Investigations of Mechanisms and Treatment in Post-traumatic Joint Contractures (NCT01902017) | Clinical Trial Compass
CompletedPhase 2
Investigations of Mechanisms and Treatment in Post-traumatic Joint Contractures
Canada152 participantsStarted 2013-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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), Foothills Medical Centre (FMC) or South Health Campus (SHC).
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.