of the 206 surgical procedures, 73% were conducted by lead author. Quality of life values often referred to as patient satisfaction. The SF-36 has no items to record 'satisfaction'. The visual analogue scale (VAS) for satisfaction was not defined within the paper, unclear whether higher values indicate better outcome (refers to earlier publication Hildebrand 1996).

Data reported across multiple abstracts and publications with subgroup analyses conducted.

Chrintz 1993

MethodsSetting: Copenhagen area, Denmark. Single centre. Participants recruited from 1977 to 1979.
Participants

Sample size = 68 fulfilled criteria
Conservative = 35 (26 assessed at median 80 weeks)
Surgical = 33 (26 assessed at median 80 weeks)
Age: not reported

Sex (M/F): not reported

Inclusion criteria: only unilateral fractures included.

Exclusion criteria: no previous calcaneus fracture.

Interventions

Surgery: reduction and fixation with a Steinmann pin through calcaneus and talus followed by a PTB ((patella tendon bearing) bandage for 12 weeks.

Conservative: PTB (patella tendon bearing) bandage for 12 weeks.

Outcomes

Follow-up: 6, 12 and a median of 80 weeks.

Pain, working capacity, activity in leisure time, working ability, tenderness on palpation or movement of the joints, duration of hospitalisation. Radiographic assessment of subtalar arthrosis. However, data for only one of these outcomes was reported: radiography outcome at a median of 80 weeks after treatment.

NotesTwo abstract reports of 'randomized trial'. Followed up for median of 80 weeks (1.5 years). Brief description given only ("no differences in all outcomes") - actual values only reported for radiographic data for subtalar arthrosis.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNo details provided in abstract. Abstract states: "In 1977-79, all patients with dislocated intraarticular fractures of calcaneus in the Copenhagen area were asked to participate in a randomized trial."
Allocation concealment (selection bias)Unclear riskNo details provided in abstract.
Blinding (performance bias and detection bias)
All outcomes
High riskNo detail reported about blinding of outcome assessors.
Incomplete outcome data (attrition bias)
All outcomes
High riskOutcome data reported for 52/68 (76%) followed-up at 80 weeks.
Selective reporting (reporting bias)High riskData on long-term outcomes not reported except for radiographic findings. Described as 'no difference in all outcomes'. No protocol available.
Other biasHigh riskPaper not published in full, conference abstract reports only.

Parmar 1993

MethodsSetting: UK, single centre. Participants recruited from 1985 and 1992.
Participants

Sample size = 179 referred. 105 had displaced intra-articular fractures, of which 25 could not be randomised although no reasons specified.
Randomised: n = 80. No explanation about discrepancy in 24 missing participants as sample drops from 80 to 56 at follow-up. (A previous review reports these participants were excluded because follow-up was less than one year; Bridgman 2002.)

Surgical: n = 25
Conservative: n = 31
Age (mean): surgical 48.8 years (range 20 to 79); conservative 48.3 years (range 20 to 72)

Sex (M/F ratio): surgical 6.8:1 (21/4) ; conservative: 5.3:1 (27/4). (ratios calculated by review authors).

Inclusion criteria: All participants had x-ray and CT scan preoperatively; displaced intra-articular fractures entered into trial.

Exclusion criteria: undisplaced and extra-articular fractures were treated conservatively, bilateral fractures and those who could not be randomised (no reasons given).

Interventions

Surgery: Open lateral reduction and Kirschner wire fixation of the posterior subtalar joint. Postoperative immobilisation in a plaster cast for 6 weeks.

Conservative: Closed mobilisation of the hindfoot. Elevation and ice for 5 to 7 days, with movement encouraged as pain allowed, non-weight bearing for 6 to 8 weeks.

Rehabilitation: all participants in both groups remained non-weight-bearing for 6 to 8 weeks, then gradual weight-bearing started.

