Subacromial Bursa Re-Implantation After Rotator Cuff Repair

The University of Texas Health Science Center, Houston67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Rotator Cuff Injuries

Interventions

Experimental group(Bursa Implantation)PROCEDURE

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.

Control Group(Standard of Care)PROCEDURE

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

Eligibility

Sex: ALLMin age: 25 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Present with rotator cuff tears requiring arthroscopic repair as confirmed by a medical expert * Are able to provide informed consent * Can commit to study follow-up visits or procedures Exclusion Criteria: * Are unable to provide informed consent * Have additional ipsilateral shoulder complications that will inhibit standard of care treatment and rehabilitation * Have active infection at operative site * Have active systemic infection * Chronic inflammatory condition such as rheumatoid arthritis or lupus * Has had a corticosteroid injection to the affected shoulder within the six weeks prior to surgery * Have had prior surgical interventions in the past that have modified the existing natural anatomical arrangement of the rotator cuff/shoulder. * Non-English speaker

Locations (1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States