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:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-24 @ 4:20 PM
NCT ID:
NCT04361266
Eligibility Criteria:
Inclusion Criteria:
* -symptomatic supraspinatus or supraspinatus and infraspinatus tear that can be repaired to the greater tuberosity in an anatomical manner using a dual layer repair technique.
* also included will be patients that have concomitant pathology addressed at time of surgery, specifically pathologies of the biceps tendon (tenodesis or tenotomy), arthrosis of the acromioclavicular joint (distal clavicle resection), or labral tearing (debridement or repair)
* included age range of subjects will be from 18-80 years old
Exclusion Criteria:
* diabetes, cancer or medical states that may impair healing, such as organ transplantation or systemic inflammatory process treated with immune modulating drugs (chemotherapy, immunosuppression drugs)
* prior surgery to the ipsilateral rotator cuff tendon
* need of soft tissue releases to accomplish an anatomic repair, partial repairs and/or concomitant subscapularis repair
* significant glenohumeral arthritis
* active or ongoing infection
* pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04361266
Study Brief:
Protocol Section:
NCT04361266