PrEvention of Posttraumatic contractuRes with Ketotifen 1 (PERK 1): A Randomized Clinical Trial.

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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