Interventions for treating acute elbow dislocations in adults

  • Review
  • Intervention

Authors


Abstract

Background

Dislocation of the elbow joint is a relatively uncommon injury.

Objectives

To assess the effects of various forms of treatment for acute simple elbow dislocations in adults.

Search methods

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (April 2011), the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2011 Issue 1), MEDLINE (1948 to March Week 5 2011), EMBASE (1980 to 2011 Week 14), PEDro (April 2011), CINAHL (April 2011), various trial registers, various conference proceedings and bibliographies of relevant articles.

Selection criteria

Randomised or quasi-randomised controlled trials of conservative and surgical treatment of dislocations of the elbow in adults. Excluded were trials involving dislocations with associated fractures, except for avulsion fractures.

Data collection and analysis

Data extraction and assessment of risk of bias were independently performed by two review authors. There was no pooling of data.

Main results

Two small randomised controlled trials, involving a total of 80 participants with simple elbow dislocations, were included. Both trials were methodologically flawed and potentially biased.

One trial, involving 50 participants, compared early mobilisation at three days post reduction versus cast immobilisation. At one year follow-up, the recovery of range of motion appeared better in the early mobilisation group (e.g. participants with incomplete recovery of extension: 1/24 versus 5/26; risk ratio 0.22, 95% confidence interval 0.03 to 1.72). However, the results were not statistically significant. There were no reports of instability or recurrence. One person in each group had residual pain at one year.

The other trial, involving 30 participants, compared surgical repair of the torn ligaments versus conservative treatment (cast immobilisation for two weeks). At final follow-up (mean 27.5 months), there were no statistically significant differences between the two groups in the numbers of patients who considered their injured elbow to be inferior to their non-injured elbow (10/14 versus 7/14; RR 1.43, 95% CI 0.77 to 2.66) or in other patient complaints about their elbow such as weakness, pain or weather-related discomfort. There were no reports of instability or recurrence. There were no statistically significant differences between the two groups in range of motion of the elbow (extension, flexion, pronation, and supination) or grip strength at follow-up. No participants had neurological disturbances of the hand but two surgical group participants had recurrent dislocation of the ulnar nerve (no other details provided). One person in each group had radiologically detected myositis ossificans (bone formation within muscles following injury).

Authors' conclusions

There is insufficient evidence from randomised controlled trials to determine which method of treatment is the most appropriate for simple dislocations of the elbow in adults. Although weak and inconclusive, the available evidence from a trial comparing surgery versus conservative treatment does not suggest that the surgical repair of elbow ligaments for simple elbow dislocation improves long-term function. Future research should focus on questions relating to non-surgical treatment, such as the duration of immobilisation.

Résumé scientifique

Interventions pour le traitement de la luxation aiguë du coude chez l'adulte

Contexte

La luxation du coude est une blessure relativement rare.

Objectifs

Évaluer les effets de diverses formes de traitement pour les cas aigus de luxation simple du coude chez l'adulte.

Stratégie de recherche documentaire

Nous avons effectué une recherche dans le registre spécialisé du groupe Cochrane sur les traumatismes ostéo-articulaires et musculaires (avril 2011), le registre Cochrane des essais contrôlés (The Cochrane Library 2011, numéro 1), MEDLINE (de 1948 à la 5ème semaine de mars 2011), EMBASE (de 1980 à la 14ème semaine de l'année 2011), PEDro (avril 2011), CINAHL (avril 2011), divers registres d’essais cliniques, divers actes de conférence et les bibliographies d'articles pertinents.

Critères de sélection

Des essais contrôlés randomisés ou quasi-randomisés sur des traitements conservateurs et chirurgicaux des luxations du coude chez l'adulte. Ont été exclus les essais impliquant des luxations liées à des fractures, sauf pour les fractures-avulsions.

Recueil et analyse des données

Deux auteurs ont extrait des données et évalué les risques de biais de façon indépendante. Nous n'avons effectué aucun regroupement de données.

Résultats principaux

Deux petits essais contrôlés randomisés portant au total sur 80 participants atteints d'une luxation simple du coude, ont été inclus. Les deux essais étaient méthodologiquement défectueux et potentiellement biaisés.

Un essai, impliquant 50 participants, avait comparé la mobilisation précoce trois jours après la réduction versus l'immobilisation plâtrée. Après un an de suivi, la récupération de l'amplitude de mouvement s'est avérée meilleure dans le groupe à mobilisation précoce (par ex. les participants avec une récupération incomplète de l'extension : 1/24 versus 5/26 ; risque relatif 0,22 ; intervalle de confiance à 95 % 0,03 à 1,72). Cependant, les résultats n'étaient pas statistiquement significatifs. Aucun cas d'instabilité ou de récidive n'avait été signalé. Une personne dans chaque groupe souffrait de douleur résiduelle après un an.

L'autre essai, impliquant 30 participants, avait comparé la réparation chirurgicale des ligaments déchirés à un traitement conservateur (immobilisation plâtrée pendant deux semaines). En fin de suivi (27,5 mois en moyenne), il n'y avait pas de différences statistiquement significatives entre les deux groupes quant au nombre de patients considérant leur coude blessé inférieur à leur coude non-blessé (10/14 versus 7/14 ; RR 1,43 ; IC à 95 % 0,77 à 2,66) ou quant aux autres plaintes des patients concernant leur coude, telles que faiblesse, douleur ou inconfort lié aux conditions météo. Aucun cas d'instabilité ou de récidive n'avait été signalé. Il n'y avait pas de différences statistiquement significatives entre les deux groupes lors du suivi dans l'amplitude de mouvement du coude (extension, flexion, pronation et supination) ou la force de préhension. Aucun des participants n'avait souffert de troubles neurologiques de la main, mais deux participants des groupes de chirurgie avaient eu une luxation récidivante du nerf cubital (aucun autre détail fourni). Une personne dans chaque groupe avait eu une myosite ossifiante détectée radiologiquement (formation d'os dans les muscles suite à une blessure).

Conclusions des auteurs

Il n'y a pas suffisamment de données issues d'essais contrôlés randomisés pour déterminer quelle est la méthode de traitement la plus appropriée pour les luxations simples du coude chez l'adulte. Bien que faibles et peu concluantes, les données issues d'un essai comparant un traitement chirurgical à un traitement conservateur ne montrent pas que la réparation chirurgicale des ligaments du coude pour une luxation simple du coude améliore le fonctionnement à long terme. Les recherches futures devraient se concentrer sur des questions relatives au traitement non chirurgical, telle que la durée d'immobilisation.

