The Natural History of Asymptomatic Rotator Cuff Tears

The Washington University

Status: Completed

Conditions: Rotator Cuff Tear

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00923858

5R01AR051026 (U.S. NIH Grant/Contract)

IRB# 201103230

Details and patient eligibility

About

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.

Full 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.

Enrollment: 495 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

495 participants in 2 patient groups

Control - participants from cycles 1 & 2

Description:

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

Description:

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.