Comparison of Lateralized RTSA With and Without Subscapularis Repair

Last updated: February 23, 2026
Sponsor: Panam Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Treatment

RTSA without subscapularis repair

RTSA with subscapularis repair

Clinical Study ID

NCT04728282
RSASUB-16-01-2021
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of glenohumeral arthritis, rotator cuff arthropathy, or massiveirreparable 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

Exclusion Criteria:

  • 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 toarrange 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 asone that is not of sufficient quality or does not allow adequate excursion to reachthe repair site

  • Any anatomical or patient characteristic that warrants a non-lateralized implant

Study Design

Total Participants: 284
Treatment Group(s): 2
Primary Treatment: RTSA without subscapularis repair
Phase:
Study Start date:
November 01, 2021
Estimated Completion Date:
March 01, 2030

Study Description

The main objective of this study is to compare patient-reported outcome measures (PROMs), and clinical and functional outcomes between RTSA with and without subscapularis repair. The specific aims for this study are:

Specific Aim 1:

To determine if there is a difference in PROM scores between RTSA with and without subscapularis repair during the 24-month postoperative period.

Specific Aim 2:

To determine if there is a difference between the two surgical approaches with respect to shoulder function, specifically range of motion and strength, during the 24-month postoperative period.

Specific Aim 3:

To determine if there is a difference in shoulder dislocation rates between RTSA with and without subscapularis repair during the 24-month postoperative period.

Specific Aim 4:

To determine if there is a difference in surgical complications, re-operation or revision rates between RTSA with and without subscapularis repair during the 24-month postoperative period.

Specific Aim 5:

To quantify the operative times for RTSA with and without subscapularis repair, and determine if there is a difference between the two approaches.

Connect with a study center

  • Pan Am Clinic

    Winnipeg, Manitoba R3M 3E4
    Canada

    Site Not Available

  • Pan Am Clinic

    Winnipeg 6183235, Manitoba 6065171 R3M 3E4
    Canada

    Active - Recruiting

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