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 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT03001050
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of requiring Rotator Cuff repair surgical treatment
2. Willingness and ability to comply with the requirements of the protocol including follow-up requirements.
3. Willing and able to sign a study specific informed consent form to participate.
4. Age range of ≥ 30 years old and ≤ 80 years old at time of surgery.
5. Male or female.
Exclusion Criteria:
1. Previous Rotator cuff repair or shoulder surgery.
2. Active systemic infection or infection at the operative site.
3. Co-morbid medical conditions of the upper extremities that may affect the neurological and/or pain assessment.
4. History of an osteoporotic fracture.
5. History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism.
6. Taking medications that may interfere with bony/soft tissue healing including chronic steroid use.
7. Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia.
8. Insulin-dependent type 1 or type 2 diabetes.
9. Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion.
10. Pregnant, or intend to become pregnant, during the course of the study.
11. Severe obesity (Body Mass Index \> 40).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT03001050
Study Brief:
Protocol Section:
NCT03001050