The Natural History of Asymptomatic Rotator Cuff Tears
- Conditions
- Rotator Cuff Tear
- Registration Number
- NCT00923858
- Lead Sponsor
- Washington University School of Medicine
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 495
- 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)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
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)
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States