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 motionPatients 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
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