Plain language summary

Interventions for treating acute elbow dislocations in adults

Elbow dislocation is where the joint surfaces of the elbow become completely separated from each other. It is a relatively uncommon injury. After the bones of the elbow joint are put back into place, under sedation and/or anaesthesia, the arm is usually immobilised in a cast for a week or more. Removal of the cast is often followed by physical therapy aimed at restoring elbow mobility. Surgery is usually reserved for the more severe dislocations, which are generally associated with a fracture (broken bone).

This review includes two trials, involving a total of 80 adults with simple elbow dislocations that had been put back into place (reduced). Both trials were at risk of bias, which means that their results may not be reliable.

One trial compared early mobilisation of the elbow with immobilisation for three weeks in a plaster cast. This trial found no firm evidence of differences between the two interventions in the recovery of elbow range of motion or pain at one year. None of the trial participants had an unstable elbow or had suffered another dislocation.

The other trial compared surgical repair of the torn ligaments versus conservative treatment (cast immobilisation for two weeks). It found no significant difference between the two groups in the numbers of patients who considered their injured elbow to be inferior to their non-injured elbow or in other patient complaints about their elbow such as weakness, pain or weather-related discomfort. There were also no differences between the groups in the range of motion of the elbow or grip strength at follow-up of around two years. There were two people with surgery-related complications. None of the trial participants had an unstable elbow or had suffered another dislocation.

Overall, the review concluded that there was not enough evidence from randomised controlled trials to show which methods of treatment are better for these injuries.

Résumé simplifié

Interventions pour le traitement de la luxation aiguë du coude chez l'adulte

Il y a luxation du coude lorsque les surfaces articulaires du coude se séparent complètement les unes des autres. Il s'agit d'une blessure relativement rare. Une fois les os de l'articulation du coude remis en place, sous sédation et/ou anesthésie, le bras est généralement immobilisé dans un plâtre pendant au moins une semaine. Le retrait du plâtre est souvent suivi d'une physiothérapie visant à rétablir la mobilité du coude. La chirurgie est habituellement réservée aux luxations les plus graves, généralement associées à une fracture.

Cette revue inclut deux essais portant sur un total de 80 adultes atteints de luxations simples du coude déjà remises en place (réduites). Les deux essais présentaient un risque de biais, ce qui signifie que leurs résultats pourraient ne pas être fiables.

Un essai avait comparé la mobilisation précoce du coude à l'immobilisation dans le plâtre pendant trois semaines. Cet essai n'a trouvé aucune preuve solide de différences après un an entre les deux interventions, quant à la récupération de l'amplitude de mouvement du coude ou la douleur. Aucun des participants à l'essai n'avait un coude instable ni n'avait souffert d'une autre luxation.

L'autre essai avait comparé la réparation chirurgicale des ligaments déchirés à un traitement conservateur (immobilisation plâtrée pendant deux semaines). Il n'avait constaté aucune différence significative entre les deux groupes quant au nombre de patients considérant leur coude blessé inférieur à leur coude non-blessé ou quant aux autres plaintes des patients concernant leur coude, telles que faiblesse, douleur ou inconfort lié aux conditions météo. Il n'y avait pas non plus de différences entre les groupes dans l'amplitude de mouvement du coude ou la force de préhension après un suivi d'environ deux ans. Deux personnes avaient souffert de complications liées à une intervention chirurgicale. Aucun des participants à l'essai n'avait un coude instable ni n'avait souffert d'une autre luxation.

Au total, la revue a conclu qu'il n'y avait pas suffisamment de données issues d'essais contrôlés randomisés pour indiquer quelles sont les meilleures méthodes de traitement pour ces blessures.

Notes de traduction

Traduit par: French Cochrane Centre 1st June, 2012
Traduction financée par: Ministère du Travail, de l'Emploi et de la Santé Français

எளியமொழிச் சுருக்கம்

பெரியவர்களில் கடுமையான முழங்கை இடப்பெயர்விற்கு சிகிச்சை அளிப்பதற்கான தலையீடுகள்

முழங்கை மூட்டின் இணைப்பு பரப்புகள், ஒன்றிலிருந்து மற்றொன்று முற்றிலுமாக பிரிக்கப்பட்ட நிலையே முழங்கை இடப்பெயர்வு ஆகும். ஒரு ஒப்பீட்டளவில், இது ஒரு அபூர்வமான காயமாக உள்ளது. தூக்க மருந்து மற்றும்/அல்லது மயக்க மருந்தின் கீழ் முழங்கை மூட்டு எலும்புகள் மீண்டும் அதன் இடத்தில் பொருத்தப்பட்ட பிறகு, கை பொதுவாக ஒரு வாரம் அல்லது அதற்கு மேற்பட்ட நாட்கள் ,ஒரு மாவுக்கட்டினால் அசைவற்ற நிலையில் வைக்கப்பட்டிருக்கும் . கட்டுகள் அவிழ்க்கப்பட்ட பிறகு, முழங்கை இயக்கத்தை மீட்சி செய்யும் நோக்கத்துடன் இயன் முறை சிகிச்சை பெரும்பாலும் தொடர்ந்து வருகிறது. பொதுவாக, அறுவை சிகிச்சை மிகவும் கடுமையான இட பெயர்வுக்கென்று ஒதுக்கப்பட்டுள்ளது, அவை பொதுவாக, ஒரு எலும்பு முறிவோடு (முறிந்த எலும்பு) தொடர்புடையதாக இருக்கும் .

சாதாரண முழங்கை இடப்பெயர்வு ஏற்பட்டு, அது மீண்டும் சரியான இடத்தில் பொருத்தப்பட்ட (குறைக்கப்பட்ட) மொத்தம் 80 பெரியவர்கள் சம்பந்தப்பட்ட இரண்டு சோதனைகளை, இந்த திறனாய்வு கொண்டுள்ளது. இரண்டு சோதனைகளும் ஒருதலை சார்பின் அபாயத்தை கொண்டிருந்தது, அப்படியென்றால் அச்சோதனைகளின் முடிவுகள் நம்பகமானதாக இல்லாமல் இருக்கலாம் என்று அர்த்தம்.

