A Pilot Cohort Study of Surgical and Non-surgical Management of 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.

Study Overview

• Status: Completed
• Conditions: Full Thickness Rotator Cuff Tear
• Intervention / Treatment: Procedure: Operative management

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.

• Study Type: Observational
• Enrollment (Actual): 222

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to an orthopaedic clinic with full-thickness rotator cuff tears as determined by surgeon opinion and imaging

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-operative; Patients whom elected non-operative treatment
Operative; Patients whom elected operative treatment	Procedure: Operative management; Rotator cuff surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Veterans Rand VR-12 Quality of Life Score	baseline
Veterans Rand VR-12 Quality of Life Score	4 weeks
Veterans Rand VR-12 Quality of Life Score	8 weeks
Veterans Rand VR-12 Quality of Life Score	16 weeks
Veterans Rand VR-12 Quality of Life Score	32 weeks
Veterans Rand VR-12 Quality of Life Score	48 weeks
Veterans Rand VR-12 Quality of Life Score	64 weeks

Collaborators and Investigators

• Sponsor: University of Michigan

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (Estimate): January 16, 2017

Study Record Updates

• Last Update Posted (Actual): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: HUM00056320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual patient data will be shared