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Subscapularis Repair in Shoulder Replacement for Shoulder Arthropathy

N/A
Waitlist Available
Led By Alexander W Aleem, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults undergoing primary reverse shoulder arthroplasty
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years
Awards & highlights

Study Summary

This trial is testing whether repairing the subscapularis tendon during shoulder replacement surgery has better outcomes than not repairing it. It is enrolling patients now.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include pain at the surgery site, infection risk from the procedure, and possible complications related to anesthesia or surgical intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having my first reverse shoulder replacement surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
American Shoulder and Elbow Surgeons Score
Secondary outcome measures
Simple Shoulder Test

Trial Design

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 Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,607 Total Patients Enrolled
Alexander W Aleem, MDPrincipal InvestigatorWashington University School of Medicine

Media Library

Repair Clinical Trial Eligibility Overview. Trial Name: NCT03727490 — N/A
Shoulder Arthropathy Research Study Groups: Control, Study
Shoulder Arthropathy Clinical Trial 2023: Repair Highlights & Side Effects. Trial Name: NCT03727490 — N/A
Repair 2023 Treatment Timeline for Medical Study. Trial Name: NCT03727490 — N/A

Frequently Asked Questions

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

Are enrollment applications to this research being accepted currently?

"Affirmative. The clinicaltrials.gov website reveals that this medical study, initially posted on the 1st of January 2017, is actively recruiting participants. There are a total of 100 positions available at one centre."

Answered by AI

How many participants are enrolled in this research project?

"Correct. According to clinicaltrials.gov, the recruitment process for this study is now underway; it was originally posted on January 1st 2017 and last modified on July 7th 2022. The total number of participants needed is 100 people from a single trial centre."

Answered by AI
~8 spots leftby Jan 2025