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 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT01507818
Eligibility Criteria:
Inclusion Criteria:
* MRI diagnosis of rotator cuff tear
* Persistent symptoms despite a minimum of 6 months of failed non-operative management
* Scheduled for primary or revision arthroscopic rotator cuff repair (with or without any of the following: debridement, subacromial decompression, distal clavicle resection, treatment of biceps tendon and /or glenoid labrum pathology, release of capsule).
* Age 40 to 80 years
* Able to read and complete English-language surveys
* Ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects
* Willingness and ability to comply with study product and methods
Exclusion Criteria:
* Diagnosis of adhesive capsulitis requiring global capsular release, instability, fracture, or arthritis
* Any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverter-defibrillator)
* Known narcotic allergy, hepatitis, nephritis, or gastrointestinal ulcer
* Chronic narcotic pain medication dependency
* Vulnerable populations including prisoners, pregnant women, nursing home residents, the Investigator's students and employees, employees of sponsor, those unable to consent for themselves, uninsured subjects or others who could be subject coercion
* Worker's compensation claimant
* Medical condition, in the judgement of the patient's physician, which may interfere with the shoulder surgery or the effectiveness or safety of the study treatment
* Use of oral prednisone in the past 30 days
* Use of any investigational drug or participation in another research study within the past 30 days
* Self-reported diagnosis of autoimmune or inflammatory arthritis (e.g. Rheumatoid Arthritis, Lupus, ets.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT01507818
Study Brief:
Protocol Section:
NCT01507818