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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT01000935
Eligibility Criteria:
Inclusion criteria
1. Age \>18 years
2. Diagnosis of partial or full-thickness rotator cuff tear of less or equal to 3 cm. confirmed by MRI or US within a period of 6 months prior to booking surgery.
3. The final inclusion will be based on arthroscopic assessment of the tear size and lack of significant concurrent pathology.
Exclusion Criteria
1. Unable to speak or read English
2. Non-repairable tear
3. Acute tears (\<6 month)
4. Evidence of major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory arthropathy, frozen shoulder
5. Concurrent pathology of Superior Labral Anterior and Posterior (SLAP) lesions, Bankart lesions, or advanced osteoarthritis of the glenohumeral joint
6. Previous surgery of the affected shoulder
7. Bone marrow pathology
8. Abnormal platelet count
9. Serum hemoglobin concentration \<11 g/dL or hematocrit \<34%
10. Use of systemic cortisone
11. Current use of anticoagulants (i.e. Aspirin)
12. Use of an investigational drug and/or blood donation within the previous 3 months prior to surgery
13. Substance or alcohol abuse
14. Heavy smoking \[a daily cigarettes consumption of more than 20 pieces, based on definition of the World Health Organization (WHO)\]
15. Psychiatric illness that precludes informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01000935
Study Brief:
Protocol Section:
NCT01000935