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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00762580
Recruitment Status : Active, not recruiting
First Posted : September 30, 2008
Last Update Posted : February 6, 2020
Sponsor:
Collaborators:
University of Colorado, Denver
Ohio State University
University of Iowa
University of California, San Francisco
Arthrex, Inc.
Knoxville Orthopedic Clinic
Washington University School of Medicine
Sports Medicine and Shoulder Surgery Orthopedic Institute
Hospital for Special Surgery, New York
Information provided by (Responsible Party):
Rosemary A. Sanders, Vanderbilt University

Tracking Information
First Submitted Date September 26, 2008
First Posted Date September 30, 2008
Last Update Posted Date February 6, 2020
Study Start Date January 2006
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 26, 2008)
Predict successful outcome with an evidence-based, non-operative treatment program by collecting VAS Pain Scale and SANE score. [ Time Frame: One year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 26, 2008)
Predict success of non-operative treatment outcomes with other patient related validated instruments (SF-12, ASES, WORC, Marx Activity Scale) [ Time Frame: One Year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Features to Predict Success With Nonoperative Treatment of Patients With Rotator Cuff Tears
Official Title Features to Predict Success With Nonoperative Treatment of Patients With Rotator Cuff Tears
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 symptomatic patients, surgical repair of a torn rotator cuff fails in 30-50% of patients, yet the majority of patients have a significant reduction pain despite failure of the repair. Nonoperative treatment has reported successful outcomes in 25-82% of patients yet it is not known which patient-related features predict success with nonoperative treatment. The general aim of this research effort is to identify patient features (historical information, physical examination findings, and MRI-based pathology) that would predict success (defined by reduction in visual analog pain scale, and patient satisfaction) with the nonoperative treatment of rotator cuff tears. The proposed study design is a prospective cohort study of patients with rotator cuff tears who will follow a standard physical therapy program derived from an evidence based medicine (EBM) systematic review of Level 1 and Level 2 studies.

Study the effect of historical information on predicting success (as determined by pain relief and patient satisfaction) of nonoperative treatment using the EBM based physical therapy program in treating patients with rotator cuff tears.

Study the effect of physical examination findings on predicting success of a nonoperative treatment using the EBM-based physical therapy program in treating patients with rotator cuff tears.

Study the effect of the severity of the rotator cuff pathology (using standardized magnetic resonance imaging protocols) on predicting success of nonoperative treatment for patients with rotator cuff tears using the EBM-based physical therapy program.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults between the ages of 18-100 with full thickness rotator cuff tears.
Condition Rotator Cuff Tear
Intervention Not Provided
Study Groups/Cohorts Prospective
Patients with full thickness rotator cuff tears being treated with physical therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: January 24, 2018)
452
Original Estimated Enrollment
 (submitted: September 26, 2008)
380
Estimated Study Completion Date January 2023
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

• 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]:

  1. Significant weakness (≥ 2 points per guidelines above.)
  2. ADL pain or night pain >/= 7 on VAS
  3. Significant impingement (per guidelines above) + with significant symptoms for ≥ 3 months.

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00762580
Other Study ID Numbers 060109
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: De Identified data from this cohort is only available to members of the MOON Shoulder Consortium. The member must provide a description of the use of the data to the research coordinator. The data request is then presented to the MOON consortium. A unanimous agreement of the plan by the consortium must be received prior to receiving the data.
Responsible Party Rosemary A. Sanders, Vanderbilt University
Study Sponsor Vanderbilt University
Collaborators
  • University of Colorado, Denver
  • Ohio State University
  • University of Iowa
  • University of California, San Francisco
  • Arthrex, Inc.
  • Knoxville Orthopedic Clinic
  • Washington University School of Medicine
  • Sports Medicine and Shoulder Surgery Orthopedic Institute
  • Hospital for Special Surgery, New York
Investigators
Principal Investigator: John E. Kuhn, MD Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date February 2020