Subacromial Bursa Re-Implantation After Rotator Cuff Repair

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

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 Overview

• Status: Active, not recruiting
• Conditions: Rotator Cuff Injuries
• Intervention / Treatment: Procedure: Experimental group(Bursa Implantation); Procedure: Control Group(Standard of Care)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	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.
Active Comparator: Control Group	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: James M Gregory, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Estimated): September 22, 2024
• Study Completion (Estimated): September 22, 2024

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: subacromial bursa
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: HSC-MS-19-1092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No