Status:

COMPLETED

Features to Predict Success With Nonoperative Treatment of Patients With Rotator Cuff Tears

Lead Sponsor:

Vanderbilt University

Collaborating Sponsors:

University of Colorado, Denver

Ohio State University

Conditions:

Rotator Cuff Tear

Eligibility:

All Genders

18-100 years

Brief Summary

The goal of this study is to find which patients will improve with the nonsurgical treatment of physical therapy for the treatment of rotator cuff tears.

Detailed Description

Rotator cuff tears are found in up to 40% of people over the age of 50 with the prevalence increasing with age. While most people remain asymptomatic, it is unknown why some develop symptoms. In sympt...

Eligibility Criteria

Inclusion

  • • Patients (18-100 years of age) with MRI findings of a full-thickness rotator cuff tear
  • Note: Criteria to obtain a shoulder MRI to evaluate for rotator cuff tear \[Appendix D\]:
  • Significant weakness (≥ 2 points per guidelines above.)
  • ADL pain or night pain \>/= 7 on VAS
  • Significant impingement (per guidelines above) + with significant symptoms for ≥ 3 months.

Exclusion

  • Acute rotator cuff tears (generally due to a high velocity injury and symptoms of less than one month)
  • Associated dislocations
  • Associated fractures
  • Systemic Rheumatologic disease, i.e. Rheumatoid Arthritis and Systemic Lupus Erythematosis
  • Patients being treated for bilateral rotator cuff tears simultaneously
  • Patients unable to complete the forms
  • Pain from neck or scapula
  • Previous shoulder surgery
  • Glenohumeral arthritis (meets ≥ 1 of below criteria)
  • osteophytes \>2mm on humeral head or glenoid
  • Joint space narrowing with sclerosis or cyst formation seen on true AP or axillary radiographs;
  • humeral head contacting acromion
  • Adhesive capsulitis

Key Trial Info

Start Date :

January 1 2006

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

January 11 2024

Estimated Enrollment :

452 Patients enrolled

Trial Details

Trial ID

NCT00762580

Start Date

January 1 2006

End Date

January 11 2024

Last Update

January 16 2024

Active Locations (9)

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Page 1 of 3 (9 locations)

1

University of California at San Francisco

San Francisco, California, United States, 94143

2

Colorado University Sports Medicine

Boulder, Colorado, United States, 80304

3

Universtiy Of Iowa

Iowa City, Iowa, United States, 52242-1088

4

Department of Orthopaedic Surgery, Washington Universtiy School of Medicine

St Louis, Missouri, United States, 63110