Comparison of Lateralized RTSA With and Without Subscapularis Repair
ConditionArthritis Shoulder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPanam Clinic
About 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Previous shoulder arthroplasty (hemi-, total shoulder, or RTSA)
Avascular necrosis
Post-infectious arthritis
Proximal humerus fracture
Trial design
Treatments tested in this trial
- RTSA with subscapularis repair
- RTSA without subscapularis repair
Treatment groups
284 Participants
are divided into 2 treatment groupsSponsors and collaborators
Panam Clinic
Lead sponsor
University of Manitoba
Collaborator
Source ClinicalTrials.gov