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

NCT00762580 | Completed DMC

• 1 other identifier: 060109
• Study Type: observational
• Target: 452
• Locations: 1 country
• Sites: 9

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.

Conditions

Rotator Cuff Tear

Keywords

rotator cuff; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Predict successful outcome with an evidence-based, non-operative treatment program by collecting VAS Pain Scale and SANE score.

  One year

Secondary Outcomes (1)

• Predict success of non-operative treatment outcomes with other patient related validated instruments (SF-12, ASES, WORC, Marx Activity Scale)

  One Year

Study Arms (1)

Prospective

Patients with full thickness rotator cuff tears being treated with physical therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults between the ages of 18-100 with full thickness rotator cuff tears.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• University of Colorado, Denver: collaborator
• Ohio State University: collaborator
• University of Iowa: collaborator
• University of California, San Francisco: collaborator
• Arthrex, Inc.: collaborator
• Knoxville Orthopedic Clinic: collaborator
• Washington University School of Medicine: collaborator
• Sports Medicine and Shoulder Surgery Orthopedic Institute: collaborator
• Hospital for Special Surgery, New York: collaborator

Study Sites (9)

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Colorado University Sports Medicine

Boulder, Colorado, 80304, United States

Location

Universtiy Of Iowa

Iowa City, Iowa, 52242-1088, United States

Location

Department of Orthopaedic Surgery, Washington Universtiy School of Medicine

St Louis, Missouri, 63110, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Ohio State

Columbus, Ohio, 43221-3502, United States

Location

Sports Medicine & Shoulder Surgery, Orthopedic Institute

Sioux Falls, South Dakota, 57117, United States

Location

Shoulder and Elbow Institute, Knoxville Orthopaedic Clinic

Knoxville, Tennessee, 37922, United States

Location

Vanderbilt Universtiy Medical Center

Nashville, Tennessee, 37232, United States

Location

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MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• John E. Kuhn, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: January 1, 2006
• Primary Completion: January 11, 2024
• Study Completion: January 11, 2024
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

US (9)