PrEvention of Posttraumatic Joint contractuRes With Ketotifen 2
PERK2
2 other identifiers
interventional
395
2 countries
15
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2019
Longer than P75 for phase_3
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2018
CompletedFirst Posted
Study publicly available on registry
July 10, 2018
CompletedStudy Start
First participant enrolled
April 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2024
CompletedDecember 4, 2025
August 1, 2025
5.4 years
March 25, 2018
November 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Elbow Extension-Flexion Arc of Motion
The change in range of motion between baseline and 12 weeks post-randomization
12 weeks post-randomization
Secondary Outcomes (5)
Range of Motion at other time points
6 weeks, 24 weeks, 52 weeks
Patient Reported Outcome Measures
Enrolment - 52 weeks
Patient Reported Outcome Measures
Enrolment - 52 weeks
Patient Reported Outcome Measures
Enrolment - 52 weeks
Radiographs
Enrolment - 52 weeks
Study Arms (3)
Lactose Placebo
PLACEBO COMPARATORLactose Placebo by mouth twice per day
Ketotifen Fumarate - 2mg
ACTIVE COMPARATORKetotifen Fumarate 2 mg by mouth twice per day
Ketotifen Fumarate - 5mg
ACTIVE COMPARATORKetotifen Fumarate 5 mg by mouth twice per day
Interventions
2 mg tablets (over-encapsulated into one capsule) by mouth twice per day
5 mg tablets (over-encapsulated into one capsule) by mouth twice per day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- United States Department of Defensecollaborator
- University of Calgarylead
Study Sites (15)
University of Maryland Medical Centre
Baltimore, Maryland, 21201, United States
Carolinas Medical Center
Charlotte, North Carolina, 28204, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4, Canada
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
South Health Campus
Calgary, Alberta, T3M 1M4, Canada
Sturgeon Community Hospital
St. Albert, Alberta, T8N 6C4, Canada
Royal Columbia Hospital
New Westminster, British Columbia, V3L 3W7, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
St. Joseph's Health Care London
London, Ontario, N6A 4V2, Canada
The Ottawa General Hospital
Ottawa, Ontario, K1H 8L6, Canada
The Ottawa Civic Hospital
Ottawa, Ontario, K1Y 4E9, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Related Publications (1)
Ademola A, Hildebrand KA, Schneider PS, Mohtadi NGH, White NJ, Bosse MJ, Garven A, Walker REA, Sajobi TT. PrEvention of posttraumatic contractuRes with Ketotifen 2 (PERK 2) - protocol for a multicenter randomized clinical trial. BMC Musculoskelet Disord. 2020 Feb 24;21(1):123. doi: 10.1186/s12891-020-3139-2.
PMID: 32093652DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin A Hildebrand, MD, FRCSC
University of Calgary and Alberta Health Services
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Department of Surgery, Principal Investigator
Study Record Dates
First Submitted
March 25, 2018
First Posted
July 10, 2018
Study Start
April 26, 2019
Primary Completion
September 29, 2024
Study Completion
December 17, 2024
Last Updated
December 4, 2025
Record last verified: 2025-08