ஒரு சோதனை, முழங்கையை இயக்குகிற சிகிச்சையோடு ஒரு மாவுக்கட்டினில் முழங்கையை மூன்று வாரங்களுக்கு அசைவற்ற நிலையில் வைத்திருக்கும் சிகிச்சையை ஒப்பிட்டது. இந்த சோதனையானது, ஒரு வருடக் காலத்தில் முழங்கையின் இயக்க வரம்பின் மீட்பில் அல்லது வலியின் அளவில் இரு தலையீடுகளுக்கும் இடையே வேறுபாடுகள் இருப்பதற்கான எந்த ஒரு உறுதியான ஆதாரத்தையும் காணவில்லை. சோதனை பங்கேற்பாளர்கள் எவரும் ஒரு ஸ்திரமற்ற முழங்கையை பெற்றிருக்கவோ அல்லது மற்றொரு இடப்பெயர்வை அனுபவிக்கவோ இல்லை .

மற்றொரு சோதனை, கிழிந்த தசைநார்களை அறுவை சிகிச்சை கொண்டு சீர்ப்படுத்தும் முறைக்கு எதிராக பாரம்பரிய சிகிச்சை முறையோடு ( இரண்டு வாரங்களுக்கு மாவுக்கட்டு கொண்டு அசைவற்ற நிலையில் வைப்பது) ஒப்பிட்டது . தங்களது காயமடையாத முழங்கையோடு ஒப்பிடுகையில், தங்களது காயமடைந்த முழங்கையின் வலு குறைந்துள்ளது என்று கருதிய நோயாளிகளின் எண்ணிக்கையிலும் தங்கள் முழங்கையில் இருக்கும் பலவீனம், வலி அல்லது வானிலை-தொடர்பான கோளாறுகள் போன்றவற்றைக் குறித்து முறையிடும் நோயாளிகளின் எண்ணிக்கையிலும் இரண்டு குழுக்களுக்கு இடையே பெரிய அளவில் வித்தியாசம் இல்லை. மேலும், இரண்டு ஆண்டுகள் பின் தொடர்தலின் போது, முழங்கையின் இயக்க வரம்பு அல்லது பிடி வலிமையில் இரண்டு குழுக்களுக்கிடையே எவ்வித வித்தியாசமும் இல்லை. அறுவை-சிகிச்சை தொடர்பான சிக்கல்களுடன் இருவர் இருந்தனர். சோதனை பங்கேற்பாளர்கள் எவரும் ஒரு ஸ்திரமற்ற முழங்கையை பெற்றிருக்கவோ அல்லது மற்றொரு இடப்பெயர்வை அனுபவிக்கவோ இல்லை.

ஒட்டுமொத்தத்தில், இப்படிப்பட்ட காயங்களுக்கு எவ்வகையான சிகிச்சை அதிக சிறப்பானது என்பதை காண்பிக்க சீரற்ற கட்டுப்பாட்டு சோதனைகளில் இருந்து கிடைத்த ஆதாரம் போதுமானதாக இல்லை என்று இந்த திறனாய்வு முடிவு செய்தது.

மொழிபெயர்ப்பு குறிப்புகள்

மொழி பெயர்ப்பாளர்கள்: ப்ளசிங்டா விஜய், சிந்தியா ஸ்வர்ணலதா ஸ்ரீகேசவன், தங்கமணி ராமலிங்கம், ஸ்ரீகேசவன் சபாபதி.

Background

Description of the condition

The elbow is where three bones (the humerus or upper arm bone and the two forearm bones: the radius and ulna) come together. The ends of the three bones are shaped to form three joint surfaces (articulations) that are contained within a single cavity. The elbow acts as both a hinge joint, which allows bending (flexion) and straightening (extension), and a pivot joint that allows the hand to be rotated palm upwards (supination) and palm downwards (pronation).

The elbow is one of the most stable joints in the body. As well as having highly congruous (well matched) joint surfaces, it is further stabilised by the surrounding soft tissue structures. These include the medial and lateral collateral ligaments, joint capsule and muscular structures. The most important stabiliser to valgus stress is the anterior band of the medial collateral ligament (Morrey 1983). The lateral ulnar collateral ligament and the radial collateral ligaments resist posterolateral rotatory instability and varus stresses.

Elbow dislocation is where the joint surfaces become separated. The separation can be complete or partial. The latter is also called subluxation. The most common injury mechanism is where a person falls onto an outstretched hand. The resulting (valgus, supination and axial) force transmits to the elbow and separates the forearm bones from the humerus. As the elbow is being dislocated, there is a typical sequence of injury: the lateral ligament tears first, followed by the anterior capsule and posterior capsule and, finally, the medial collateral ligament. In complete elbow dislocations both the medial and lateral collateral ligaments are disrupted. Fractures of the bone ends occur in more severe elbow dislocations (Rockwood 2001). Our review only includes ‘simple’ dislocation involving soft tissue disruption, with the exception of avulsion fractures where fragments of bone are torn away with the soft tissue from their attachment points. Dislocations with an associated fracture are termed 'complex' dislocations will not be included. Over 90% of elbow dislocations occur in a posterior or posterolateral direction. Anterior or medial dislocations are comparatively rare.

The annual incidence of elbow dislocation has been reported as six to eight dislocations per 100,000 adults. Approximately 60% of dislocations affect the nondominant arm (Josefsson 1986). Elbow dislocations occur more frequently in males and the highest incidence occurs in the 10 to 20 year age group; the median age is 30 years. Approximately 10% to 50% are sports related but dislocations are not unique or common to any particular sport (Hobgood 2008).

Description of the intervention

Typically, elbow dislocation is treated by closed reduction, where the displaced parts are gently manipulated back in place, under sedation and/or anaesthesia. The elbow is then assessed for stability. If stable, the elbow is then immobilised at 90 degrees for between 7 to 14 days in a brace or cast (Rockwood 2001). Removal of the cast is usually followed by physical therapy aimed at restoring mobility. Surgical intervention is usually reserved for dislocations that cannot be reduced safely using closed reduction methods or those that are unstable. Unrecognised fractures may cause a block to reduction or the radial head may become entrapped in the soft tissues of the joint (Hobgood 2008). Surgical intervention includes, where appropriate, open reduction, repair and reattachment of various soft tissues. If the joint remains unstable following soft tissue repair then a hinged external fixator may be applied (Hobgood 2008). Physical therapy will generally be prescribed after a period of immobilisation to allow healing.

