Recruiting

Lateralized RTSA vs. Subscapularis Repair

Sponsor:

Panam Clinic

Code:

NCT04728282

Conditions

Arthritis Shoulder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RTSA with subscapularis repair

RTSA without subscapularis repair

Study Details

Brief 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.

Conditions

Arthritis Shoulder

Study ID

NCT04728282

Start date

Nov 1, 2021

Status verified date

Feb, 2026

Completion date

Mar 1, 2030

Anticipated

Primary completion date

Mar 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 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 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

Study Design

Enrollment

284 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RTSA with subscapularis repair

active comparator: RTSA without subscapularis repair

Interventions

RTSA with subscapularis repair

Lateralized reverse total shoulder arthroplasty with repair of subscapularis

RTSA without subscapularis repair

Lateralized reverse total shoulder arthroplasty without repair of subscapularis

Primary outcome measure

  • ASES Score [ Time Frame: 24 months post-operative ]

Central Contacts and Locations

Central contacts

Sheila McRae, PhD

204-925-7469smcrae@panamclinic.com

Derek McLennan, BSc

204-927-2828dmclennan@panamclinic.com

Locations

Pan Am Clinic

Recruiting

Winnipeg, Manitoba, Canada, R3M 3E4

Contacts

Sheila McRae, PhD

204-925-7469smcrae@panamclinic.com

More Information

Sponsor

Panam Clinic

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

  • reverse total shoulder arthroplasty
  • subscapularis
  • repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Panam Clinic on 2026-02-25.