NCT04634084

Subacromial Bursa Re-Implantation After Rotator Cuff Repair

Subacromial Bursa Re-Implantation After Rotator Cuff Repair - A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 25 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate clinical outcomes, structural integrity, and tendon organization after rotator cuff repair with and without subacromial bursa implantation and to further co-existing research studies performed at The University Of Texas Health Science Center of Houston (UT Health) on Ultrashort Time to Echo-Magnetic Imaging Resonance(UTE-MRI) techniques and their implication for rotator cuff analysis.

Conditions

• Rotator Cuff Injuries

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-03-24
• Primary completion: 2024-10-30
• Completion: 2025-04-02
• First posted: 2020-11-18
• Last updated: 2025-06-17

Locations

1 site across 1 country: United States