Vascular Changes of Rotator Cuff Repair Augmented With a Whole Blood Fibrin Clot (NCT03577379) | Clinical Trial Compass
CompletedNot Applicable
Vascular Changes of Rotator Cuff Repair Augmented With a Whole Blood Fibrin Clot
United States53 participantsStarted 2019-03-01
Plain-language summary
The goal of this study is to assess whether undergoing surgical repair of the rotator cuff with the additional intervention of whole blood fibrin clot will improve rotator cuff vascularization at the bone-tendon interface repair site and patient outcomes compared to those who do not receive the whole blood fibrin clot intervention.
Who can participate
Age range18 Years – 69 Years
SexALL
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Inclusion Criteria:
1\) Presence of ultrasonographic or magnetic resonance imaging (MRI) documented rotator cuff tear confirmed at surgery to be a medium to large-sized rotator cuff tear (\> 1 cm), which requires intervention due to persistent difficulty in elevation of affected shoulder and/or pain; 2) ability to give informed consent for procedure, rehabilitation, and regular clinical and radiologic follow-up for a minimum period of 6 most post-surgery; and have 3) preoperative blood platelet counts \>150,000/microliter.
Exclusion Criteria:
1\) they have a type III subscapularis tear and above due to different rehabilitation protocol; 2) massive, partial, or traumatic cuff tears; 3) partial or incomplete repairs; 4) is a chronic smoker or patient with Parkinson's disease; 5) have a condition that may hinder healing or attending follow-up visits (e.g., diabetes, immunocompromised status, chemotherapy treatment, chronic steroid use); and 6) age \>70.