Why it is important to do this review

Long term sequelae from elbow dislocations include pain, recurrent instability, heterotrophic ossification (where bone forms in the wrong places) and loss of range of motion (Josefsson 1984; Melhoff 1988). These unsatisfactory outcomes show the need for an evaluation of current practice. Although there is some consensus on the indications for conservative and surgical management, there is still variation in practice (Rockwood 2001). Additionally, the best type and duration of immobilisation, methods of mobilisation and surgical strategies are unclear (Hobgood 2008; Melhoff 1988).

Objectives

To assess the effects (benefits and harms) of interventions for treating acute simple elbow dislocations in adults.

We aimed to compare:
1. different methods of closed reduction;
2. different types of post-reduction splinting (functional brace versus plaster cast);
3. different durations of immobilisation, including compared with no immobilisation or early mobilisation;
4. surgical (e.g. repair of soft-tissue structures) versus non-surgical (conservative) intervention (typically, closed reduction and immobilisation);
5. different types of surgery, specifically side of repair of soft-tissue structures, and use of external fixation.

Methods

Criteria for considering studies for this review

Types of studies

Randomised and quasi-randomised (for example, allocation by hospital number or date of birth) controlled trials comparing different interventions for treating acute elbow dislocations in adults.

Types of participants

Skeletally mature patients with radiologically confirmed acute elbow dislocations. We included only 'simple' dislocation involving soft tissue disruption, with the exception of avulsion fractures. We excluded participants with dislocations with associated fractures or with neurovascular deficit after reduction. Trials with mixed populations, either in terms of participant maturity or type of elbow dislocation, were considered for inclusion provided separate data were available for adults with simple dislocations or the number of participants not meeting the review inclusion criteria were very few.

Types of interventions

For inclusion, trials needed to compare interventions used to treat acute elbow dislocations. For practical reasons, they were to be grouped under the following headings.
1. Non-operative: closed reduction, post reduction cast immobilisation, post reduction functional bracing, early mobilisation, late mobilisation
2. Operative: open reduction, medial soft tissue repair, lateral soft tissue repair, external fixation

Trials evaluating use and types of anaesthesia, analgesia or sedation for closed reduction or surgery were excluded; as were those evaluating use, timing or types of examination, such as an arthrogram.

Types of outcome measures

Primary outcomes
  • Functional outcome: activities of daily living and return to work/ leisure activities. Ideally, these should be validated scores such as Short Form-36 (SF-36), the Disability of the Arm, Shoulder and Hand questionnaire (DASH), Mayo elbow score, American Shoulder and Elbow Surgeons Elbow Assessment form and Patient Rated Elbow Evaluation.

Secondary outcomes
  • Clinical outcome: range of motion, grip strength

  • Further or recurrent dislocation

  • Pain

  • Early and late complications associated with elbow dislocations or their treatment, including reflex sympathetic dystrophy (RSD) and osteoarthrosis; wound complications; nerve injury and heterotrophic ossification.

Search methods for identification of studies

Electronic searches

We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (April 2011), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Wiley Online Library 2011, Issue 1), MEDLINE (OvidSP 1948 to March Week 5 2011), EMBASE (OvidSP 1980 to 2011 Week 14), the Physiotherapy Evidence Database (PEDro) (April 2011), and CINAHL (EBSCOhost 1937 to April 2011). No language restrictions were applied.

In MEDLINE, the sensitivity-maximizing version of the Cochrane Highly Sensitive Search Strategy for identifying randomised controlled trials (Lefebvre 2011) was combined with the subject specific search (see Appendix 1). Search strategies are also shown for The Cochrane Library, EMBASE and CINAHL (see Appendix 1).

We searched the following web sites to identify additional unpublished and ongoing studies: Current Controlled Trials, Centre Watch; Trials Central, WHO International Clinical Trials Registry Platform (all to June 2010) and the UK National Research Register (to September 2007). We also searched the following sites for conference proceedings: the American Society for Surgery of the Hand, the Orthopaedic Trauma Association, the Journal of Bone and Joint Surgery - British Volume, the Journal of Bone and Joint Surgery - American Volume, and the American Academy of Orthopaedic Surgeons (to June 2010).

Searching other resources

We checked the reference lists of articles, reviews and textbooks for possible relevant studies.

Data collection and analysis

Selection of studies

Two review authors (FT and MS) screened the title, abstract and descriptors of identified studies for possible inclusion. The full text of potential studies were then obtained, where possible. From the full text, two authors independently assessed potentially eligible trials for inclusion and resolved any disagreement through discussion.

Data extraction and management

Trial details and data were independently extracted by two authors (FT and MS) using a pre-piloted data extraction form and if necessary adjudicated by a third author before being entered into RevMan. Study design, characteristics of study population, interventions, duration of treatments and outcomes were recorded. Attempts were made to contact trial authors for missing data and trial information.

Assessment of risk of bias in included studies

Two review authors (FT and MS) independently assessed risk of bias using The Cochrane Collaboration's 'Risk of bias' tool (Higgins 2008). They were not blinded to author and source institution. Included items were sequence generation for randomisation, concealment of allocation, blinding (of participants, care providers and outcome assessors), incomplete outcome data, selective outcome reporting and other potential sources of bias (for example, an extreme baseline imbalance in patient characteristics). Any disagreement was resolved by consensus.

Measures of treatment effect

We calculated risk ratios (RR) with 95% confidence intervals (95% CI) for dichotomous data, and mean differences (MD) and 95% CIs for continuous data. Should studies be pooled in future, we plan to calculate mean differences (MD) and 95% CIs if studies used the same outcome measures for continuous data. If studies use different but comparable continuous outcome measures, we plan to use standardised mean differences (SMD) with 95% CIs.

Unit of analysis issues

In each study, the unit of randomisation is the individual patient.

Dealing with missing data

Where possible, we performed intention-to-treat analyses that included all participants randomly assigned to the intervention groups. Should this be possible in future, we would investigate the effect of drop outs and exclusions, initially by conducting worst and best scenario analyses. We were alert to the potential mislabelling or non identification of standard errors and standard deviations. Should there have been missing standard deviations that could not have been derived from confidence interval data, we would not have assumed values in order to present these in the analyses.

Assessment of heterogeneity

We specified a priori that heterogeneity would be identified by visually examining the forest plots and consideration of the Cochrane Q statistic and I² values. Decisions regarding heterogeneity would then be made on the basis of the clinical effect. We planned to report this decision in the text.

Assessment of reporting biases

Should sufficient data have been available, we would have attempted to assess publication bias by preparing a funnel plot. Our search of 'grey literature' and pursuit of trials listed in clinical trial registers should have helped to avoid publication bias.

Data synthesis

Should the pooling of data be possible and appropriate in future, we will pool data using the fixed-effect model and 95% confidence intervals. We will consider using a random-effects model where there is excessive and unexplained heterogeneity.

Subgroup analysis and investigation of heterogeneity

There were insufficient data to conduct subgroup analyses. In our protocol, we set out planned subgroup analyses by age, gender, type and duration of the dislocation, and patient subgroup (e.g. athletes, military recruits, others). Additionally, we planned to explore the potential effects of treatment variations among trials testing comparable comparisons in an attempt to explain heterogeneity.

Sensitivity analysis

There were insufficient data to conduct our planned sensitivity analyses, for testing either the exclusion of trials at high or unclear risk of selection bias or the effects of missing data.

Results

Description of studies

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

Results of the search

A total of 383 references were identified by the electronic database searches: the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (6); Cochrane Central Register of Controlled Trials (24); MEDLINE (92); EMBASE (176); Physiotherapy Evidence Database (8); CINAHL (77). After study selection, two trials were included (Josefsson 1987; Rafai 1999) and five were excluded (Bek 2009; Fan 1995; Josefsson 1984a; Maripuri 2007; Taha 2000). One ongoing trial was also identified (NTR2025) by a search of the WHO International Clinical Trials Registry Platform.

Both included studies were fully reported in medical journals. The main report for Josefsson 1987 was in English and for Rafai 1999, in French. The latter was translated into English by one review author (JCT). Unsuccessful requests were made for information from the trial investigators of both trials.

Included studies

More extensive details of the individual trials are presented in the Characteristics of included studies.

Design

Both included trials were parallel randomised controlled trials with two intervention groups.

Setting

Both trials were single-centre trials conducted in a hospital setting. Josefsson 1987 took place in Malmo, Sweden and Rafai 1999 in Casablanca, Morocco. Neither trial reported on the period of trial recruitment.

Interventions

Josefsson 1987 compared surgical repair of torn ligaments with conservative management (cast immobilisation for two weeks), while Rafai 1999 compared early mobilisation starting at three days with cast immobilisation for three weeks.

Participants

The two trials involved a total of 80 adults with 80 dislocated elbows. The proportion of male participants was 33% in Josefsson 1987 and 86% in Rafai 1999; and the mean ages were 35 and 25 years respectively. The youngest recorded participant was 16 years old and the oldest was 70 years old.

Outcomes

Final follow-up was at an average of 27.5 months (range 12 to 59 months) in Josefsson 1987, and at 12 months in Rafai 1999. Neither trial reported on validated patient reported measures of upper-limb function. However, Josefsson 1987 reported on the return to previous occupation, and patient complaints relating to function. Both trials reported on range of motion and instability. Josefsson 1987 also reported on complications.

Excluded studies

The full reasons for excluding five studies are given in the Characteristics of excluded studies. Two studies (Bek 2009; Taha 2000) were excluded because they involved a paediatric population. We were unable to locate a copy of a Chinese trial (Fan 1995). We excluded Josefsson 1984a because its focus was on the use of arthrography, and Maripuri 2007 because it was not randomised.

Ongoing studies

One ongoing study was identified (NTR2025).This multi-centre randomised clinical trial is comparing functional treatment versus plaster cast immobilisation for simple elbow dislocations. The study commenced in August 2009, with a recruitment target of 100 participants and a one year follow-up. For more information, see the Characteristics of ongoing studies.

Risk of bias in included studies

Figure 1 presents the risk of bias judgements for the individual items for the two trials.

Figure 1.

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

Allocation

Josefsson 1987 used random selection from a pool of sealed envelopes, while Rafai 1999 allocated by drawing lots. The lack of information to judge whether there was adequate sequence generation or allocation concealment meant that we judged that both trials had an unclear risk of selection bias.

Blinding

Blinding of participants and care providers was not possible in either trial. Additionally, neither trial report mentioned assessor blinding. We decided that both trials could be at high risk of detection bias.

Incomplete outcome data

The differences between the two groups in the length of follow-up in Josefsson 1987 and the discrepancies between text and figures in Rafai 1999 prompted unclear risk of bias judgements for this item.

Selective reporting

While there was insufficient information, including a lack of trial protocols, to permit judgement, we considered that neither trial was at high risk of reporting bias given that both reported on a typical set of outcomes for people with elbow dislocation.

Other potential sources of bias

There was a lack of information to judge on other potential sources of bias; for instance bias resulting from major imbalances in key baseline characteristics.

Effects of interventions

The two included trials tested different comparisons.

Early mobilisation versus cast immobilisation

Rafai 1999 compared early mobilisation versus cast immobilisation for three weeks in 50 adults, who were followed up for one year. At one year, one participant of the early mobilisation group versus five in the cast immobilisation failed to regain full extension. The same results applied for the recovery of flexion and pronation-supination (see Analysis 1.1); the difference between the two groups was not statistically significant (risk ratio (RR) 0.22, 95% confidence interval (CI) 0.03 to 1.72). One person in each group had residual pain at one year (see Analysis 1.2). There were no reports of instability or recurrence.

Surgical versus conservative treatment

Josefsson 1987 compared surgical versus conservative treatment in 30 adults, of whom 28 were available at follow-up of one year or more (mean 27.5 months). At final follow-up, none of the trial participants had changed their occupation because of their injury. Also at this time, there was no significant difference between the two groups in the numbers who considered their injured elbow to be inferior to their non-injured elbow (10/14 versus 7/14; RR 1.43, 95% CI 0.77 to 2.66; see Analysis 2.1); nor were there differences between the two groups in other patient complaints such as weakness, pain or weather-related discomfort (see Analysis 2.1). There were no cases of instability, subluxation or recurrent dislocation in either group. Josefsson 1987 also found no statistically significant differences between the two groups in elbow range of motion (extension, flexion, pronation, and supination) or grip strength at follow-up. Analysis 2.2 shows the data for extension and flexion at 10 weeks and final follow-up. These data show the tendency for worse extension in the surgery group; this is reflected also in the higher incidence of subjectively-reported limitations in extension in this group. No participants had neurological disturbances of the hand. Two participants in the surgery group had recurrent dislocation of the ulnar nerve (there were no further details given). One person in each group had radiologically detected myositis ossificans; both patients had reduced extension.

