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A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears

Full Thickness Rotator Cuff Tear Clinical Trial

Official title:
A Pilot Cohort Study of Surgical and Non-surgical Management of Rotator Cuff Tears

Clinical Trial Summary

This project will involve planning and implementing a two-arm prospective pragmatic cohort clinical trial in patients with known rotator cuff tears.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03021733
Study type Observational
Source University of Michigan
Contact
Status Completed
Phase N/A
Start date February 2012
Completion date November 2016
View Details
See also
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