Randomized Clinical Trial Comparing Lateralized Reverse Total Shoulder Arthroplasty (RTSA) With and Without Subscapularis Repair
Overview
- Phase
- Not Applicable
- Intervention
- RTSA with subscapularis repair
- Conditions
- Arthritis Shoulder
- Sponsor
- Panam Clinic
- Enrollment
- 284
- Locations
- 1
- Primary Endpoint
- ASES Score
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
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.
Investigators
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
Arms & Interventions
RTSA with subscapularis repair
Intervention: RTSA with subscapularis repair
RTSA without subscapularis repair
Intervention: RTSA without subscapularis repair
Outcomes
Primary Outcomes
ASES Score
Time Frame: 24 months post-operative
The ASES is a patient-reported upper extremity-specific functional assessment tool and is scored out of a maximum 100 points, where 100 represents maximum function and no pain (Richards et al., 1994). It has a pain component measured on a visual analog scale as well as ten Likert-scale questions on function (e.g., put on a coat, sleep on affected side). The ASES is reliable and is validated for this population and is one of the most commonly used shoulder outcomes in North America.
Secondary Outcomes
- EQ5D-3L(24 months, post-operative)
- Range of Motion(24 months, post-operative)
- SANE Score(24 months post-operative)
- Constant Score(24 months post-operative)
- Isometric Strength(24 months, post-operative)
- ASES Score(12 months, post-operative)
- Constant Score(baseline pre-operative)
- Constant Score(3 months post-operative)
- Constant Score(6 months post-operative)
- Constant Score(12 months post-operative)
- SANE Score(baseline pre-operative)
- SANE Score(3 months post-operative)
- SANE Score(6 months post-operative)
- SANE Score(12 months post-operative)
- EQ5D-3L(baseline, pre-operative)
- EQ5D-3L(3 months, post-operative)
- EQ5D-3L(6 months, post-operative)
- EQ5D-3L(12 months, post-operative)
- Range of Motion(baseline, pre-surgery)
- Range of Motion(3 months, post-operative)
- Range of Motion(6 months, post-operative)
- Range of Motion(12 months, post-operative)
- Isometric Strength(baseline, pre-surgery)
- Isometric Strength(3 months, post-operative)
- Isometric Strength(6 months, post-operative)
- Isometric Strength(12 months, post-operative)
- ASES Score(baseline, pre-operative)
- ASES Score(3 months, post-operative)
- ASES Score(6 months, post-operative)