Randomized Clinical Trial Comparing Lateralized Reverse Total Shoulder Arthroplasty (RTSA) With and Without Subscapularis Repair
Who is this study for? Patients with glenohumeral arthritis, rotator cuff arthropathy, or massive irreparable rotator cuff tear with surgeon-patient decision to undergo RTSA
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Canada
Pan Am Clinic
RECRUITING
Winnipeg
Contact Information
Primary
Sheila McRae, PhD
smcrae@panamclinic.com
204-925-7469
Backup
Derek McLennan, BSc
dmclennan@panamclinic.com
204-927-2828
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2030-03-01
Participants
Target number of participants: 284
Treatments
Experimental: RTSA with subscapularis repair
Active_comparator: RTSA without subscapularis repair
Related Therapeutic Areas
Sponsors
Leads: Panam Clinic
Collaborators: University of Manitoba