Status:
COMPLETED
The Natural History of Asymptomatic Rotator Cuff Tears
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Rotator Cuff Tear
Eligibility:
All Genders
18-75 years
Brief Summary
The purpose of this project is to provide information which can help us understand what happens over time to rotator cuff tears. In this study, the investigators will follow a population of people wit...
Detailed Description
The specific aims of our study are: 1. To determine the probability that an asymptomatic rotator cuff tear will become symptomatic over time. 2. To determine which epidemiological factors correlate w...
Eligibility Criteria
Inclusion
- Group 1 (Cohorts I \& II)
- 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
- 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)
Key Trial Info
Start Date :
July 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
495 Patients enrolled
Trial Details
Trial ID
NCT00923858
Start Date
July 1 2005
End Date
June 1 2022
Last Update
August 31 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110