Comparison of Lateralized RTSA With and Without Subscapularis Repair

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2027-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arthritis Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a double-blinded randomized clinical trial comparing two groups, RTSA with and RTSA without subscapularis repair. Eighty-four participants will be randomized at a 1:1 ratio in blocks of 12. All participants will be recruited from the patient populations of six fellowship trained upper extremity orthopaedic surgeons at initial consult. Patients will be randomized intraoperatively using a telephone/web-based system.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Patients will be blinded to their group allocation. This is possible because the incision and rehabilitation processes are consistent between groups. It is not possible for the treating surgeon to be blinded to group allocation, therefore a research team member (athletic or physical therapist) will remain blinded to group allocation and conduct all study related assessments as well as administer the patient-reported questionnaires. This will be maintained by the participant not removing their shirt during the study assessment. Patients will not be informed of which procedure they will undergo until the study is complete.

Study Groups

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RTSA with subscapularis repair

Group Type EXPERIMENTAL

RTSA with subscapularis repair

Intervention Type PROCEDURE

Lateralized reverse total shoulder arthroplasty with repair of subscapularis

RTSA without subscapularis repair

Group Type ACTIVE_COMPARATOR

RTSA without subscapularis repair

Intervention Type PROCEDURE

Lateralized reverse total shoulder arthroplasty without repair of subscapularis

Interventions

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RTSA with subscapularis repair

Lateralized reverse total shoulder arthroplasty with repair of subscapularis

Intervention Type PROCEDURE

RTSA without subscapularis repair

Lateralized reverse total shoulder arthroplasty without repair of subscapularis

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No