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 @ 11:49 PM
Ignite Modification Date:
2025-12-24 @ 11:49 PM
NCT ID:
NCT01586351
Eligibility Criteria:
Inclusion Criteria:
* Arthroscopic rotator cuff reconstructions of degenerative or traumatic full thickness rotatorcuff tears (supraspinatus should be affected)performed by Dr. Flury
* Age: 60 years or more
* Suture bridge technique
* Women: No longer of childbearing age (at menopause and last menstrual period more than 12 months, prevented surgically Ovaries and/or uterus removed surgically)
* Signed consent form
Exclusion Criteria:
* Partial reconstruction of the rotator cuff (PASTA)
* Open reconstruction
* Tendon transfer (latissimus dorsi or pectoralis major)
* Revision surgery
* Omarthrosis (Level ≥ 2 Samilson \& Prieto)
* Systemic arthritis
* Rheumatoid arthritis
* Diabetes (insulin treated)
* Requiring surgery in reconstruction of the subscapularis tendon
* Progressive fat inclusion (fatty infiltration of the rotator cuff musculature goutallier level IV
* Acute or chronic infection
* Pathological bone metabolism
* Insufficient perfusion in the affected arm
* Neuromuscular disease in the affected arm
* Non compliance of the patient
* Disorders which handicap or inhibit the patient to follow the orders of the clinical testers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT01586351
Study Brief:
Protocol Section:
NCT01586351