Subacromial Bursa Re-Implantation After Rotator Cuff Repair
- Conditions
- Rotator Cuff Injuries
- Interventions
- Procedure: Experimental group(Bursa Implantation)Procedure: Control Group(Standard of Care)
- Registration Number
- NCT04634084
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Experimental group(Bursa Implantation) - Control Group Control Group(Standard of Care) -
- Primary Outcome Measures
Name Time Method 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 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 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
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
- Secondary Outcome Measures
Name Time Method 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 Number of participants with improvement in structural integrity as assessed by postoperative MRI 12 months post surgery
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States