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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT03488433
Eligibility Criteria:
Inclusion Criteria:
* patients 18 years and above
* male or female Rotator cuff tear patients - adults with a small or medium-sized (less than 3 cm in the anteroposterior dimension) full-thickness tear of supraspinatus and/or infraspinatus tendon, diagnosed with MRI or ultrasound, unresponsive to conservative therapy for \>3 months
Reverse total shoulder arthroplasty patients - adults with rotator cuff arthropathy, glenohumeral joint arthritis with significant glenoid wear or retroversion requiring reverse arthroplasty or massive irreparable rotator cuff tear, functional deltoid, as demonstrated on x-rays, MRI, and physical exam. Failed conservative management for \>3 months
Exclusion Criteria:
* younger than 18 years old
* chronic opiate use, fibromyalgia
* Rotator cuff repair patients - no previous rotator cuff repair surgery, no concomitant preoperative stiffness (definition: \< 30 degree passive external rotation, \< 100 degree passive forward elevation), no concomitant full-thickness subscapularis tear, no neurologic disorder affecting the ipsilateral upper extremity, no concomitant cervical pathology, partial thickness tear, large or massive tears (\>3cm in the anteroposterior dimension), glenohumeral or rotator cuff arthropathy, history of rheumatoid arthritis.
* Reverse total shoulder arthroplasty patients -no concomitant preoperative stiffness (definition: \< 30 degree passive external rotation, \< 100 degree passive forward elevation), no concomitant neurologic disorder affecting the ipsilateral upper extremity, no concomitant cervical pathology.
arthroplasty for fracture, revision surgery, insufficient bone stock requiring hemiarthroplasty, deltoid dysfunction, history of rheumatoid arthritis.
* prisoners
* non English speaking or unable to understand consent
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03488433
Study Brief:
Protocol Section:
NCT03488433