PrEvention of Posttraumatic contractuRes with Ketotifen 1 (PERK 1): A Randomized Clinical Trial
Bibliographic record
Abstract
OBJECTIVE: To assess the use of ketotifen fumarate (KF) to reduce posttraumatic contractures after elbow fractures and/or dislocations. DESIGN: Randomized clinical trial. SETTING: Three hospitals in Calgary, Canada, including one Level 1 trauma center. PARTICIPANTS: Adults (n = 151) sustaining operative or nonoperatively managed isolated distal humerus or proximal radius ± ulna fractures or elbow dislocations within 7 days of injury. INTERVENTIONS: KF 5 mg (n = 74) or lactose placebo (PL, n = 77) orally twice daily for 6 weeks. MAIN OUTCOMES: Primary outcome elbow flexion-extension arc range of motion (ROM) at 12 weeks postrandomization. Safety measures including serious adverse events and radiographic fracture line disappearance from 2 to 52 weeks postrandomization. RESULTS: The elbow ROM (mean, confidence interval) was not significantly different between KF (122 degrees, 118-127 degrees) and PL (124 degrees, 119-130 degrees) groups (P = 0.56). There was a significant difference in elbow ROM at 12 weeks postrandomization comparing operative (117 degrees, 112-122 degrees) versus nonoperative groups (128 degrees, 124-133 degrees) irrespective of intervention (P = 0.0011). There were 11 serious adverse events (KF = 6, PL = 5) that were those expected in an elbow fracture population potentially taking KF. There was no statistically significant difference in the rates of these events between the groups. The disappearance of fracture lines over the course of time was similar between groups. There was one nonunion in each group. CONCLUSIONS: In a population of operative and nonoperatively managed elbow fractures and/or dislocations KF did not reduce posttraumatic contractures. The administration of KF in this population was not found to result in a significantly higher number of major adverse events when compared with placebo. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".