Comparison of Lateralized RTSA With and Without Subscapularis Repair

Panam Clinic

Status and phase

Enrolling

Early Phase 1

Conditions

Arthritis Shoulder

Treatments

Procedure: RTSA without subscapularis repair

Procedure: RTSA with subscapularis repair

Study type

Interventional

Funder types

Other

Identifiers

NCT04728282

RSASUB-16-01-2021

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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