Discussion

Summary of main results

This review includes two randomised controlled trials, each testing a different comparison, in people with simple elbow dislocations.

One trial (Rafai 1999), involving 50 participants, compared early mobilisation at three days post reduction versus cast immobilisation. At one year follow-up, the recovery of range of motion appeared better in the early mobilisation group but the results were not statistically significant. There were no reports of instability or recurrence. One person in each group had residual pain at one year.

The other trial (Josefsson 1987), involving 30 participants, compared surgical repair of torn ligaments versus conservative treatment (two weeks cast immobilisation). At final follow-up (mean 27.5 months), there were no statistically significant differences between the two groups in patient-reported complaints about their elbow such as pain or weakness. There were no reports of instability or recurrence. Josefsson 1987 found no statistically significant differences between the two groups in elbow range of motion or grip strength at follow-up. Two participants of the surgery group had recurrent dislocation of the ulnar nerve, and one person in each group had radiologically detected myositis ossificans.

Overall completeness and applicability of evidence

There is a lack of evidence to address all five comparisons set out in our objectives. The available evidence is limited to two small under-powered randomised controlled trials, both of which found no statistically significant differences between outcomes. Nonetheless, the interventions and study populations (although demographically different) of the two included trials are relevant to current practice. Additionally, although sub-optimal, the outcomes assessed by both trials are relevant. However, the lack of assessment of patient-reported function in Rafai 1999 greatly reduces its usefulness.

Quality of the evidence

Both trials included in this review had methodological weaknesses that make them susceptible to bias. There was no assurance of allocation concealment in either trial and both were at high risk of detection bias, reflecting the lack of blinding of outcome assessment. Overall, the quality of the available evidence is low.

Potential biases in the review process

While our search was comprehensive, it is possible that we have missed small trials that are unreported or only reported in conference abstracts. Additionally, although we anticipate that it would not have been suitable, we were unable to obtain a copy of a trial reported in Chinese. Our attempts to contact trial authors for further clarification of trial methods were unsuccessful.

Agreements and disagreements with other studies or reviews

A recent systematic review (de Haan 2009) included the same two randomised controlled trials that we have included and three comparative observational studies. Based on the results of Josefsson 1987, de Haan 2009 found there was no difference between surgical treatment and plaster immobilisation. However, on the inclusion of data from observational studies, de Haan 2009 found a better outcome for functional treatment (early mobilisation) versus plaster immobilisation. Our restriction to evidence from randomised controlled trials does not allow for this second finding. de Haan 2009 concluded that the quality of the available evidence is low, which is in agreement with our findings.

Authors' conclusions

Implications for practice

Overall, there is a lack of evidence to inform clinical decisions for treating acute simple elbow dislocations in adults. Nonetheless, clinicians should note that, while weak and inconclusive, the available evidence from a trial comparing surgery versus conservative treatment did not suggest that the surgical repair of elbow ligaments for simple elbow dislocation improved long-term function.

Implications for research

Future research should focus on questions relating to non-surgical treatment, such as the duration of immobilisation. The results of the multi-centre ongoing trial (NTR2025) should help inform both future practice and on whether there is a need for further trials on the key comparison of early mobilisation (functional treatment) versus plaster cast immobilisation for simple elbow dislocations that are stable after reduction. All future research evaluating key interventions for these injuries should meet robust contemporary standards of design, conduct, and reporting, including the use of secure randomisation methods and validated outcome measures of function and health-related quality of life.

Acknowledgements

Many thanks to Joanne Elliott, Lindsey Elstub, Helen Handoll, Mario Lenza and Kerry O'Connell for their helpful feedback during editorial review of the review. Thanks too to Christine Dalais for library support.

Data and analyses

Download statistical data

Comparison 1. Early mobilisation versus cast immobilisation
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Range of motion deficiencies1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 Incomplete recovery of extension at 12 months1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.2 Incomplete recovery of flexion at 12 months1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.3 Incomplete recovery of pronosupination at 12 months1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
2 Pain and instability1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
2.1 Residual pain1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
2.2 Instability / recurrence1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 1.1.

Comparison 1 Early mobilisation versus cast immobilisation, Outcome 1 Range of motion deficiencies.

Analysis 1.2.

Comparison 1 Early mobilisation versus cast immobilisation, Outcome 2 Pain and instability.

Comparison 2. Surgery versus conservative treatment
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Patient complaints1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 Injured elbow inferior to non-injured elbow1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.2 Limited motion (extension)1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.3 Weakness1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.4 Weather-related discomfort1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.5 Pain on effort1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.6 Tenderness1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.7 Pain at rest1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.8 Feeling of instability1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
2 Range of motion (compared with contralateral side)1 Mean Difference (IV, Fixed, 95% CI)Totals not selected
2.1 Extension (degrees) at 10 weeks1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
2.2 Extension (degrees) at > 1 year1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
2.3 Flexion (degrees) at 10 weeks1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
2.4 Flexion (degrees) at > 1 year1 Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]
3 Complications1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
3.1 Recurrent dislocation of ulnar nerve1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
3.2 Myositis ossificans1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 2.1.

Comparison 2 Surgery versus conservative treatment, Outcome 1 Patient complaints.

Analysis 2.2.

Comparison 2 Surgery versus conservative treatment, Outcome 2 Range of motion (compared with contralateral side).

Analysis 2.3.

Comparison 2 Surgery versus conservative treatment, Outcome 3 Complications.

Appendices

Appendix 1. Search strategies

The Cochrane Library (Wiley Online Library)

#1 MeSH descriptor Elbow, this term only (108)
#2 MeSH descriptor Elbow Joint, this term only (151)
#3 (#1 OR #2) (253)
#4 MeSH descriptor Dislocations, this term only (169)
#5 MeSH descriptor Joint Instability, this term only (413)
#6 (#4 OR #5) (564)
#7 (#3 AND #6) (18)
#8 ((elbow* or ulnohumeral or radiohumeral) NEAR/3 (dislocat* or sublux* or instability or unstable))::ti,ab,kw (21)
#9 (#7 OR #8) (24)

MEDLINE (OvidSP)

1 (Elbow/ or Elbow Joint/) and (Joint Instability/ or Dislocation/) (1812)
2 ((elbow$ or ulnohumeral or radiohumeral) adj3 (dislocat$ or sublux$ or instability or unstable)).tw. (1058)
3 or/1-2 (2089)
4 Randomized controlled trial.pt. (303135)
5 Controlled clinical trial.pt. (82081)
6 randomized.ab. (210341)
7 placebo.ab. (123185)
8 Drug therapy.fs. (1438791)
9 randomly.ab. (152769)
10 trial.ab. (217176)
11 groups.ab. (1018216)
12 or/4-11 (2656661)
13 exp Animals/ not Humans/ (3561297)
14 12 not 13 (2252839)
15 and/3,14 (92)

EMBASE (OvidSP)

1. Elbow Dislocation/ (787)
2. Elbow/ and Dislocation/ (700)
3. ((elbow$ or ulnohumeral or radiohumeral) adj3 (dislocat$ or sublux$ or instability or unstable)).tw. (1207)
4. or/1-3 (1947)
5. exp Randomized Controlled Trial/ (293412)
6. exp Double Blind Procedure/ (102620)
7. exp Single Blind Procedure/ (14142)
8. exp Crossover Procedure/ (30643)
9. Controlled Study/ (3484988)
10. or/5-9 (3552508)
11. ((clinical or controlled or comparative or placebo or prospective$ or randomi#ed) adj3 (trial or study)).tw. (542170)
12. (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).tw. (134423)
13. ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$)).tw. (131769)
14. (cross?over$ or (cross adj1 over$)).tw. (55817)
15. ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or experiment$ or intervention$ or treatment$ or therap$ or control$ or group$)).tw. (161395)
16. or/11-15 (812984)
17. or/10,16 (3932783)
18. limit 17 to human (2378993)
19. and/4,18 (176)

CINAHL (EBSCO)

S1 (MH "Elbow Dislocation") (93)
S2 (MH "Elbow") OR (MH "Elbow Joint") (2120)
S3 (MH "Dislocations") OR (MH "Joint Instability") (4882)
S4 S2 and S3 (204)
S5 TX (elbow* N3 dislocate*) or (elbow* N3 sublux*) or (elbow* N3 instability) or (elbow* N3 unstable) (140)
S6 TX (ulnohumeral N3 dislocate*) or (ulnohumeral N3 sublux*) or (ulnohumeral N3 instability) or (ulnohumeral N3 unstable) (3)
S7 TX (radiohumeral N3 dislocate*) or (radiohumeral N3 sublux*) or (radiohumeral N3 instability) or (radiohumeral N3 unstable) (0)
S8 S5 or S6 or S7 (142)
S9 S1 or S4 or S8 (352)
S10 (MH "Clinical Trials+") (113165)
S11 (MH "Comparative Studies") (61009)
S12 (MH "Prospective Studies+") (144906)
S13 (MH "Crossover Design") (7533)
S14 (MH "Double-Blind Studies") or (MH "Single-Blind Studies") or (MH "Triple-Blind Studies") (24216)
S15 (MH "Placebos") (6535)
S16 (MH "Random Assignment") (28713)
S17 PT Clinical Trial (58106)
S18 TI ( (clinical or controlled or comparative or placebo or prospective or randomised or randomized) and (trial or study) ) or AB ( (clinical or controlled or comparative or placebo or prospective or randomised or randomized) and (trial or study) ) (166061)
S19 TI ( random* and (allocat* or allot* or assign* or basis* or divid* or order*) ) or AB ( random* and (allocat* or allot* or assign* or basis* or divid* or order*) ) (25945)
S20 TI ( (singl* N1 blind*) or (doubl* N1 blind*) or (trebl* N1 blind*) or (tripl* N1 blind*) or (singl* N1 mask*) or (doubl* N1 mask*) or (trebl* N1 mask*) or (tripl* N1 mask*) ) or AB ( (singl* N1 blind*) or (doubl* N1 blind*) or (trebl* N1 blind*) or (tripl* N1 blind*) or (singl* N1 mask*) or (doubl* N1 mask*) or (trebl* N1 mask*) or (tripl* N1 mask*) ) (14503)
S21 TI ( crossover or cross-over or "cross over" ) or AB ( crossover or cross-over or "cross over" ) (5692)
S22 S10 or S11 or S12 or S13 or S14 or S15 or S16 or S17 or S18 or S19 or S20 or S21 (377080)
S23 S9 and S22 (Published Date from: -20100631) (77)

PEDro

1. Abstract & Title: dislocate
Body Part: Forearm or elbow
Match all search terms (AND)  (4)

2. Abstract & Title: sublux
Body Part: Forearm or elbow
Match all search terms (AND)  (4)

3. Abstract & Title: instability
Body Part: Forearm or elbow
Match all search terms (AND)  (1)

4. Abstract & Title: unstable
Body Part: Forearm or elbow
Match all search terms (AND) (0)

5. Abstract & Title: pulled
Body Part: Forearm or elbow
Match all search terms (AND)  (2)

History

Protocol first published: Issue 3, 2009
Review first published: Issue 4, 2012

Contributions of authors

This review was initiated by Fraser Taylor who conceived and designed the review. The review was produced in collaboration with Martyn Sims, Peter Herbison and Jean Claude Theis, and was coordinated by Fraser Taylor.

Declarations of interest

None known.

Sources of support

Internal sources

  • Otago District Health Board, New Zealand.

    Funding for one review author (FT) to attend training courses in May 2008. Martyn Sims is an employee of Otago District Health Board.

  • University of Otago, New Zealand.

    Professor Peter Herbison and Associate Professor Jean Claude Theis are employees of the University of Otago.

External sources

  • No sources of support supplied

Differences between protocol and review

The Science Citation Index (ISI) and the Library and Information Science and Technology Abstracts were not available for searching and are therefore not included.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Josefsson 1987

