Actively Recruiting
Randomized Clinical Trial Comparing Lateralized Reverse Total Shoulder Arthroplasty With and Without Subscapularis Repair
Led by Panam Clinic · Updated on 2026-02-25
284
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
P
Panam Clinic
Lead Sponsor
U
University of Manitoba
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing patient outcomes in people undergoing reverse total shoulder arthroplasty (RTSA) with and without repair of the subscapularis muscle. This study focuses on a modern lateralized implant and aims to assess differences in patient-reported outcomes, shoulder function, dislocation rates, surgical complications, and operative times over a 24-month period after surgery. Participants will receive one of two surgical procedures: RTSA with subscapularis repair or RTSA without subscapularis repair. Both use the lateralized implant design. The study is randomized and double-blind, meaning neither patients nor clinicians know which procedure is performed. These two approaches will be compared directly during the postoperative follow-up. During the 24 months after surgery, participants will undergo multiple assessments including clinical exams, strength and range of motion measurements, and patient questionnaires such as the ASES, Constant, SANE, and EQ5D-3L scores. Researchers will monitor complications, dislocation rates, and the need for revision surgery. Operative time will also be recorded. Follow-up visits occur at baseline, 3, 6, 12, and 24 months post-operation to collect detailed outcome data.
CONDITIONS
Brief Title
Comparison of Lateralized RTSA With and Without Subscapularis Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of glenohumeral arthritis, rotator cuff arthropathy, or massive irreparable rotator cuff tear with decision to undergo RTSA
- First reverse total shoulder arthroplasty implantation
- No cancerous disease at the treatment site
- Low-grade fatty infiltration of the subscapularis muscle (less than Grade 3) based on pre-operative CT scan
You will not qualify if you...
- Previous shoulder arthroplasty surgery (hemiarthroplasty, total shoulder, or RTSA)
- Avascular necrosis
- Post-infectious arthritis
- Proximal humerus fracture
- Inflammatory arthritis
- Inability to communicate in English
- Unable to attend follow-up visits for 24 months post-operation
- During surgery: subscapularis fatty infiltration Grade 3 or higher
- Subscapularis tendon deemed irreparable
- Anatomical or patient factors requiring a non-lateralized implant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and hospital stay as per routine care
Participants undergo lateralized reverse total shoulder arthroplasty either with or without subscapularis repair followed by immediate post-operative care.
1 surgical visit (in-person)
Duration - 24 months post-operative
Participants are followed for 24 months after surgery to assess recovery, shoulder function, range of motion, strength, and patient-reported outcomes.
Visits at baseline pre-operative, 3, 6, 12, and 24 months post-operative
Trial Site Locations
Total: 1 location
1
Pan Am Clinic
Winnipeg, Manitoba, Canada, R3M 3E4
Actively Recruiting
Research Team
S
Sheila McRae, PhD
D
Derek McLennan, BSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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