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Rotator Cuff Repair Techniques for Shoulder Injuries

N/A
Recruiting
Led By Mohit Gilotra, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients undergoing reverse shoulder arthroplasty for any indication including revision surgery
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-op and post-op months 3,6,12,24
Awards & highlights

Study Summary

This trial is researching whether rotator cuff repair can reduce risks and improve outcomes after shoulder replacement. 148 patients will be enrolled and followed for 5yrs. Participation is voluntary, no costs or payments associated.

Who is the study for?
This trial is for individuals aged 18 to 95 who are undergoing reverse shoulder arthroplasty, which could include revision surgery. Candidates must have an intact subscapularis tendon with minimal fatty infiltration and no history of proximal humerus fracture or bone loss.Check my eligibility
What is being tested?
The study compares outcomes of reverse shoulder arthroplasty with two different approaches to the subscapularis tendon: one group will have the tendon released (Subscap Tenotomy), while another will have it repaired (Subscap Repair). The aim is to see if repair affects dislocation risk, range of motion, or internal rotation strength.See study design
What are the potential side effects?
Potential side effects may include limited range of motion, changes in internal rotation strength, or complications like dislocation. There's also a small risk that personal information could be exposed due to data collection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having or have had a reverse shoulder replacement surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-op and post-op months 3,6,12,24
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-op and post-op months 3,6,12,24 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 BOSS Scores
Change in Internal Rotation
Secondary outcome measures
Change in ASES score
Other outcome measures
Ultrasound Evaluation

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subscap TenotomyExperimental Treatment1 Intervention
Group II: Subscap RepairExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,538 Total Patients Enrolled
1 Trials studying Rotator Cuff Tears
84 Patients Enrolled for Rotator Cuff Tears
Mohit Gilotra, MDPrincipal InvestigatorUniversity of Maryland, Baltimore

Media Library

Subscap Tenotomy Clinical Trial Eligibility Overview. Trial Name: NCT05344898 — N/A
Rotator Cuff Tears Research Study Groups: Subscap Tenotomy, Subscap Repair
Rotator Cuff Tears Clinical Trial 2023: Subscap Tenotomy Highlights & Side Effects. Trial Name: NCT05344898 — N/A
Subscap Tenotomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05344898 — N/A
Rotator Cuff Tears Patient Testimony for trial: Trial Name: NCT05344898 — N/A

Frequently Asked Questions

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

Does the age limit for joining this experiment extend beyond 50 years old?

"This clinical trial has a permissible age range of 18 to 95, as per the eligibility standards."

Answered by AI

Is this investigation actively seeking participants at the moment?

"Yes, per the clinicaltrials.gov database, which was last updated on March 27th 2023, this trial is actively seeking new participants. A total of 118 individuals must be enrolled across 1 medical centre."

Answered by AI

What are the qualifications necessary to participate in this clinical trial?

"This clinical experiment is searching for 118 participants, ranging from 18 to 95 years of age, with a rotator cuff injury. Furthermore, these individuals must have been deemed eligible by their physicians for reverse shoulder arthroplasty - including those undergoing revision surgery."

Answered by AI

What is the participant limit for this clinical research?

"Indeed, the clinical trial is still in search of participants. According to records on clinicaltrials.gov, it was initially advertised on November 15th 2022 and its most recent update was posted March 27th 2023. The study needs 118 patients from one site for participation."

Answered by AI

Who else is applying?

What state do they live in?
District of Columbia
Maryland
What site did they apply to?
University of Maryland School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I've had a torn rotator cuff for 8 years and no one will fix it as my insurance won't cover the cost, please let me try this new procedure.
PatientReceived 2+ prior treatments
I've had this for more than 8 years now and I have tried to get the surgery but my insurance doesn't cover the procedure, I will travel wherever you want, just give me the Chance to repair my shoulder.
PatientReceived 1 prior treatment
I've been living with a severely torn rotator cuff for 10 + years because I don't have the money to get it fixed , it's very painful and I have severe limitation on any movement, and it's my primary arm, please let me try this, I'm so distressed by this injury while I was curling weight many years ago......,.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Subscap Reverse Shoulder Arthroplasty
Mohit N. Gilotra 2022. "Subscap Reverse Shoulder Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05344898.
~79 spots leftby May 2027
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