Rotator Cuff Tear
Conditions
Keywords
Rotator Cuff, Ultrasound, Pain, Tear Progression
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.
Interventions
None listed
Sponsors
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Washington University School of Medicine
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Shoulder Ultrasound & Radiographs | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder & Elbow Survey (ASES) | 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) |
| Western Ontario Rotator Cuff (WORC) Index | 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) |
| Short Form Health Survey (SF-12) | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Physical Examination by the study coordinator (Range of motion) | Through study completion, an average of 1 per year | Research team member measures shoulder range of motion using a goniometer. |
| Physical Examination by the study coordinator (Strength) | Through study completion, an average of 1 per year | Research team member measures shoulder strength measured with a dynamometer. |
Countries
United States
Outcome results
None listed