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Investigations of Mechanisms and Treatment in Post-traumatic Joint Contractures

Information source: University of Calgary
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Joint Contractures

Intervention: Ketotifen (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Calgary

Official(s) and/or principal investigator(s):
Kevin Hildebrand, MD, Principal Investigator, Affiliation: University of Calgary

Overall contact:
Kimberly D Carcary, MSc, Phone: 403-944-2932, Email: kimberly.carcary@albertahealthservices.ca

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.

Clinical Details

Official title: Randomized, Double Blind, Placebo Controlled Trial of Ketotifen in Patients With Elbow Fractures or Dislocations

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Joint range of motion

Secondary outcome:

Range of motion

Patients requiring (re)operation for elbow-related causes

Radiographic evaluation for fracture healing/non-union

Detailed description: Individuals ≥ 18 years old with isolated distal 1/3 humerus and/or proximal 1/3 ulna and/or proximal 1/3 radius fractures and/or elbow dislocations (open fractures with or without nerve injury may be included) and presenting to Peter Lougheed Centre (PLC). Patients will be required to take Ketotifen 5mg by mouth twice a day for 6 weeks or placebo twice a day by mouth for 6 weeks. Neither the patient nor the physician caring for you will know if they are taking Ketotifen or placebo. Sometimes this type of injury requires surgery. This study will be inviting both patients that do and do not require surgery to participate. We will take a sample of blood to measure tryptase (normally found in your body). We predict people with high levels of tryptase are more likely to develop stiffening in the joint. Patients will be asked to return for follow up visits 2, 6, 12, 24, and 52 weeks after surgery or date of initial injury if surgery is not required. These visits are part of normal care for this type of injury. At the visit patients will be asked to do the following, some of which is not part of normal care. At each visit: Range of motion of the elbow will be assessed, DASH score will be completed- form helping the research group understand the level of disability from this injury, X-rays

until the fracture is considered healed (this is normal treatment), SF12 - questionnaire

about how the patient is feeling and coping with their injury, Additional information will be collected about how the injury is healing and weight will be measured. The patient will be required to have physiotherapy which is normal treatment for this injury. The patient will be contacted by telephone for the week 1, 3, 4 and 5 while taking the study medication. During these times: The patient will be asked about:

- any problems with the study medication

- any new conditions or concerns that have developed

The patient will be reminded:

- of next visit

- to continue to take study drug as instructed

During these telephone contacts, if any problems are detected that cannot be rectified or figured out during the telephone interview, then patients may be asked to attend the Cast clinic to see doctor in person.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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

Locations and Contacts

Kimberly D Carcary, MSc, Phone: 403-944-2932, Email: kimberly.carcary@albertahealthservices.ca

Foothills Medical Centre, Calgary, Alberta T2N 1N4, Canada; Recruiting
Kimberly Carcary, MSc, CCRP, Email: kimberly.carcary@albertahealthservices.ca
Paul J Duffy, MD, Sub-Investigator
Robert Korley, MD, Sub-Investigator
Richard Buckley, MD, Sub-Investigator
Christopher R Martin, MD, Sub-Investigator

Peter Lougheed Centre, Calgary, Alberta T1Y 6J4, Canada; Recruiting
Alexandra Garven, Email: alexandra.garven@albertahealthservices.ca
Kevin Hildebrand, MD, Principal Investigator
Ian Le, MD, Sub-Investigator
David Longino, MD, Sub-Investigator
Aaron Bois, MD, Sub-Investigator
Jeremy Lamothe, MD, Sub-Investigator

South Health Campus, Calgary, Alberta, Canada; Recruiting
Lisa Murphy, Email: lisa.murphy2@albertahealthservices.ca
Neil White, MD, Sub-Investigator

Additional Information

Starting date: June 2013
Last updated: February 26, 2015

Page last updated: August 23, 2015

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