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 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT06984068
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients aged between 40 and 70 years.
2. Clinically and radiologically (magnetic resonance imaging) diagnosed full-thickness supraspinatus tendon tears that were confirmed by arthroscopic surgery and could be surgically repaired.
3. Degree of supraspinatus tendon tear according to the DeOrio and Cofield grading system as moderate tear (1-3 cm) and mild tear (\<1 cm).
4. Serum vitamin D level \<30 ng/mL \>20 ng/mL before rotator cuff tears surgery
5. Signed informed consent and underwent 12-month follow-up.
Exclusion Criteria:
1. Presence of other shoulder pathologies such as subscapularis tear, adhesive capsulitis, long head of biceps tendonitis, calcific tendonitis, or shoulder tumor.
2. Large or unrepairable rotator cuff tear (\>3 cm).
3. Previous history of shoulder surgery or recurrent rotator cuff tears.
4. Combined injury to the shoulder labrum, articular cartilage or biceps tendon.
5. Contraindications to vitamin D supplementation (e.g., allergies).
6. Serious comorbidities such as cardiovascular disease.
7. Severe osteoporosis or rheumatoid arthritis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT06984068
Study Brief:
Protocol Section:
NCT06984068