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Bursa Re-Implantation vs Standard Care for Rotator Cuff Repair

N/A
Waitlist Available
Led By James M Gregory, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Present with rotator cuff tears requiring arthroscopic repair as confirmed by a medical expert
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery
Awards & highlights

Study Summary

This trial is testing two different methods of rotator cuff repair to see which is better. One method involves adding an implant to the repair, and the other does not. The trial will compare outcomes, structural integrity, and tendon organization after the two different methods are used.

Who is the study for?
This trial is for individuals with rotator cuff tears confirmed by a medical expert, who can give informed consent and commit to follow-up visits. It excludes those unable to consent, with shoulder complications or infections, chronic inflammatory conditions like rheumatoid arthritis or lupus, recent corticosteroid injections in the shoulder, prior surgeries altering shoulder anatomy, or non-English speakers.Check my eligibility
What is being tested?
The study compares clinical outcomes of standard rotator cuff repair versus repair with subacromial bursa implantation. It also examines tendon structure using advanced UTE-MRI techniques at UT Health Science Center of Houston.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include pain at the surgery site, infection risk from the procedure itself, possible allergic reactions to materials used in bursa implantation if applicable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a rotator cuff tear that needs surgery, confirmed by a doctor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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 trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks after surgery,6 weeks after surgery,3 months after surgery,6 months after surgery,1 year after surgery,2 years after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in functional limitations of shoulder as measured by the Simple Shoulder Test(SST)
Change in pain as assessed by the Visual Analog Scale (VAS)
Elbow
+3 more
Secondary outcome measures
Number of participants with improvement in structural integrity as assessed by postoperative MRI
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.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental groupExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
912 Previous Clinical Trials
323,662 Total Patients Enrolled
1 Trials studying Rotator Cuff Tears
60 Patients Enrolled for Rotator Cuff Tears
James M Gregory, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
2 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

Control Group(Standard of Care) Clinical Trial Eligibility Overview. Trial Name: NCT04634084 — N/A
Rotator Cuff Tears Research Study Groups: Experimental group, Control Group
Rotator Cuff Tears Clinical Trial 2023: Control Group(Standard of Care) Highlights & Side Effects. Trial Name: NCT04634084 — N/A
Control Group(Standard of Care) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04634084 — N/A
~4 spots leftby Sep 2024
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