102 Participants Needed

Subscapularis Repair in Shoulder Replacement for Shoulder Arthropathy

JS
Overseen ByJulianne Sefko, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The overall goal of the study is to determine if repairing the subscapularis tendon during primary reverse shoulder arthroplasty effects short-term patient outcomes. The study is a patient blinded randomized controlled trial that is currently enrolling.

Research Team

AW

Alexander W Aleem, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for adults who are about to have their first reverse shoulder arthroplasty, a type of shoulder replacement surgery. It's not open to those without an intact subscapularis tendon, those with inflammatory arthritis, or anyone needing revision surgery.

Inclusion Criteria

I am having my first reverse shoulder replacement surgery.

Exclusion Criteria

I have inflammatory arthritis.
I am an adult scheduled for a corrective surgery.
My subscapularis (shoulder muscle) is not intact.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo reverse shoulder arthroplasty with or without subscapularis tendon repair

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

104 weeks
Regular follow-up visits over two years

Treatment Details

Interventions

  • Repair
  • Standard Treatment
Trial Overview The study is testing whether repairing the subscapularis tendon during the initial reverse shoulder arthroplasty improves short-term patient outcomes compared to standard treatment without repair. Participants won't know which group they're in.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: StudyExperimental Treatment1 Intervention
This group will have the subscapularis tendon repaired through a bone to bone repair that will add approximately 5 minutes to the surgical procedure.
Group II: ControlActive Control1 Intervention
This group will have the subscapularis left un-repaired, which is the standard of care for our institution for reverse shoulder arthroplasty.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+
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