Full Thickness Rotator Cuff Tear Clinical Trial
Official title:
A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears
Verified date | September 2017 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears.
Status | Completed |
Enrollment | 222 |
Est. completion date | November 2016 |
Est. primary completion date | November 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Patients over 18 years of age with full-thickness rotator cuff tears eligible for operative repair Exclusion Criteria: - less than 18 years old, - non-operative rotator cuff tears, - calcific tendonitis, fracture, adhesive capsulitis, - severe osteoarthritis of the shoulder, - no prior shoulder surgery |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Veterans Rand VR-12 Quality of Life Score | baseline | ||
Primary | Veterans Rand VR-12 Quality of Life Score | 4 weeks | ||
Primary | Veterans Rand VR-12 Quality of Life Score | 8 weeks | ||
Primary | Veterans Rand VR-12 Quality of Life Score | 16 weeks | ||
Primary | Veterans Rand VR-12 Quality of Life Score | 32 weeks | ||
Primary | Veterans Rand VR-12 Quality of Life Score | 48 weeks | ||
Primary | Veterans Rand VR-12 Quality of Life Score | 64 weeks |
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