Rotator Cuff Failure With Continuity
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|ClinicalTrials.gov Identifier: NCT02716441|
Recruitment Status : Recruiting
First Posted : March 23, 2016
Last Update Posted : February 17, 2020
|Condition or disease||Intervention/treatment|
|Rotator Cuff Tear||Device: Radio-opaque Tissue Markers|
Currently, rotator cuff healing is defined as "intact", "attenuated", or "failed" based on the observation (or not) of a recurrent defect (i.e., a "gap") in the tendon using MRI or ultrasound imaging. The investigators' previous work has identified a new outcome, in which there is no detectable defect or "gap" in the repaired tendon, but the repaired tendon has undergone significant retraction. The investigators call this outcome "failure with continuity".
Current imaging methods are inadequate to determine the extent to which the repaired rotator cuff tendon has "failed with continuity". The investigators have developed an imaging technique to detect this phenomenon. Specifically, radio-opaque markers are sutured onto the repaired tendon. The distance between the tendon markers and the bone is measured from CT scans taken within 2 weeks of surgery, and compared to the distance measured at 3, 6, 12 and 24 months. If the tendon retracts away from the bone during healing, this distance will increase over time. Healing of the tendon will also be monitored in the traditional manner by MRI scans at the same time points. The investigators will investigate the relationship between tendon retraction, MR imaging and clinical outcomes including shoulder strength and patient satisfaction.
The investigators expect to show that tendon retraction is common, occurs early post-operatively, with or without repair continuity as assessed by traditional imaging, and significantly correlates with clinical outcomes. The immediate and highly significant consequence of this finding would be a paradigm shift in the investigators' understanding of tendon repair healing, now incorporating the magnitude, timing and location of tendon retraction as well as the continuity of the repaired tissue. This information would yield a more precise understanding of rotator cuff tendon healing, allowing for advances in treatment strategies that improve surgical healing and clinical outcomes and result in more durable rotator cuff repairs over time.
|Study Type :||Observational|
|Estimated Enrollment :||125 participants|
|Official Title:||Failure With Continuity and Its Relation to Rotator Cuff Repair Clinical Outcomes|
|Actual Study Start Date :||September 2016|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2023|
Radio-opaque Tissue Markers
Patients undergoing rotator cuff repair with implantation of radio-opaque tissue markers
Device: Radio-opaque Tissue Markers
All participants will undergo implantation of radio-opaque tissue markers on their repaired rotator cuff at the time of surgery.
- Change in Tendon Retraction [ Time Frame: Day of surgery, 24 months following rotator cuff repair ]Medial translation of the repaired tendon away from the bone between the day of surgery and 24 months following rotator cuff repair as measured by CT imaging of radio-opaque markers implanted on the tendon.
- Change in Shoulder Strength [ Time Frame: Day of surgery, 24 months following rotator cuff repair ]Isometric shoulder strength will be measured using a dynamometer.
- Change in American Shoulder and Elbow Society (ASES) Score [ Time Frame: Day of surgery, 24 months following rotator cuff repair ]Patient reported outcome measure
- Change in Pennsylvania Shoulder Score (PSS) [ Time Frame: Day of surgery, 24 months following rotator cuff repair ]Patient reported outcome measure
- Tendon Integrity [ Time Frame: 24 months following rotator cuff repair ]Traditional assessment of tendon repair integrity will be performed by MR imaging
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): NCT02716441
|Contact: Cathy Shemoemail@example.com|
|United States, Ohio|
|Cleveland Clinic Main Campus||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Cathy Shemo, BS 216-444-5971 firstname.lastname@example.org|
|Principal Investigator:||Kathleen Derwin, PhD||The Cleveland Clinic|