The Natural History of Asymptomatic Rotator Cuff Tears
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.
Rotator Cuff Tear
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Asymptomatic Cuff Tears: A Model for Pain Development - Part B|
- Standardized Shoulder Ultrasound & Radiographs [ Time Frame: Annually ] [ Designated as safety issue: No ]
- Patient completes ASES & MOS-26 [ Time Frame: Annually ] [ Designated as safety issue: No ]
- Physical Examination by the study coordinator [ Time Frame: Annually ] [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
Partial Thickness Tear
Full Thickness Tear
No Tear - Control Group
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923858
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Ken Yamaguchi, MD||Washington University School of Medicine|