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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT06076902
Eligibility Criteria:
Inclusion Criteria:
* Adults with massive rotator cuff tear
* Tear must affect at least two tendons
* Primary surgery only
* Origin of tear can be either degenerative or traumatic
* German language speaking
Exclusion Criteria:
* Fatty infiltration grade 4 (according to Goutallier)
* Bilateral tears
* Cases of arthritis or severe osteoarthritis
* Structural or pathological condition of the bone or soft tissue that could impair healing
* Unable or unwilling to restrict activities to prescribed levels or follow rehabilitation guidelines
* Unable or unwilling to give consent (language barrier or cognitive impairment)
* Unwilling or unable to be assessed at 1- and 2-year follow-up assessment visits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT06076902
Study Brief:
Protocol Section:
NCT06076902