Clinical trial NCT04634084: Subacromial Bursa Re-Implantation After Rotator Cuff Repair
Official title: Subacromial Bursa Re-Implantation After Rotator Cuff Repair - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injuries
Keywords: subacromial bursa
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 67
Sex: ALL
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in range of motion
timeFrame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
measure: Change in strength of shoulder
timeFrame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
measure: Change in pain of shoulder as measured by the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES)
timeFrame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
measure: Change in functional limitations of shoulder as measured by the Simple Shoulder Test(SST)
timeFrame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
measure: Change in pain as assessed by the Visual Analog Scale (VAS)
timeFrame: 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Tests (CATs)
timeFrame: 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 outcomes:
measure: Number of participants with improvement in structural integrity as assessed by postoperative MRI
timeFrame: 6 months post surgery
measure: Number of participants with improvement in structural integrity as assessed by postoperative MRI
timeFrame: 12 months post surgery
measure: 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.
timeFrame: 6 months post surgery
measure: 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.
timeFrame: 12 months post surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: James M Gregory, MD
role: PRINCIPAL_INVESTIGATOR
References: