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 range21 Years
SexALL
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…