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

University of Michigan222 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

222

Conditions

Full Thickness Rotator Cuff Tear

Interventions

Operative managementPROCEDURE

Rotator cuff surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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