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

NCT ID: NCT03021733

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Full Thickness Rotator Cuff Tear

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-operative

Patients whom elected non-operative treatment

No interventions assigned to this group

Operative

Patients whom elected operative treatment

Operative management

Intervention Type PROCEDURE

Rotator cuff surgery

Interventions

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Operative management

Rotator cuff surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Joel Gagnier

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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HUM00056320

Identifier Type: -

Identifier Source: org_study_id