PrEvention of posttraumatic contractuRes with Ketotifen 2 (PERK 2)
Injuries and resulting stiffness around joints, especially the elbow, have huge psychological effects by reducing quality of life through interference with normal daily activities such as feeding, dressing, grooming, and reaching for objects. Pre-clinical models and a pilot randomized clinical trial (RCT) demonstrated the feasibility and safety of using Ketotifen Fumarate (KF), a mast cell stabilizer to prevent elbow joint contractures. PERK2 is a phase III randomized, controlled, double-blinded multicentre trial parallel group (KF 2 mg or 5 mg or lactose placebo twice daily orally for 6 weeks) study which enrolls over 700 adults with elbow fractures/dislocation enrolled within 7 days of injury. This study aims to evaluate the efficacy of KF in reducing joint contracture severity in adult participants with operately treated elbow fractures and/or dislocations.