Subacromial Bursa Re-Implantation After Rotator Cuff Repair

NCT04634084 | Completed DMC

• 1 other identifier: HSC-MS-19-1092
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

subacromial bursa

Outcome Measures

Primary Outcomes (6)

• Change in range of motion

  range of motion will be measured using a goniometer

  2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery

• Change in strength of shoulder

  shoulder strength will be measured using handheld dynamometer

  2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery

• Change in pain of shoulder as measured by the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)

  This is scored form 0-100,lower score means worse pain

  2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery

• Change in functional limitations of shoulder as measured by the Simple Shoulder Test(SST)

  The SST consists of 12 questions with dichotomous (yes/ no) response options. For each question, the patients indicate that they are able or are not able to do the activity. The scores range from 0 (worst) to 12(best)

  2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery

• Change in pain as assessed by the Visual Analog Scale (VAS)

  The VAS is scored form 0-10, 0 being no pain and 10 being worst pain

  2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery

• Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Tests (CATs)

  PROMIS CAT-PF is scored on a scale from 20-80, where a higher number indicates higher function

  2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery

Secondary Outcomes (4)

• Number of participants with improvement in structural integrity as assessed by postoperative MRI

  6 months post surgery

• Number of participants with improvement in structural integrity as assessed by postoperative MRI

  12 months post surgery

• Number of participants with improvement in tendon organization as assessed using quantitative postoperative ultrashort magnetic resonance imaging (UTE-MRI) using the same MRI scans from the 6- and 12-month time points.

  6 months post surgery

• Number of participants with improvement in tendon organization as assessed using quantitative postoperative ultrashort magnetic resonance imaging (UTE-MRI) using the same MRI scans from the 6- and 12-month time points.

  12 months post surgery

Study Arms (2)

Experimental group

EXPERIMENTAL

Procedure: Experimental group(Bursa Implantation)

Control Group

ACTIVE COMPARATOR

Procedure: Control Group(Standard of Care)

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.

Experimental group

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

Control Group

Eligibility Criteria

• Age: 25 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Gregory JM, Smith AZ, Zandiyeh P. Effect of Subacromial Bursa Augmentation on Self-Reported and Magnetic Resonance Imaging Outcomes in Arthroscopic Rotator Cuff Repair: A Prospective, Blinded Randomized Clinical Trial. Am J Sports Med. 2026 Jan 18:3635465251407328. doi: 10.1177/03635465251407328. Online ahead of print.

  PMID: 41549447 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• James M Gregory, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 18, 2020
• Study Start: March 24, 2021
• Primary Completion: October 30, 2024
• Study Completion: April 2, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)