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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 weeks3 visits

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

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

903 Previous Clinical Trials

320,964 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial extend its enrollment to adults of all ages?

"The study's inclusion criteria dictates that applicants must be between 25 and 90 years of age. There are a total of 104 trials available, 10 for minors and 94 for individuals over 65."

Answered by AI

Is enrollment for this trial currently open?

"According to clinicaltrials.gov, this medical trial has concluded its recruitment process after first launching on March 24th 2021 and last updated October 31st 2022. However, 105 other trials are still actively seeking participants at present."

Answered by AI

Is enrollment for this medical experiment still taking place?

"This research project includes 60 participants between the ages of 25 and 90 with rotator cuff tears. In order to qualify, they must be able to give consent for participation, confirm their tear through an expert's diagnosis and abide by scheduled follow-up visits or procedures."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Subacromial Bursa Re-Implantation After Rotator Cuff Repair

James M. Gregory 2021. "Subacromial Bursa Re-Implantation After Rotator Cuff Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04634084.