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 @ 4:48 AM
Ignite Modification Date:
2025-12-25 @ 4:48 AM
NCT ID:
NCT01116518
Eligibility Criteria:
Inclusion Criteria:
1. age over 55 years
2. atraumatic penetrating supraspinatus tendon rupture comprising less than 2/3 of the tendon insertion and documented with MRI investigation.
3. full active range of motion
4. written informed consent from participating subject
Exclusion Criteria:
1. age under 55 years
2. existing significant malignant, haematological, endocrine, metabolic, rheumatoid or gastrointestinal disease
3. cytostatic or corticosteroid medication
4. glenohumeral osteoarthrosis grade III or above (X-ray evaluation with present osteophytes according to Kellgren-Lawrence classification)
5. history of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
6. previous same shoulder surgery
7. a massive tendon tear involving the whole supraspinatus tendon and/or combined tear of two - three tendons ie. supraspinatus with infraspinatus or subscapularis tendon tear.
8. patients denial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT01116518
Study Brief:
Protocol Section:
NCT01116518