Immediate versus delayed weight bearing for fractures of the pelvis, acetabulum, distal femur, and proximal and distal tibia: a feasibility randomized controlled trial
Bibliographic record
Abstract
BACKGROUND: Early weight bearing is frequently allowed and encouraged following fixation of hip and femoral and tibial shaft fractures, while pelvis, acetabulum, and lower extremity periarticular fractures are often prescribed 6-12 weeks of restricted weight bearing. Our objective was to perform a feasibility randomized trial of immediate versus delayed weight bearing as tolerated (WBAT) for fractures of the pelvis, acetabulum, distal femur, and proximal and distal tibia. METHODS: A parallel two-arm pilot feasibility trial was performed at one academic level I trauma center in the United States. Patients with a fracture of the pelvis, acetabulum, distal femur, proximal tibia, or distal tibia were eligible. Patients were randomized to either immediate WBAT or delayed (≥ 6 weeks) weight bearing after surgery. Our feasibility criteria included the following: (1) 25% overall enrollment (surgeon and patient agreement to participate in 50% eligible cases), (2) > 90% follow-up at 3 months), (3) 100% correct documentation of weight bearing status, and (4) 100% correct documentation of secondary outcome (reoperation). RESULTS: Surgeons allowed inclusion of 64/133 (48.1%) of eligible patients (by fracture type, 76% of pelvis; 43% of acetabulum; 38% of distal femur; 45% of proximal tibia (39% of tibial plateau); and 56% of distal tibia fractures). 50/64 (78%) of these patients agreed to participate in the study, for an overall enrollment of 38% (50/133). The follow-up rate was 46/50 (92%) at the 3-month follow-up. Correct documentation of postoperative weight bearing status and the secondary outcome of reoperation was achieved in all cases 50/50 (100%). There were two reoperations (one hardware failure and one wound infection) in the immediate WBAT group, and none in the delayed weight bearing group. CONCLUSION: All four of the feasibility criteria were met. While we did not meet our target of 50% of patients whom surgeons were willing to randomize, we did exceed the target of 25% overall patient enrollment. This feasibility trial demonstrates that a randomized controlled trial of early versus delayed weight bearing would be feasible for certain fracture types, and these findings will be used to help design future studies in this realm. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05595148.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.007 | 0.008 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".