The Natural History of Asymptomatic Rotator Cuff Tears
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/17/2018 |
| Start Date: | July 2005 |
| End Date: | July 2021 |
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.
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.
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.
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.
Group 1 (Cohorts I & II) Inclusion:
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:
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:
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:
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.
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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