The Natural History of Asymptomatic Rotator Cuff Tears
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|ClinicalTrials.gov Identifier: NCT00923858|
Recruitment Status : Active, not recruiting
First Posted : June 18, 2009
Last Update Posted : April 14, 2020
|Condition or disease|
|Rotator Cuff Tear|
The specific aims of our study are:
- To determine the probability that an asymptomatic rotator cuff tear will become symptomatic over time.
- To determine which epidemiological factors correlate with symptomatic progression.
- To determine if symptomatic progression correlates with enlargement of the rotator cuff tear as determined at sonography.
- To determine the value of routine sonographic scanning of the asymptomatic shoulder.
|Study Type :||Observational|
|Estimated Enrollment :||550 participants|
|Official Title:||Asymptomatic Cuff Tears: A Model for Pain Development - Part B|
|Study Start Date :||July 1, 2005|
|Estimated Primary Completion Date :||May 2021|
|Estimated Study Completion Date :||July 2021|
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.
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.
- Standardized Shoulder Ultrasound & Radiographs [ Time Frame: 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.
- American Shoulder & Elbow Survey (ASES) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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)
- Physical Examination by the study coordinator (Range of motion) [ Time Frame: 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) [ Time Frame: Through study completion, an average of 1 per year ]Research team member measures shoulder strength measured with a dyanometer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923858
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Jay D Keener, MD||Washington University School of Medicine|