The Posttraumatic Elbow Stiffness Treatment (NCT03015415) | Clinical Trial Compass
CompletedNot Applicable
The Posttraumatic Elbow Stiffness Treatment
Brazil30 participantsStarted 2013-03-03
Plain-language summary
This study compares patients with post traumatic elbow stiffness and evaluate the range of motion improvement with two types of treatment: surgical release versus non-surgical rehabilitation protocol with orthoses.
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:
* Previous history of trauma that evolved with joint stiffness at the elbow
* Range of movement of the elbow less than 100º or extension deficit greater than 30º or flexion less than 130º
* More than six months from the initial trauma;
* Skeletal maturity;
* Have had previous physical therapy without the use of orthotics or continuous passive motion for at least 4 months;
* Absence of the following findings:
* Joint block, with range of motion equal to 0º;
* Neurological limb injury;
* Mental illness or inability to understand preoperative questionnaires;
* Active infection;
* Anterior infection at the elbow;
* Systemic autoimmune diseases. (Eg, systemic lupus erythematosus, rheumatoid arthritis, joint psoriasis, etc.).
* Absence of the following radiographic changes:
* Intra-articular synthesis material;
* Presence of vicious consolidation of the distal articular surface of the humerus and proximal ulna;
* Heterotopic ossification;
* Pseudoarthrosis of previous elbow fracture;
* Elbow incongruity;
* Grade III and IV arthrosis
Exclusion Criteria:
* Non-collaboration with rehabilitation program and postoperative follow-up;
* Need to use external fixator after surgical release due to joint instability;
* Death from non-intervention causes or loss of follow-up before the first functional evaluation (3 months).
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.