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PrEvention of post-traumatic contractuRes with Ketotifen 1 (PERK 1): A randomized clinical trial.

OBJECTIVE
To assess the use of Ketotifen Fumarate (KF) to reduce post-traumatic contractures following 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 non-operatively managed isolated distal humerus or proximal radius +/- ulna fractures or elbow dislocations within seven days of injury.


INTERVENTIONS
KF 5 mg (n=74) or lactose-Placebo (PL, n=77) orally twice daily for six weeks.


MAIN OUTCOMES
Primary outcome elbow flexion-extension arc range of motion (ROM) at 12 weeks post-randomization. Safety measures including serious adverse events (SAE) and radiographic fracture line disappearance from 2 to 52 weeks post-randomization.


RESULTS
The elbow ROM (mean, confidence interval) was not significantly different between KF (122°, 118°-127°) and PL (124°, 119°-130°) groups (p=0.56). There was a significant difference in elbow ROM at 12 weeks post-randomization comparing operative (117°, 112°-122°) vs non-operative groups (128°, 124°-133°) irrespective of intervention (p=0.0011). There were 11 SAE (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 time was similar between groups. There was one non-union in each group.


CONCLUSIONS
In a population of operative and non-operatively managed elbow fractures and/or dislocations KF did not reduce post-traumatic contractures. The administration of KF in this population was not found to result in a significantly higher number of major adverse events when compared to placebo.


LEVEL OF EVIDENCE
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.