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Recruiting NCT04728282

Comparison of Lateralized RTSA With and Without Subscapularis Repair

No phase Interventional Arthritis Shoulder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RTSA with subscapularis repair, RTSA without subscapularis repair.
Who it may be relevant to
Registry conditions: Arthritis Shoulder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed 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.

Interventions

  • Procedure RTSA with subscapularis repair
    Lateralized reverse total shoulder arthroplasty with repair of subscapularis
  • Procedure RTSA without subscapularis repair
    Lateralized reverse total shoulder arthroplasty without repair of subscapularis

Primary outcome measures

  • ASES Score [Time frame: 24 months post-operative]
Secondary outcome measures (12)
  • Constant Score [Time frame: baseline pre-operative]
  • Constant Score [Time frame: 3 months post-operative]
  • Constant Score [Time frame: 6 months post-operative]
  • Constant Score [Time frame: 12 months post-operative]
  • Constant Score [Time frame: 24 months post-operative]
  • SANE Score [Time frame: baseline pre-operative]
  • SANE Score [Time frame: 3 months post-operative]
  • SANE Score [Time frame: 6 months post-operative]
  • SANE Score [Time frame: 12 months post-operative]
  • SANE Score [Time frame: 24 months post-operative]
  • EQ5D-3L [Time frame: baseline, pre-operative]
  • EQ5D-3L [Time frame: 3 months, post-operative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Pan Am Clinic — Winnipeg

Identifiers

NCT: NCT04728282 · RSASUB-16-01-2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