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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT00923858
Eligibility Criteria:
Group 1 (Cohorts I \& II) Inclusion Criteria:
* Participants who enrolled at age 65 years or younger will remain in the study.
* Less than 11 annual visits of non-operative surveillance of study shoulder.
* Less than 3 annual visits following a rotator cuff repair of study shoulder.
Group 1 (Cohorts I \& II) Exclusion Criteria:
* Workman's Compensation claim involving the shoulders.
* Use of crutch, cane or weight-bearing device on study shoulder.
* Moderate or severe glenohumeral arthritis.
* Inflammatory or other disease process affecting neurological/musculoskeletal systems that may impact weight-bearing activities or normal use of upper body.
* Inability to return for routine study visits.
* Traumatic injury to rotator cuff.
* Rotator Cuff Tear greater than 30mm in width.
* Advanced fatty muscle degeneration.
Patients who are currently enrolled but require a shoulder replacement will not remain in the study. Cohorts I \& II will now be considered the control group for comparison to those enrolled in this next recruitment period.
Group 2 (Cohort III) Inclusion Criteria:
* Age 65 years or younger.
* Surgical candidate for primary, double-row repair of a rotator.
* Able to comply with post operative therapy protocol.
* Bilateral partial or full thickness rotator cuff tears: one symptomatic requiring surgery and the contralateral shoulder asymptomatic.
Group 2 (Cohort III) Exclusion Criteria:
* Workman's Compensation claim involving the shoulders.
* Use of crutch, cane or weight-bearing device on study shoulder.
* Moderate or severe glenohumeral arthritis.
* Inflammatory or other disease process affecting neurological/musculoskeletal systems that may impact weight-bearing activities or normal use of upper body.
* Inability to return for routine study visits.
* Traumatic injury to rotator cuff.
* Rotator Cuff Tear greater than 30mm in width.
* Advanced fatty muscle degeneration.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00923858
Study Brief:
Protocol Section:
NCT00923858