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PrEvention of posttraumatic contractuRes with Ketotifen 2 (PERK 2) - protocol for a multicenter randomized clinical
Ayoola Ademola1,2, Kevin A Hildebrand3,4, Prism S Schneider3,5,4
1McCaig Institute of Bone and Joint, University of Calgary, Calgary, Canada. ayoola.ademola@ucalgary.ca.
Background:
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. Over the last several years and through numerous research results, the myofibroblast-mast cell-neuropeptide axis of fibrosis had been implicated in post-traumatic joint contractures. 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. 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.
Methods/Design:
A Phase III randomized, controlled, double-blinded multicentre trial with 3 parallel groups (KF 2 mg or 5 mg or lactose placebo twice daily orally for 6 weeks). The study population consist of adults who are at least 18 years old and within 7 days of injury. The types of injuries are distal humerus (AO/OTA type 13) and/or proximal ulna and/or proximal radius fractures (AO/OTA type 2 U1 and/or 2R1) and/or elbow dislocations (open fractures with or without nerve injury may be included). A stratified randomization scheme by hospital site will be used to assign eligible participants to the groups in a 1:1:1 ratio. The primary outcome is change in elbow flexion-extension range of motion (ROM) arc from baseline to 12 weeks post-randomization. The secondary outcomes are changes in ROM from baseline to 6, 24 & 52 weeks, PROMs at 2, 6, 12, 24 & 52 weeks and impact of KF on safety including serious adverse events and fracture healing. Descriptive analysis for all outcomes will be reported and ANCOVA be used to evaluate the efficacy KF over lactose placebo with respect to the improvement in ROM.
Discussion:
The results of this study will provide evidence for the use of KF in reducing post-traumatic joint contractures and improving quality of life after joint injuries.
Trial Registration:
This study was prospectively registered (July 10, 2018) with ClinicalTrials.gov reference: NCT03582176.
Insights
This study investigates Ketotifen Fumarate (KF) for reducing elbow stiffness after injury. Results will show if KF improves range of motion and quality of life in patients with elbow fractures or dislocations.
Area of Science:
- Orthopedics
- Pharmacology
- Clinical Trials
Background:
- Elbow joint stiffness significantly impacts quality of life due to functional limitations.
- The myofibroblast-mast cell-neuropeptide axis is implicated in post-traumatic joint contractures.
- Ketotifen Fumarate (KF), a mast cell stabilizer, has shown promise in pre-clinical and pilot studies for preventing elbow contractures.
Purpose of the Study:
- To evaluate the efficacy of Ketotifen Fumarate (KF) in reducing post-traumatic elbow joint contracture severity.
- To assess the impact of KF on improving range of motion and quality of life in patients with elbow injuries.
Main Methods:
- Phase III randomized, double-blinded, placebo-controlled multicentre trial.
- Adult participants with operately treated elbow fractures/dislocations randomized to KF (2mg or 5mg) or placebo orally twice daily for 6 weeks.
- Primary outcome: change in elbow flexion-extension range of motion (ROM) at 12 weeks. Secondary outcomes include ROM at other time points, patient-reported outcome measures (PROMs), and safety.
Main Results:
- Data analysis is ongoing; primary and secondary outcomes will be reported.
- Efficacy of KF over placebo in improving ROM will be assessed using ANCOVA.
- Safety profile, including adverse events and fracture healing, will be evaluated.
Conclusions:
- The study is expected to provide evidence for KF's effectiveness in managing post-traumatic elbow stiffness.
- Findings may support the use of KF to improve functional outcomes and quality of life after elbow injuries.
- Results will inform clinical practice regarding pharmacological interventions for joint contractures.
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