The Natural History of Asymptomatic Rotator Cuff Tears

NCT ID: NCT00923858

Last Updated: 2022-08-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 495 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-07-01
• Study Completion Date: 2022-06-30

Brief Summary

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.

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.

Conditions

Rotator Cuff Tear

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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.

• 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.

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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay D Keener, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

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Other Identifiers

5R01AR051026

Identifier Type: NIH

Identifier Source: secondary_id

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IRB# 201103230

Identifier Type: -

Identifier Source: org_study_id