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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT00664794
Eligibility Criteria:
Inclusion Criteria
* Age 18 years or older
* Diagnosis of full-thickness rotator cuff tear
* Ability to understand and adhere to rehab protocols and testing procedure
* Persistent pain and functional disability for at least 6 months and failure of 6 months of conservative treatment
Exclusion Criteria Preoperative
* Evidence of significant osteoarthritis or cartilage damage in the shoulder
* Evidence of glenohumeral instability including Bankart lesions and labral tears of any type
* Previous surgeries of the shoulder
* Evidence of major joint trauma, infection, or necrosis in the shoulder
* Patients with partial-thickness tears of the rotator cuff
* Patients unable to provide informed consent due to language barrier or mental status
* Patients with a major medical condition that would affect quality of life and influence the results of the study
* Patients with worker compensation claims
* Patients unwilling to be followed for the duration of the study.
Patient is automatically ineligible for study if 1 or more exclusion criteria is present.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00664794
Study Brief:
Protocol Section:
NCT00664794