Subacromial Bursa Re-Implantation After Rotator Cuff Repair

NACompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

March 24, 2021

Primary Completion Date

October 30, 2024

Study Completion Date

April 2, 2025

Conditions
Rotator Cuff Injuries
Interventions
PROCEDURE

Experimental group(Bursa Implantation)

Prior to all rotator cuff repairs, a subacromial bursectomy is performed with an oscillating shaver so that the rotator cuff can be visualized and repaired.In the experimental group, instead of being discarded, this minced bursal tissue will be collected via a sterile filtration device attached to the oscillating shaver. The bursal tissue is then placed into a sterile syringe, and reimplanted back onto the bursal surface of the rotator cuff repair at the completion of the case. The arthroscopic fluid is turned off, and fluid is evacuated from the shoulder prior to reimplantation of the bursa.. Nothing is added to the bursa prior to reimplantation. There are no reagents. The bursa tissue is purely the minced bursa tissue removed from the patient, and never leaves the sterile field.

PROCEDURE

Control Group(Standard of Care)

Prior to all rotator cuff repairs, a subacromial bursectomy is performed with an oscillating shaver so that the rotator cuff can be visualized and repaired.The current standard of care procedure is to discard this tissue, and then proceed with the rotator cuff repair

Trial Locations (1)

77030

The University of Texas Health Science Center at Houston, Houston

All Listed Sponsors
lead

The University of Texas Health Science Center, Houston

OTHER

NCT04634084 - Subacromial Bursa Re-Implantation After Rotator Cuff Repair | Biotech Hunter | Biotech Hunter