Subscapularis Repair in Shoulder Replacement for Shoulder Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this double-blind randomized controlled trial is to compare patient-reported, clinical, and functional outcomes in patients undergoing RTSA with and without subscapularis repair after placement of a modern "lateralized" implant over the course of 24-months postoperative.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is subscapularis repair in reverse total shoulder arthroplasty generally safe?
Research suggests that subscapularis repair in reverse total shoulder arthroplasty (rTSA) is generally safe, with studies focusing on outcomes like joint stability and complication rates. While the role of subscapularis repair is debated, no significant safety concerns have been highlighted in the available studies.12345
How does the treatment of reverse total shoulder arthroplasty with or without subscapularis repair differ from other treatments for shoulder arthritis?
This treatment is unique because it involves a surgical procedure called reverse total shoulder arthroplasty (RTSA), where the shoulder joint is replaced and the role of repairing the subscapularis tendon (a muscle in the shoulder) is debated. The decision to repair the subscapularis tendon can affect shoulder stability and range of motion, but there is no clear consensus on whether it improves outcomes compared to not repairing it.12356
What data supports the effectiveness of the treatment RTSA with and without subscapularis repair for shoulder arthritis?
Research suggests that repairing the subscapularis (a shoulder muscle) during reverse total shoulder arthroplasty (RTSA) may influence outcomes like shoulder movement and stability, but its necessity is debated. Some studies indicate that subscapularis repair could reduce the risk of dislocation and improve clinical outcomes, though there is no clear consensus on its overall impact.12345
Who Is on the Research Team?
Jarret Woodmass
Principal Investigator
Pan Am Clinic
Are You a Good Fit for This Trial?
This trial is for individuals with shoulder arthritis or similar conditions who need their first RTSA implant and have a low-grade fatty infiltration in the subscapularis muscle. It's not for those who've had previous shoulder replacements, suffer from inflammatory arthritis, can't communicate in English, or won't be able to attend follow-up visits for 2 years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo RTSA with or without subscapularis repair
Postoperative Follow-up
Participants are monitored for clinical and functional outcomes, including PROMs, shoulder function, and surgical complications
Long-term Follow-up
Participants continue to be monitored for long-term outcomes and any late complications
What Are the Treatments Tested in This Trial?
Interventions
- RTSA without subscapularis repair
- RTSA with subscapularis repair
RTSA without subscapularis repair is already approved in European Union, United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Panam Clinic
Lead Sponsor
University of Manitoba
Collaborator