Outcomes

Follow-up: 12 and 24 months (main 1993 paper); mean follow-up 23 months (surgical follow-up: mean 25.3 months; conservative: 21.6 months); later publication of 15 year outcomes (Ibrahim 2007) on subset of 26/56 responding survivors (46%).

Pain, use of analgesia, site/pattern of pain, sural nerve symptoms, walking difficulty, employment, recreation level, shoe wear, heel width, recovery plateau reached, compensation pending, no or mild problems.

At 15 years: multiple outcomes including AOFAS Hindfoot scale, Calcaneal Fracture Scoring system and Foot Function Index

NotesData in Parmar 1993 also reported for undisplaced fractures. Data difficult to interpret for some outcomes at one-year, partly because data presented as percentages.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)High riskQuasi-randomised by year of birth, with odd years entering the operative group and even years the conservative group.
Allocation concealment (selection bias)High riskAllocation predictable if year of birth known.
Blinding (performance bias and detection bias)
All outcomes
High riskBlinding not performed. No details provided about blinding of outcome assessors at 1 to 2 years. Independent assessors conducted 15 year follow-up.
Incomplete outcome data (attrition bias)
All outcomes
High risk

Lack of detail about numbers randomised (n = 80) and data reported at 2 years (n = 56). Previous review contacted authors and were informed that 24 participants were excluded because follow-up was less than 1 year (30%).

Results presented as whole percentages - these often do not correspond to whole numbers, indicating either errors in the calculation of percentages or different denominators.

Later publication of 15 year outcomes (Ibrahim 2007) on subset of 26/56 (46%) responding survivors (26/80, 33%). Also used different questionnaires at follow-up compared with baseline.

Selective reporting (reporting bias)Unclear riskResults using different outcome measures for 15 year follow-up reported in Ibrahim 2007. No protocol available.
Other biasUnclear riskNo obvious source of other bias. However, the baseline characteristics only presented for followed up participants.

Thordarson 1996

  1. a

    AOFAS Hindfoot scale scores 0 to 100 with higher scores indicating greater improvement
    Calcaneal Fracture Scoring system (pain, work, walking ability and use of walking aids) scores 0 to 100 with higher scores indicating greater improvement
    Foot Function Index (3 subscales of pain, disability and activity restriction) scores 0 to 100 with higher scores indicating greater impairment

Methods

Follow up: 9 to 25 months

Setting: Los Angeles, California. Single centre, one participating surgeon.

Participants

Sample size = 34, of these, 4 elected not to participate before randomisation
Randomised = 30 (Note that an abstract reports 31 were enrolled and randomised)
Surgical: n = 15
Conservative: n = 15
Age: surgical: mean 35 years (range 23 to 57 years); conservative: mean 36 years, (range 24 to 47).

Sex (M/F): surgical 12/3; conservative: 9/2.

Inclusion criteria: displaced unilateral intra-articular fracture (Sanders Classification II and III). All had preoperative CT scan.

Exclusion criteria: displaced Sanders type IV, peripheral vascular disease, diabetes, systemic illness, drug or alcohol abuse, psychotics or bilateral injuries, unwilling to participate in study.

Interventions

Surgery: Open reduction through an L-shaped lateral approach, rigid fixation with contoured reconstruction plate and screws (first half of study) or calcaneal Y plate (second half of study). Early range of movement exercises from day 3 postoperatively. Non-weight-bearing for 10 weeks, then partial weight-bearing, then full weight-bearing at 12 weeks postoperatively.

Conservative: Ice, elevation and bulky Jones bandage dressing until oedema improved then fitted with a removable posterior splint. Followed by early range of motion exercises. Non-weight-bearing for 8 weeks.

Outcomes

Follow-up: surgical group mean 17 months, range 11 to 25 months; conservative group: 14 months, range 9 to 23 months.

Composite outcome index (American Orthopaedic Foot and Ankle Society (AOFAS)), scores ranged from 0 to 100 (pain, daily activity, shoe wear, walking, exercise and work). Range of motion of subtalar joint, Bohler's angle, residual displacement of posterior facet.

