PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2 (NCT03582176) | Clinical Trial Compass
CompletedPhase 3
PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2
United States, Canada395 participantsStarted 2019-04-26
Plain-language 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.
Who can participate
Age range18 Years – 95 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ≤ 10 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