Subscapularis Repair in Shoulder Replacement for Shoulder Arthropathy

Overseen By Julianne Sefko, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Inflammatory arthritis, Revision surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

102 Participants Needed

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

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

Group I: Study Experimental Treatment 1 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: Control Active Control 1 Intervention

This group will have the subscapularis left un-repaired, which is the standard of care for our institution for reverse shoulder arthroplasty.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+