Overview

PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2

Status:
Recruiting
Trial end date:
2022-09-29
Target enrollment:
0
Participant gender:
All
Summary
PrEvention of posttraumatic contractuRes with Ketotifen 2 (PERK 2) is a Phase III randomized, controlled, double blinded multicenter trial with 3 parallel groups (Ketotifen 2 mg or 5 mg or lactose placebo twice daily orally for 6 weeks) and a primary endpoint of elbow extension-flexion range of motion (ROM) arc at 12 weeks post-randomization.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Calgary
Collaborator:
United States Department of Defense
Treatments:
Ketotifen
Criteria
Inclusion Criteria:

- Age ≥ 18 years old; skeletally mature with no growth plates in the elbow

- Distal humerus (AO/OTA type 13) and/or proximal ulna and/or proximal radius fractures
(AO/OTA type 2U1 or 2R1) and/or elbow dislocations (open fractures with or without
nerve injury may be included)

- Operative treatment of the elbow fracture or dislocation

- Injury ≤ 7 days

- Participant has a negative urine or blood serum pregnancy test

Exclusion Criteria:

- Pre-existing elbow contracture

- Elbow arthritis (osteoarthritis, inflammatory arthritis, or nonspecific monoarticular
arthritis)

- Inability to mobilize elbow within 21 days of injury

- Bilateral elbow injury

- Concomitant musculoskeletal or visceral injuries preventing post-operative elbow
therapy

- Oral hypoglycemic medications

- History of epilepsy

- Lactose intolerance

- Language or Cognitive difficulties preventing reliable completion of questionnaires

- Females who are pregnant or breast feeding

- Females of reproductive age or males unwilling to use 2 effective methods of
contraception

- Severe renal impairment

- Severe hepatic impairment

- Prior elbow injury or operation

- Total elbow replacement planned for treatment of injury

- Unlikely to maintain follow up (no fixed address, plans to move out of town in the
next year, states unable to comply with protocol)

- Unwilling or unable to provide written informed consent for trial participation