Skip to main content
. 2023 Nov 7;2023(11):CD008628. doi: 10.1002/14651858.CD008628.pub3

Buckley 2002.

Study characteristics
Methods RCT, parallel design, 2‐armed trial
Participants Total number of randomised participants: 424 (471 fractures)
Source population: initially 7 centres (14 surgeons) in Canada recruited, but data from only 4 (6 surgeons) were included as they complied with the requirement of a minimum of 20 participants followed up for at least 2 years from each participating surgeon
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
Overall baseline characteristics
  • Age, mean (SD): 40 (± 11) years

  • Sex (M/F): 381/43

  • Bilateral fractures: no information on numbers by treatment arm; however, the lead author reported that 47/310 (15%) participants recruited from 1 centre had bilateral fracture

  • Workers' compensation: 157/424 (37%) work‐related injury


Baseline characteristics for surgical group
  • Age, mean: 41 years


Baseline characteristics for non‐surgical group
  • Age, mean: 39 years

Interventions Surgical group
  • Number randomised: 206 (249 fractures)

  • Losses (with reasons): 45 (35 lost to follow‐up, 7 fused, 3 died)

  • Number analysed: for complications: 218 (262 fractures); for all other outcomes: 206*

  • Treatment description: ORIF involving extended lateral approach, use of plate, screw, or wire fixation. Autografting left to surgeon discretion. Physiotherapy started after 6 weeks for all participants.


Non‐surgical group
  • Number randomised: 218 (262 fractures)

  • Losses (with reasons): 70 (29 lost to follow‐up, 37 fused, 4 died)

  • Number analysed: for complications: 206 (249 fractures); for all other outcomes: 218*

  • Treatment description: ice, elevation, rest. Physiotherapy started after 6 weeks for all participants.


*Flow of participant information is not clearly reported in the text. Although 64 participants were lost to follow‐up, complication data for these participants were tracked by nurses. Study authors report "complete case" data for 242 participants for function and HRQoL, but they do not describe how they accounted for lost participants in these data.
Outcomes Timing of assessments: 2 to 4 weeks, 6, 12, 26, 52 weeks, and 2 (minimum) to 8 years (maximum)
Outcomes reported in review: quality of life (SF‐36), disease‐specific scale (VAS) (primary outcomes); Böhler's angle, postoperative complications (treatment failure/subtalar arthrodesis)
Note: we did not report data for Böhler angle because we could not determine whether the data were between time points (before and after surgery) or between intervention groups (surgical and non‐surgical) or were mean postoperative data.
Notes Study dates: April 1991 to December 1997
Funding sources: not reported
Declarations of interest: not reported
Notes:
  • Sample size varied across publications. Contact was made (JB) with the lead study author (email 20 November 2011), and data were requested (SD values for VAS, SF‐36 scores and Böhler angles, clarification about sample size differences between different publications from 2 to 8 years' follow‐up). Lead study author responded (25 November 2011), but trial data were stored on floppy discs and unable to access for conversion to CD format. Original paper records were archived and held for 10 years, but not possible to access without extra time/resources.

  • Of the 206 surgical procedures, 73% were conducted by lead study author.

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

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number tables used after eligible for entry into study. Random numbers generated at the site of the Principal Investigator.
Allocation concealment (selection bias) Low risk Central administrative site sent random number assignments to study centres.
Blinding of participants and personnel (performance bias)
All outcomes High risk Due to nature of intervention, treating surgeons and participants were not blinded to the intervention
Blinding of outcome assessment (detection bias)
All outcomes High risk Outcome assessment by postal questionnaire sent to study participants (primary outcome of quality of life). Assessment of CT scans to assess quality of reduction was conducted by lead study author who was not blinded.
Incomplete outcome data (attrition bias)
All outcomes High risk 309/424 (73%) followed up for minimum of 2 years, maximum of 8 years (mean 3 years). Response rate to questionnaire is not clearly reported. A later publication by O'Brien 2004 stated that 319 participants completed the RCT at 2 to 8 years but reported different SF‐36 values from the main paper (Buckley 2002).
We also noted 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.
Study report states that intention‐to‐treat analysis was conducted. However, 44 cases (44/424 (10%)) who went on to have subtalar fusion were excluded from analyses.
Selective reporting (reporting bias) Unclear risk No protocol or clinical trials registration. It is not feasible to effectively assess risk of selective reporting bias without these documents.
Other bias Low risk We identified no other sources of bias