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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental |
| |
| Control Group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental group(Bursa Implantation) | Procedure | 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. |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James M Gregory, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41549447 | Derived | Gregory JM, Smith AZ, Zandiyeh P. Effect of Subacromial Bursa Augmentation on Self-Reported and Magnetic Resonance Imaging Outcomes in Arthroscopic Rotator Cuff Repair: A Prospective, Blinded Randomized Clinical Trial. Am J Sports Med. 2026 Mar;54(4):848-856. doi: 10.1177/03635465251407328. Epub 2026 Jan 18. |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| Control Group(Standard of Care) | Procedure | 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 |
|
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 |
| 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 |