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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT04057833
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 45-70 years old
* Diagnosis of full-thickness supraspinatus tendon tear by MRI and physical examination
* Tendon retraction 1 to 3 cm on MRI
* Goutallier score ≤ grade 2.
* Failed standard non-operative treatments for tendon tear including a minimum of 3 months of physical therapy as well as oral anti-inflammatory medications, subacromial steroid injection, activity modification, etc.
Exclusion Criteria:
* Tears of any cuff tendon other than the supraspinatus
* Frank signs of glenohumeral osteoarthritis on MRI
* Diagnosis of acute tendon tear
* Lack of significant pain and/or loss of function due to tendon tear History of previous rotator cuff repair
* History of upper extremity fracture or other moderate to severe upper extremity trauma
* BMI \< 20 or \> 35
* Diagnosis of Type I or type II diabetes, or other metabolic disorders
* Previous history of cancer. Subjects with cervical carcinoma in situ or localized basal or squamous cell carcinoma treated with definitive surgery are eligible.
* Diagnosis of an autoimmune disorder Know history of HIV
* Current use of nicotine products
* History of diabetes, malignancy within 5 years of the procedure, immunosuppression, autoimmune or connective tissue disorders such as lupus or rheumatoid arthritis, schizophrenia or other psychiatric disorder that could interfere with postoperative rehabilitation, or other disability that would obviously adversely impact the patient's ability to participate in standard postoperative rehabilitation
* Pregnancy
* Inability to comply with post-operative rehabilitation
* Hypersensitivity reactions to bovine (cow) proteins
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT04057833
Study Brief:
Protocol Section:
NCT04057833