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Subscapularis Repair During Reverse Total Shoulder Arthroplasty for Shoulder Osteoarthritis

N/A

Waitlist Available

Led By Guido Marra, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Operation will be performed by a participating surgeon using Zimmer Biomet Comprehensive Reverse Shoulder System implant

Primary RSA procedure with repairable (intact) SSc

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months post-surgery

Awards & highlights

Study Summary

This trial will compare outcomes of patients who have a subscapularis repair during reverse shoulder arthroplasty to those who don't, in order to answer the question of whether or not the repair contributes to better post-operative outcomes.

Who is the study for?

This trial is for adults with shoulder joint issues like arthritis, who need a reverse total shoulder arthroplasty (RSA) and can have their subscapularis muscle repaired. They must be fluent in English and will receive a specific implant from Zimmer Biomet during surgery by participating surgeons.Check my eligibility

What is being tested?

The study compares outcomes of patients getting RSA with or without the repair of the subscapularis muscle. It's designed to see if not repairing this muscle leads to better recovery after shoulder replacement surgery.See study design

What are the potential side effects?

While specific side effects are not listed, typical risks may include pain, infection, stiffness, or problems related to anesthesia from the surgical procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My surgery will use a Zimmer Biomet shoulder implant.

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I am having my first RSA surgery and my SSc is repairable.

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I have been diagnosed with joint issues due to a weak rotator cuff.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post-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

The American Shoulder and Elbow Surgeons (ASES) Shoulder Score

Secondary outcome measures

Internal Rotator (IR) Strength

Pain

Shoulder Range of Motion

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Subscapularis repairExperimental Treatment1 Intervention

Patients will undergo standard of care reverse total shoulder arthroplasty with subscapularis repair

Group II: No repairActive Control1 Intervention

Patients will undergo standard of care reverse total shoulder arthroplasty. The subscapularis will not be repaired.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,231 Total Patients Enrolled

Guido Marra, MDPrincipal InvestigatorNorthwestern University Feinberg School of Medicine

Media Library

Subscapularis repair Clinical Trial Eligibility Overview. Trial Name: NCT05341518 — N/A

Shoulder Arthropathy Research Study Groups: No repair, Subscapularis repair

Shoulder Arthropathy Clinical Trial 2023: Subscapularis repair Highlights & Side Effects. Trial Name: NCT05341518 — N/A

Subscapularis repair 2023 Treatment Timeline for Medical Study. Trial Name: NCT05341518 — N/A

Frequently Asked Questions

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

Are there any opportunities for recruitment into this research project at the moment?

"Clinicaltrials.gov attests that this trial is not currently enrolling volunteers; the initial posting was on September 1, 2022 and the most recent edit occurred April 18th of that same year. Although no longer recruiting for participants, there are 709 other trials still accepting applications."

Answered by AI

Does the enrollment criteria for this experiment accept individuals younger than sixty years old?

"This medical trial has a participation age range of 18 to 88 years old. Under-18s have 37 clinical trials available and those over 65 can partake in 666 different studies."

Answered by AI

Am I eligible to volunteer for this research?

"This clinical trial is designed to include 150 individuals suffering from arthrosis, aged between 18 and 88. Candidates must meet the following prerequisites: a primary RSA procedure with an unharmed SSc, operated on by one of the participating surgeons using Zimmer Biomet Comprehensive Reverse Shoulder System implantation; imaging evidence suggesting rotator cuff deficiency combined with arthropathy; deltopectoral surgical approach; competency in English language comprehension (both verbal and written)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Subscapularis Repair During Reverse Total Shoulder Arthroplasty

Guido Marra 2023. "Subscapularis Repair During Reverse Total Shoulder Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05341518.