Investigations of Mechanisms and Treatment in Post-traumatic Joint Contractures

NCT01902017 | Completed Phase 2

• 1 other identifier: REB15-0081
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 3

Brief Summary

Injured joints, especially at the elbow, are at risk for permanent motion loss, also known as joint contractures. Joint contractures limit the function of an elbow and are a recognized complication that occurs often after a traumatic injury. The benefits of early motion after injury has helped in preventing joint contractures but there are still several patients that develop debilitating joint contractures. Current research suggests that mast cells, which are found in the joint, are key in causing joint contractures. Research has been done using a medication called Ketotifen. Ketotifen has been linked to stabilizing mast cells and preventing the joint contracture. It is hoped that short-term use of this medication after an injury will prevent the contracture from occurring.

Conditions

Joint Contractures

Keywords

Joint; Contracture; Elbow; Fracture; Dislocation

Outcome Measures

Primary Outcomes (1)

• Joint range of motion

  Extension-flexion arc of motion

  12 months post-injury

Secondary Outcomes (3)

• Range of motion

  2,6,12,24 and 52 weeks post injury

• Patients requiring (re)operation for elbow-related causes

  12 months

• Radiographic evaluation for fracture healing/non-union

  12-52 weeks

Study Arms (4)

Operative, Ketotifen

EXPERIMENTAL

Ketotifen 5mg orally twice per day for 6 weeks.

Drug: Ketotifen

Non-operative, Ketotifen

EXPERIMENTAL

Ketotifen 5mg orally twice per day for 6 weeks.

Drug: Ketotifen

Operative, Placebo

PLACEBO COMPARATOR

Placebo oral medication twice daily for 6 weeks.

Drug: Placebo

Non-operative, Placebo

PLACEBO COMPARATOR

Placebo oral medication twice daily for 6 weeks.

Drug: Placebo

Interventions

Ketotifen DRUG

5 mg PO bid

Also known as: Zaditen

Non-operative, Ketotifen; Operative, Ketotifen

Placebo DRUG

5 mg placebo PO bid

Also known as: Lactose Placebo

Non-operative, Placebo; Operative, Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old
• Isolated distal 1/3 humerus fractures
• Proximal 1/3 ulna fractures
• Proximal 1/3 radial fractures
• Elbow dislocations
• Open fractures with or without nerve injury
• Presentation to Peter Lougheed Centre (PLC), Foothills Medical Centre (FMC) or South Health Campus (SHC).

You may not qualify if:

• Pre-existing elbow contracture
• Osteoarthritis of affected elbow
• Inflammatory arthritis of affected elbow
• Gout of affected elbow
• Nonspecific monoarticular arthritis of the affected elbow
• Inability to give informed consent due to irreversible cognitive disorder
• Inability to comply with post-operative physiotherapy
• Injury \> 7 days at the time of presentation
• Inability to mobilize elbow injury within 2 weeks of injury or surgery
• Pregnancy
• Breast feeding
• Oral hypoglycemic medications
• History of epilepsy
• Lactose intolerance

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• American Society for Surgery of the Hand: collaborator
• Workers' Compensation Board, Alberta: collaborator

Study Sites (3)

Peter Lougheed Centre

Calgary, Alberta, T1Y 6J4, Canada

Location

Foothills Medical Centre

Calgary, Alberta, T2N 1N4, Canada

Location

South Health Campus

Calgary, Alberta, Canada

Location

Related Publications (2)

• Liu CS, Ademola A, Zhang M, Garven A, Kopka M, Salo PT, Hart DA, Befus AD, Hildebrand KA. Human serum mast cell tryptase levels in elbow fractures or dislocations and its association with injury severity. J Orthop Res. 2020 Sep;38(9):2015-2019. doi: 10.1002/jor.24642. Epub 2020 Mar 11.

  PMID: 32112583 BACKGROUND

• Hildebrand KA, Schneider PS, Mohtadi NGH, Ademola A, White NJ, Garven A, Walker REA, Sajobi TT; PERK 1 Investigators. PrEvention of Posttraumatic contractuRes with Ketotifen 1 (PERK 1): A Randomized Clinical Trial. J Orthop Trauma. 2020 Dec 1;34(12):e442-e448. doi: 10.1097/BOT.0000000000001878.

  PMID: 32639394 DERIVED

MeSH Terms

Conditions

Contracture; Fractures, Bone; Joint Dislocations

Interventions

Ketotifen

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kevin Hildebrand, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgeon

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 17, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

CA (3)