Vascular Changes of Rotator Cuff Repair Augmented With a Whole Blood Fibrin Clot

Completed · Not applicable

Conditions studied: Rotator Cuff Tear

In brief

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.

Key facts

Study ID

NCT03577379

Run by

Santa Barbara Cottage Hospital

People needed

53

Starts

2019-03-01

Expected to finish

2022-04-25

Last updated by the study team

2022-05-05

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• De La Vina Surgery Center — Santa Barbara, California, United States

Full record on ClinicalTrials.gov

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