The Natural History of Asymptomatic Rotator Cuff Tears
|ClinicalTrials.gov Identifier: NCT00923858|
Recruitment Status : Enrolling by invitation
First Posted : June 18, 2009
Last Update Posted : March 13, 2017
|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 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: Annually ]
- Patient completes ASES & MOS-26 [ Time Frame: Annually ]
- Physical Examination by the study coordinator [ Time Frame: Annually ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00923858
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Jay D Keener, MD||Washington University School of Medicine|