Actively Recruiting
Comparison of Lateralized RTSA With and Without Subscapularis Repair
Led by Panam Clinic · Updated on 2026-02-25
284
Participants Needed
1
Research Sites
434 weeks
Total Duration
On this page
Sponsors
P
Panam Clinic
Lead Sponsor
U
University of Manitoba
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 surgeon-patient decision to undergo RTSA
- First RTSA implantation
- Absence of neoplastic diseases at the treated site
- Fatty infiltration of the subscapularis is low-grade (i.e. Goutallier < Grade 3) based on pre-operative CT performed as standard of care in the patient group
You will not qualify if you...
- Previous shoulder arthroplasty (hemi-, total shoulder, or RTSA)
- Avascular necrosis
- Post-infectious arthritis
- Proximal humerus fracture
- Inflammatory arthritis
- Inability to communicate in English
- Unable to return for study visits to 24-months post-operative (e.g. unable to arrange transportation to study appointments, plans to relocate, etc.)
Intra-operative Exclusions:
- Subscapularis with fatty infiltration (Goutallier ≥ 3)
- Subscapularis that is deemed to be irreparable. An irreparable tendon is defined as one that is not of sufficient quality or does not allow adequate excursion to reach the repair site
- Any anatomical or patient characteristic that warrants a non-lateralized implant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pan Am Clinic
Winnipeg, Manitoba, Canada, R3M 3E4
Actively Recruiting
Research Team
S
Sheila McRae, PhD
CONTACT
D
Derek McLennan, BSc
CONTACT
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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