Subacromial Bursa Re-Implantation After Rotator Cuff Repair

• ClinicalTrials.gov Identifier: NCT04634084
• Recruitment Status: Recruiting
• First Posted: November 18, 2020
• Last Update Posted: May 24, 2021
• Sponsor: The University of Texas Health Science Center, Houston
• Information provided by (Responsible Party): James M. Gregory, The University of Texas Health Science Center, Houston

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rotator Cuff Injuries	Procedure: Experimental group(Bursa Implantation); Procedure: Control Group(Standard of Care)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Subacromial Bursa Re-Implantation After Rotator Cuff Repair - A Randomized Controlled Trial
• Actual Study Start Date: March 24, 2021
• Estimated Primary Completion Date: July 1, 2022
• Estimated Study Completion Date: February 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in range of motion [ Time Frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery ]
   range of motion will be measured using a goniometer
2. Change in strength of shoulder [ Time Frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery ]
   shoulder strength will be measured using handheld dynamometer
3. Change in pain of shoulder as measured by the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) [ Time Frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery ]
   This is scored form 0-100,lower score means worse pain
4. Change in functional limitations of shoulder as measured by the Simple Shoulder Test(SST) [ Time Frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery ]
   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)
5. Change in pain as assessed by the Visual Analog Scale (VAS) [ Time Frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery ]
   The VAS is scored form 0-10, 0 being no pain and 10 being worst pain
6. Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Tests (CATs) [ Time Frame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery ]
   PROMIS CAT-PF is scored on a scale from 20-80, where a higher number indicates higher function

Secondary Outcome Measures :

1. Number of participants with improvement in structural integrity as assessed by postoperative MRI [ Time Frame: 6 months post surgery ]
2. Number of participants with improvement in structural integrity as assessed by postoperative MRI [ Time Frame: 12 months post surgery ]
3. 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. [ Time Frame: 6 months post surgery ]
4. 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. [ Time Frame: 12 months post surgery ]

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Ryan Warth, MD; (713) 486-7500; ryan.j.warth@uth.tmc.edu

Contact: Natasha E Howard; (713) 486-5521; Natasha.E.Howard@uth.tmc.edu

Locations

United States, Texas

The University of Texas Health Science Center at Houston; Recruiting

Houston, Texas, United States, 77030

Contact: James M Gregory, MD 713-486-7500 James.M.Gregory@uth.tmc.edu

Contact: Natasha E Howard (713) 486-5521 Natasha.E.Howard@uth.tmc.edu

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

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

More Information

• Responsible Party: James M. Gregory, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT04634084
• Other Study ID Numbers: HSC-MS-19-1092
• First Posted: November 18, 2020
• Last Update Posted: May 24, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James M. Gregory, The University of Texas Health Science Center, Houston:

subacromial bursa

Additional relevant MeSH terms:

Rotator Cuff Injuries; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries