A Prospective Randomised Trial to Assess Early versus Delayed Weight Bearing Following Operatively Treated Ankle Fractures in the United States
Journal of Orthopaedic Trauma · 14 Oct 2026
† Impact is the editorial-priority score. All scores are out of 100. Clinical is a stored clinical-importance score from the earlier method; it has not been recalculated.
Why it matters
Ankle fracture fixation is one of the most common orthopaedic trauma operations, and this trial supports letting selected patients bear weight at 2 weeks rather than restricting them until 6 weeks.
The evidence
This 19-centre US randomised trial compared starting weight bearing as tolerated at 2 weeks after surgical fixation of unstable ankle fractures (without fixed syndesmotic injury) against touch-down weight bearing until 6 weeks, in 418 analysed adults. Reoperation for complications was rare in both groups (5 of 214 early vs 7 of 204 delayed). Early weight bearing met the non-inferiority criterion, with a complication-free survival difference of 1.5 percentage points (90% CI -1.7 to 4.8). Median return to work was 54 vs 69 days, a difference that was not statistically significant (HR 1.1, 95% CI 0.8 to 1.6).
Reoperation for complications (complication-free survival) within 365 days of randomization: Risk difference 1.5 (95% CI -1.7 to 4.8; percentage points). The interval excludes inferiority beyond the reported margin. Relative to the reported margin of -5; margin justification and the trial's analysis assumptions still require appraisal.
Why this rigour score?
Multicentre RCTDesign starting point: 63.4
Raised the score
- Concealed allocation+5.1
- Prospectively registered+5.1
Lowered the score
- Underpowered−8.5
Methods at a glance
Recorded assessment- Outcome assessors blindedMet
- Allocation concealedMet
- Random sequence generatedMet
- Intention-to-treat analysisMet
- Adequate statistical powerUnderpowered
- Prospective registrationMet
Not reported does not mean not done. Checks have different weights; this is not a count of boxes ticked.
See the full score breakdown
- Study design starting point
- 63.4
- Concealed allocation
- +5.1
- Random sequence generation
- +2.5
- Compared against current standard of care
- +3.4
- Blinded outcome assessment
- +3.4
- Intention-to-treat analysis
- +3.4
- 4% loss to follow-up
- +0.6
- Underpowered
- −8.5
- Prospectively registered
- +5.1
- Reverse fragility index 7
- +3.4
- Final rigour score rounded
- 82 / 100
Study design sets the starting point and a ceiling of 100. Recorded methods then adjust the score. Points are shown to one decimal place; the final score uses unrounded values.
Checklist from the stored appraisal. “Not met” describes the recorded criterion; it does not always produce a deduction. This overview supports reading the full study.
For journal club
1.Which ankle fracture patients (for example those with syndesmotic fixation, osteoporosis, neuropathy, or BMI of 40 or more) would you still restrict from early weight bearing, given that they were excluded here?
2.How would you counsel a manual laborer about expected return to work if you allow weight bearing at 2 weeks, given the 15-day shorter but non-significant median time seen in this trial?
Original publication title
A Prospective Randomized Trial to Assess Early versus Delayed Weight Bearing Following Operatively Treated Ankle Fractures in the United States