The Natural History of Asymptomatic Rotator Cuff Tears

August 29, 2022 updated by: Washington University School of Medicine

Asymptomatic Cuff Tears: A Model for Pain Development - Part B

The purpose of this project is to provide information which can help us understand what happens over time to rotator cuff tears. In this study, the investigators will follow a population of people with rotator cuff tears that do not hurt (asymptomatic) and to establish the probability that an asymptomatic rotator cuff tear, identified in the context of contralateral symptoms, will become symptomatic over time. To determine with ultrasound the probability that a rotator cuff tear will enlarge over time. To determine if symptom progression correlates with enlargement of the rotator cuff tear and/or degenerative changes on radiographs. In order to obtain data, study subjects will be recalled for follow-up at 1 year time points over a 5 year period. The study subjects will have repeat physical exam, ultrasound and radiographic examinations. A control group of normal patients will also be followed for comparison.

Study Overview

Status

Completed

Conditions

Detailed Description

The specific aims of our study are:

  1. To determine the probability that an asymptomatic rotator cuff tear will become symptomatic over time.
  2. To determine which epidemiological factors correlate with symptomatic progression.
  3. To determine if symptomatic progression correlates with enlargement of the rotator cuff tear as determined at sonography.
  4. To determine the value of routine sonographic scanning of the asymptomatic shoulder.

Study Type

Observational

Enrollment (Actual)

495

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients are recruited from orthopaedic surgeon's clinic.

Description

Group 1 (Cohorts I & II) Inclusion Criteria:

  • Participants who enrolled at age 65 years or younger will remain in the study.
  • Less than 11 annual visits of non-operative surveillance of study shoulder.
  • Less than 3 annual visits following a rotator cuff repair of study shoulder.

Group 1 (Cohorts I & II) Exclusion Criteria:

  • Workman's Compensation claim involving the shoulders.
  • Use of crutch, cane or weight-bearing device on study shoulder.
  • Moderate or severe glenohumeral arthritis.
  • Inflammatory or other disease process affecting neurological/musculoskeletal systems that may impact weight-bearing activities or normal use of upper body.
  • Inability to return for routine study visits.
  • Traumatic injury to rotator cuff.
  • Rotator Cuff Tear greater than 30mm in width.
  • Advanced fatty muscle degeneration.

Patients who are currently enrolled but require a shoulder replacement will not remain in the study. Cohorts I & II will now be considered the control group for comparison to those enrolled in this next recruitment period.

Group 2 (Cohort III) Inclusion Criteria:

  • Age 65 years or younger.
  • Surgical candidate for primary, double-row repair of a rotator.
  • Able to comply with post operative therapy protocol.
  • Bilateral partial or full thickness rotator cuff tears: one symptomatic requiring surgery and the contralateral shoulder asymptomatic.

Group 2 (Cohort III) Exclusion Criteria:

  • Workman's Compensation claim involving the shoulders.
  • Use of crutch, cane or weight-bearing device on study shoulder.
  • Moderate or severe glenohumeral arthritis.
  • Inflammatory or other disease process affecting neurological/musculoskeletal systems that may impact weight-bearing activities or normal use of upper body.
  • Inability to return for routine study visits.
  • Traumatic injury to rotator cuff.
  • Rotator Cuff Tear greater than 30mm in width.
  • Advanced fatty muscle degeneration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Control - participants from cycles 1 & 2
no intervention. Control group is composed of participants from Cohort I (recruited during our first grant cycle) and from Cohort II (recruited during our second grant cycle). Continued observation is planned for those controls, partial tears and full tears who enrolled in study at age 65 years or younger and have less than 11 years of follow up.
Cuff Tear Cohort III
These participants are being recruited from our clinical population and have been scheduled to undergo a standard of care rotator cuff repair and post op therapy. One shoulder has been indicated for rotator cuff repair and the contralateral shoulder is asymptomatic. Both shoulders will be monitored.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized Shoulder Ultrasound & Radiographs
Time Frame: Through study completion, an average of 1 per year
The ultrasound involves measurement of rotator cuff tear (if present) and assessment of muscle degeneration. Radiographs will be used to document any bony changes.
Through study completion, an average of 1 per year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
American Shoulder & Elbow Survey (ASES)
Time Frame: Through study completion, an average of 1 per year
Assessment of patient-rated shoulder pain and function/disability. Questions involve activities of daily living that reflect the use of the shoulder & elbow in different planes of motion. Pain and weakness with various activities are also addressed. (Range 0-100, higher scores indicate better outcomes)
Through study completion, an average of 1 per year
Western Ontario Rotator Cuff (WORC) Index
Time Frame: Through study completion, an average of 1 per year
Disease-specific quality of life questionnaire, evaluating the change in symptoms and functional ability, specific to rotator cuff tendinopathy. (Range: 0-2100, normalized to 0-100, higher scores indicate worst possible symptoms)
Through study completion, an average of 1 per year
Short Form Health Survey (SF-12)
Time Frame: Through study completion, an average of 1 per year
General health assessment composed of two scales, Physical Component Summary and Mental Component Summary (Range: 0-100, higher scores indicate better health)
Through study completion, an average of 1 per year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Examination by the study coordinator (Range of motion)
Time Frame: Through study completion, an average of 1 per year
Research team member measures shoulder range of motion using a goniometer.
Through study completion, an average of 1 per year
Physical Examination by the study coordinator (Strength)
Time Frame: Through study completion, an average of 1 per year
Research team member measures shoulder strength measured with a dynamometer.
Through study completion, an average of 1 per year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Jay D Keener, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2005

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

June 16, 2009

First Submitted That Met QC Criteria

June 17, 2009

First Posted (Estimate)

June 18, 2009

Study Record Updates

Last Update Posted (Actual)

August 31, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB# 201103230
  • 5R01AR051026 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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