Rotator Cuff Injuries
Conditions
Keywords
subacromial bursa
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.
Interventions
PROCEDUREExperimental 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.
PROCEDUREControl 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
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
25 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Tests (CATs) | 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 |
| Change in functional limitations of shoulder as measured by the Simple Shoulder Test(SST) | 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) |
| Change in pain as assessed by the Visual Analog Scale (VAS) | 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 |
| Change in range of motion | 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 |
| Change in strength of shoulder | 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 |
| Change in pain of shoulder as measured by the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 structural integrity as assessed by postoperative MRI | 6 months post surgery |
Countries
United States
Outcome results
None listed