Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT00251160
Eligibility Criteria:
Inclusion Criteria:
* Ages 14 years or greater
* Diagnosis of MDI or MDL-AII. Diagnosis will require two or more of the following:
* Symptomatic translation (pain or discomfort) in one or more directions: anterior, inferior and/or posterior;
* Ability to elicit unwanted glenohumeral translations that reliably produce symptoms with one of the following tests: the anterior and posterior apprehension tests, the anterior and posterior load and shift tests, the fulcrum test, the relocation test, the Fukuda test, and/or the push-pull or stress test with the patient supine;
* Presence of a positive sulcus sign of 1 centimetre or greater gap that reproduces the patient's clinical symptoms of instability and should be both palpable and visible;
* Symptoms of instability: subluxation or dislocation.
* Written informed consent
* Failed at least 6 months of non-operative treatment
* Confirmed capsular-ligamentous redundancy as determined by diagnostic arthroscopy examination.
Exclusion Criteria:
* Neurologic disorder (ie: axillary nerve injury; syringomyelia)
* Cases involving third party compensation
* Patients with primary posterior instability
* A bony abnormality (Hill Sachs/bony Bankart) on standard series of x-rays consisting of a minimum of an anteroposterior view, lateral in the scapular plane and an axillary view
* Presence of a Bankart lesion on arthroscopic exam of the joint
* Presence of an unstable biceps anchor (ie: superior labral anterior and posterior \[SLAP\] lesion) on arthroscopic exam of the joint
* Presence of a full-thickness rotator cuff tear.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT00251160
Study Brief:
Protocol Section:
NCT00251160