Multi-Center Trial to Evaluate an Internal Joint Stabilizer - Elbow (NCT01944670) | Clinical Trial Compass
CompletedNot Applicable
Multi-Center Trial to Evaluate an Internal Joint Stabilizer - Elbow
United States26 participantsStarted 2013-08
Plain-language summary
The purpose of this study is to confirm the safety and effectiveness of the Internal Joint Stabilizer - Elbow.
Who can participate
Age range
21 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:
* The subject is \>21 years of age.
* The subject is considered a candidate for the Internal Joint Stabilizer -Elbow (IJS-E) under one of the following indications:
* Subjects where either the elbow sublocates or dislocates after repairing the injured ligaments and/or bones
* The elbow has been subluxated or dislocated for more than 10 days prior to surgery
* The elbow subluxes or dislocates after surgical repair/reconstruction
* The subject has sufficient quantity or quality of bone. Specifically there is sufficient trochlea of the distal humerus and of sufficient quality that the axis pin of the IJS-E has a secure hold as judged by the surgeon intra-operatively. Also, the screws placed in the ulna must be judged by the surgeon to have sufficient hold.
* The subject or legal guardian has been informed of the nature of the study, agrees to its provisions, and has provided informed written consent.
* The subject is willing to be available for the appropriate follow-up for the duration of the study.
Exclusion Criteria:
* The subject has one of the following conditions:
* Presents with limited elbow motion as opposed to instability (subjects where instability is created through surgical release for chronic limitation of movement, soft tissue release, removal of adhesions and heterotopic ossification and/or fascial interposition will be excluded).
* Active infection, suspicion of colonization or quiescent infection
* Bacteremia
* Bone loss g…
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.