Full Title
PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2 (PERK2)

Eligibility

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

Contact:
Kelly Trask 902-473-3161, Pager 2147, Kelly.Trask@nshealth.ca

PI
Dr. Andrew Trenholm

Description
PrEvention of posttraumatic contractuRes with Ketotifen 2 (PERK2) 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. The Research Hypothesis is that Ketotifen is superior to a lactose placebo in reducing joint contracture severity in adult participants with isolated elbow fractures or dislocations. The Primary Objective is to determine if Ketotifen given within 7 days of injury can reduce post-traumatic elbow joint contractures when compared to placebo. The Secondary Objectives are: 1) to ascertain the optimal dose of Ketotifen and 2) to compare adverse events in Ketotifen and placebo groups.

Outcome Measures: Range of motion; Disability Arm, Shoulder, Hand; Oxford Elbow Score; Pain Catastrophizing Scale; standardized case report form; radiographic evaluation for fracture healing/non-union; and number of participants requiring reoperation for all elbow related causes, and post-traumatic joint contractures, 2 – 52 weeks post-randomization.

Safety Endpoints: The main safety endpoint for this study is the frequency of adverse events and serious adverse events, and radiographic assessment for non-union and heterotopic ossification (HO), 2 – 52 weeks post-randomization.

Sample size= 702