Full Thickness Rotator Cuff Tear
Conditions
Brief summary
This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears.
Detailed description
This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears. Pragmatic or effectiveness clinical trials reflect real world settings and thus have greater external generalizability than efficacy trials. The evaluation component in this trial will be three-fold: first, the study team will compare the success of patients undergoing operative versus non-operative management and identify which variables predict success in each group; second, investigators will attempt to predict which patients end up choosing, along with their care giver(s), operative versus non-operative management by examining the predictive capability of a selection of variables; third, investigators will evaluate the clinical research site(s), personnel, and implementation processes for their capability to implement clinical trials with the intent of planning for a future large multi-site clinical trial building on the results of the present study.
Interventions
PROCEDUREOperative management
Rotator cuff surgery
Sponsors
University of Michigan
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Veterans Rand VR-12 Quality of Life Score | baseline |
Outcome results
None listed