NotesAlthough 26/30 completed the functional questionnaire, only 11/30 participants had a physical examination conducted by an independent examiner (8 surgical, 3 conservative) in outpatient clinic at follow-up. Clinical data are thus based on 11/30 (37%) of the original sample.
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear riskNot stated how sequence generated.
Allocation concealment (selection bias)Unclear risk"Drawing a sealed unmarked envelope with type of treatment enclosed within."
Blinding (performance bias and detection bias)
All outcomes
Unclear riskNot reported. A subset of 37% participants were examined by independent clinician. All surgery conducted by single surgeon.
Incomplete outcome data (attrition bias)
All outcomes
High riskTotal 4/30 (13%) lost to follow-up by 15 months: 1 surgical and 3 conservative. 37% of participants were examined by an independent examiner at follow-up (8 surgical, 3 conservative).
Selective reporting (reporting bias)Unclear riskNo protocol available.
Other biasUnclear riskSmall risk from use of unvalidated scoring system although questionnaire was found to correlate highly with the validated AOFAS. Change in surgical procedure halfway through the trial.

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Bajammal 2005A review of trials and other evidence relating to the management of calcaneal fractures. Searches conducted up to December 2005.
Bondi 2007A review of the treatment of calcaneal fractures. Searches conducted up to December 2006.
Bridgman 2002A systematic review of RCTs; searches conducted up to December 1998. Two related publications.
Buzzard 2003An RCT comparing two types of conservative therapy.
Cross 1999This "prospective trial on conservative versus operative treatment of type 2 and type 3 calcaneal fractures" was registered in the UK-NRR archive. The listed contact confirmed that approximately 12 participants were recruited but the study was not completed. Furthermore, the study was not an RCT (email communication Mr Anthony Cross, 9th May 2012 & 16th July 2012).
Erdmann 1992An RCT comparing the use of impulse pneumatic devise on both operative and non-operative treatment.
Gougoulias 2009A systematic review of RCTs; searches conducted up to December 2008.
Holecek 2002Not a randomised study
Meggitt 2000This was listed as a centre in a "multi-centre prospective randomised controlled trial to compare operative with non-operative treatment of displaced intra-articular fractures of the calcaneus". We can find no supporting evidence of a multi-centre trial in the UK during 1997 and 2000.
O'Farrell 1993Not a randomised study. Patients were sequentially enrolled within each group (prospective comparison only). Three related publications (abstract, paper and letter).
Qi 2009Translated from Chinese into English. A study comparing two surgical techniques.
Randle 2000A review and meta-analysis; searches conducted up to 1996.
Schepers 2012Dutch RCT from ISRCTN register. Trial discontinued January 2012 due to low participant recruitment (n = 14). No data to publish (author contact 20th July 2012).
Tennent 2001A non-randomised comparative study.
Thermann 1998A review with searches conducted up to 1997.
Triffitt 1993A letter about an unrelated study.
Wang 2007A systematic review of studies already included in this review

Characteristics of ongoing studies [ordered by study ID]

UK heel fracture trial

Trial name or titleUK Heel fracture trial: surgical treatment versus non-operative care
MethodsMulticentre randomised controlled trial
ParticipantsAll patients with a closed displaced intra-articular fracture of the calcaneus, aged over 18, either sex. No upper age limit. Target recruitment: 150 participants.
InterventionsOpen reduction and internal fixation by extensile lateral approach versus non-surgical treatment with elevation and ice followed by splintage and early mobilisation.
OutcomesKerr Calcaneal Fracture Score.
Starting dateRegistered in 2006.
Contact informationMr Damian Griffin, Warwick Medical School, University of Warwick, Coventry, UK.
Notes

http://www.controlled-trials.com/ISRCTN37188541

Recruitment closed in 2010. Data analysis is ongoing; 150 participants were recruited (May 2012).

Ancillary