Subacromial Bursa Re-Implantation After Rotator Cuff Repair

Rotator Cuff Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04634084
• Other study ID #: HSC-MS-19-1092
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: September 22, 2024

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 22, 2024
• Est. primary completion date: September 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Number of participants with improvement in structural integrity as assessed by postoperative MRI		6 months post surgery
Secondary	Number of participants with improvement in structural integrity as assessed by postoperative MRI		12 months post surgery
Secondary	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
Secondary	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