Subacromial Bursa Re-Implantation After Rotator Cuff Repair

Study Overview
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Brief Summary
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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.

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

Conditions
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Rotator Cuff Injuries

Intervention / Treatment
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* Procedure: Experimental group(Bursa Implantation)
* Procedure: Control Group(Standard of Care)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br> | Procedure: Experimental group(Bursa Implantation)<br>* 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.<br>|
| Active Comparator: Control Group<br> | Procedure: Control Group(Standard of Care)<br>* 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<br>|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subacromial bursa