MethodsRandomisation method: pooled sealed envelopes
Assessor blinding: not stated
Loss to follow-up: 2 participants (7%)
ParticipantsEmergency Room, Malmo General Hospital, Sweden
Period of study: not stated
30 participants
Inclusion criteria: acute elbow dislocation, 16 years old or older, previously symptom free elbow
Exclusion criteria: dislocation with concomitant fracture (unless small avulsed fracture)
Diagnosis: not stated, presume clinical and radiological.
Presentation: acute
Sex: 10 male (33%)
Age: mean 35 years; range 16 to 70 years
InterventionsDislocations were initially reduced and immobilised in the emergency department. Elbows were then re-examined under general anaesthetic (mean 4 days later, range 1 to 7 days).
1. Surgery. Both the medial and lateral sides of the joint were explored by two separate lengthwise incisions. The muscles originating from the epicondyles were inspected as were the medial and lateral collateral ligaments and anterior capsule and brachialis muscle. Ligamentous and muscular injuries were sutured in their substance or via epicondylar drill holes using absorbable polyglycolic acid sutures. The elbows were then immobilised for a planned two weeks in plaster cast at 90 degrees of flexion. After removal of the cast active motion of the elbow was encouraged.
2. Conservative treatment. The elbows were then immobilised for a planned two weeks in plaster cast at 90 degrees of flexion. After removal of the cast active motion of the elbow was encouraged.
Assigned: 15/15
Analysed: 14/14 at follow-up
OutcomesLength of follow-up: mean 27.5 months, 12 to 59 months (also, 5 and 10 weeks)
Elbow range of motion: extension, flexion, pronation and supination
Varus and valgus stability
Neurological evaluation, including grip strength
Flexion and extension strength
Patient 'complaints': limited motion, weakness, discomfort, pain, instability, subluxation, recurrent dislocation
X-ray at follow-up: myositis ossificans
Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk"... random selection from a pool of thirty sealed envelopes." "Thirty consecutive patients..."
Allocation concealment (selection bias)Unclear risk"... random selection from a pool of thirty sealed envelopes. Fifteen of the envelopes indicated surgical and 15 indicated non-surgical treatment." Potential lack of allocation concealment once group size of 15 reached. Adequate safeguards not apparent.
Blinding (performance bias and detection bias)
All outcomes
High riskParticipants or clinicians unable to be blinded. No mention of blinding of outcome assessors.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskOne patient in each group unable to attend follow-up. Unlikely to affect conclusions. However, variable timing of follow-up (mean follow-up was 31 months in the surgical group versus 24 months in the conservative treatment group.
Selective reporting (reporting bias)Unclear riskInsufficient information available.
Other biasUnclear riskStudy appears to be free of other sources of bias.

Rafai 1999

MethodsRandomisation method: drawing of lots
Assessor blinding: not stated
Loss to follow-up: not reported
ParticipantsCentre Hospitaliare Universitaire Ibn Rochd, Casablanca, Morocco
Period of study: over 2 years
50 consecutive participants.
Inclusion criteria: young person, normal psychological profile, posterior dislocation of elbow, stable reduction of the elbow, no previous elbow problems
Exclusion criteria: unstable reduction of elbow
Diagnosis: posterior dislocation of the elbow in adults
Presentation: acute, within 24 hours of injury
Sex: 43 male (86%)
Age: mean 25 years; range 16 to 67 years
Interventions

Reduction under general anaesthesia, and stability checks before:
1. Early mobilisation: mobilisation started after 3 days (if appropriate). Self-rehabilitation at 3 times a day for 10 minutes increasing range of mobilisation over time. For the first 3 weeks, the arm was kept in a sling when not exercising.
2. Immobilisation: plaster cast immobilisation at 90 degrees for 3 weeks, followed by rehabilitation.

Assigned: 26/24
Analysed: 26/24 at follow-up

Outcomes

Length of follow up: 12 months (also at 7, 15, 21, 36 and 51 days, and 2, 3 and 6 months for group 1 and 21, 36 and 51 days, and 2, 3 and 6 months for group 2). Thus, 9 visits for group 1 and 7 visits for group 2

Elbow range of motion: extension, flexion, pronation and supination (second pair were reported together)
Pain
Instability and recurrence

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk"Nous avons mené une étude prospective randomisée". "La méthode thérapeutique a été choisie par tirage au sort .." Translated as "drawing of lots"; but still unclear.
Allocation concealment (selection bias)Unclear risk"La méthode thérapeutique a été choisie par tirage au sort ..". Translated as "drawing of lots". Adequate safeguards not apparent.
Blinding (performance bias and detection bias)
All outcomes
High riskParticipants and personnel unable to be blinded. No mention of blinding of outcome assessors.
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskBased on calculated percentages in the text, all participants were accounted for. However, the figures in the trial report gave a different answer.
Selective reporting (reporting bias)Unclear riskInsufficient information available.
Other biasUnclear riskStudy appears to be free of other sources of bias. However, baseline characteristics were not split by treatment group.

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Bek 2009Pulled elbow rather than dislocated elbow. Paediatric population.
Fan 1995We were unable to obtain a copy of this Chinese trial, nor its abstract. It may not be randomised.
Josefsson 1984aWhile the allocation of surgery and non-surgery in 14 patients was randomised, this was a study of the use of arthrography for diagnosing ligament injury.
Maripuri 2007Retrospective non-randomised study.
Taha 2000Pulled elbow rather than dislocated elbow. Paediatric population.

Characteristics of ongoing studies [ordered by study ID]

NTR2025

Trial name or titleFunctional treatment versus plaster for simple elbow dislocations (FuncSiE): a randomised trial
MethodsMulti-centre randomised clinical trial
ParticipantsPatients aged 18 years or older with a simple elbow dislocation that can be reduced. Target sample size: 100
Interventions1. Functional treatment group: The affected arm will be put in a pressure bandage for up to three weeks. Early active movements within the limits of pain are allowed. Usually by the second day the patients are instructed to do two exercises by a physical therapist, which are gradually expanded if tolerated.
2. Plaster group: The affected arm will be put in plaster of Paris for three weeks. At three weeks after dislocation the plaster will be removed and full mobilisation (flexion, extension, pronation and supination) will be initiated by practicing under supervision of a physical therapist. Physical therapy sessions will be held at regular intervals, preferably 2 times a week during 12 weeks.
OutcomesPrimary outcome (Quick-DASH) and secondary outcomes (MEPI, Oxford Elbow Score, pain, range of motion, secondary intervention rates, complication rates, SF-36, and EQ-5D) will be compared at baseline, at 1, 3 and 6 weeks, and at 3, 6, and 12 months after start of treatment, using both univariate and multivariable analyses. Costs for (in)formal healthcare consumption will be determined for both interventions. Cost-effectiveness will be expressed as cost per quality of life year (QALY) gained.
Starting date26 Aug 2009; planned closing date: 31 Dec 2012
Contact informationD den Hartog, MD
Erasmus MC, Dept of Surgery-Traumatology Mailbox H-822k 's-Gravendijkwal 230, 3015 CE Rotterdam P.O. Box 2040, 3000 CA Rotterdam, The Netherlands
Tel: +31-10 7031050
Fax: +31-10 7032396
d.denhartog@erasmusmc.nl
NotesA protocol for this trial is available.