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Surgical versus conservative interventions for displaced intra-articular calcaneal fractures

  1. Julie Bruce1,*,
  2. Alasdair Sutherland2

Editorial Group: Cochrane Bone, Joint and Muscle Trauma Group

Published Online: 31 JAN 2013

Assessed as up-to-date: 6 OCT 2011

DOI: 10.1002/14651858.CD008628.pub2


How to Cite

Bruce J, Sutherland A. Surgical versus conservative interventions for displaced intra-articular calcaneal fractures. Cochrane Database of Systematic Reviews 2013, Issue 1. Art. No.: CD008628. DOI: 10.1002/14651858.CD008628.pub2.

Author Information

  1. 1

    University of Warwick, Warwick Clinical Trials Unit, Coventry, UK

  2. 2

    University of Aberdeen, Department of Orthopaedics, Aberdeen, UK

*Julie Bruce, Warwick Clinical Trials Unit, University of Warwick, Gibbet Hill Rd, Coventry, CV4 7AL, UK. julie.bruce@warwick.ac.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 31 JAN 2013

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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


ParticipantsSample 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.


InterventionsSurgery: 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.


OutcomesFollow-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.


NotesFollow-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 riskFollow-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 riskOf 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.


ParticipantsSample 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.


InterventionsSurgery: 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.


OutcomesFollow-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.


ParticipantsSample 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).


InterventionsSurgery: 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.


OutcomesFollow-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 riskLack 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

MethodsFollow up: 9 to 25 months

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


ParticipantsSample 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.


InterventionsSurgery: 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.


OutcomesFollow-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.

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

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

 
Comparison 1. Surgery versus conservative management

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Function (including walking ability)3Mean Difference (IV, Random, 95% CI)Totals not selected

    1.1 Composite VAS score (0-100) at 3 years
1Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

    1.2 AOFAS score (0-100) at 1 year
1Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

    1.3 AOFAS score (0-100) at 15 years
1Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

    1.4 FFI score (0-100) at 15 years
1Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

    1.5 Calcaneal Function Score (0-100) at 15 years
1Mean Difference (IV, Random, 95% CI)0.0 [0.0, 0.0]

 2 Walking ability at a minimum of 1 year1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 No walking difficulty (on all surfaces)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.2 Walk unlimited distance
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.3 No limp
1Risk 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)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    4.1 AOFAS score
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.2 FFI score
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.3 Calcaneal fracture score
1Mean 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 Employment2Risk Ratio (M-H, Random, 95% CI)Subtotals only

    6.1 Return to same work
261Risk Ratio (M-H, Random, 95% CI)1.45 [0.75, 2.81]

    6.2 Return to any work
261Risk Ratio (M-H, Random, 95% CI)1.14 [0.94, 1.37]

 7 Work subscore of the Calcaneal fracture score (at 15 years)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 8 Recreational and daily activities2Risk Ratio (M-H, Random, 95% CI)Totals not selected

    8.1 Return to previous recreation level
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

    8.2 No limitations in daily or recreational activities
1Risk Ratio (M-H, Random, 95% CI)0.0 [0.0, 0.0]

 9 Able to wear same shoes2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    9.1 Able to wear normal shoes
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    9.2 Able to wear all shoes comfortably
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 10 Complications2Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    10.1 Major complications
1424Risk Ratio (M-H, Fixed, 95% CI)1.44 [1.01, 2.04]

    10.2 Sural nerve symptoms
156Risk Ratio (M-H, Fixed, 95% CI)1.65 [0.66, 4.14]

    10.3 Valgus deformity
156Risk 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)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    12.1 Normal ankle movement
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    12.2 Normal subtalar movement
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    12.3 > 50% subtalar movement of the opposite side
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 13 Osteoarthritis of subtalar joint (radiological signs)2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    13.1 At median 80 weeks (1.5 years)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    13.2 Moderate or severe arthritic grading at 15 years
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Table 1. Postoperative and other complications

StudyOutcomeNo. / 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

 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.
 
Table 2. Radiological measurements

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 2007Bohler's angle (mean) post-injury

Mean (SD)
67.7o (7.4)913.8o (11.2)nr

Ibrahim 2007Bohler'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 1996Bohler'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 2002Bohler's angle

Mean (SD)**
?1.3o (nr)?1.9o (nr)0.77

 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