RecruitingNot ApplicableNCT04728282

Comparison of Lateralized RTSA With and Without Subscapularis Repair

Randomized Clinical Trial Comparing Lateralized Reverse Total Shoulder Arthroplasty (RTSA) With and Without Subscapularis Repair

Sponsor

Panam Clinic

Enrollment

284 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

Arthritis Shoulder

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

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria11

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

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Interventions

PROCEDURERTSA with subscapularis repair

Lateralized reverse total shoulder arthroplasty with repair of subscapularis

PROCEDURERTSA without subscapularis repair

Lateralized reverse total shoulder arthroplasty without repair of subscapularis

Locations(1)

Pan Am Clinic

Winnipeg, Manitoba, Canada

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NCT04728282

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