Comparison of Lateralized RTSA With and Without Subscapularis Repair
- Conditions
- Arthritis Shoulder
- Interventions
- Procedure: RTSA with subscapularis repairProcedure: RTSA without subscapularis repair
- Registration Number
- NCT04728282
- Lead Sponsor
- Panam Clinic
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 84
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RTSA with subscapularis repair RTSA with subscapularis repair - RTSA without subscapularis repair RTSA without subscapularis repair -
- Primary Outcome Measures
Name Time Method ASES Score 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 Outcome Measures
Name Time Method EQ5D-3L 24 months, post-operative The EQ-5D is valid, reliable, responsive PROM used to document overall wellness based on 5 dimensions: mobility, self-care, usual activities, pain, anxiety/depression (Herdman et al., 2011). A single value is calculated (the value index), which indicates how good or bad a patient's health state is relative to a specified population. There are two components, VAS for general health, with 0 minimum and 100 maximum, with higher scores being more positive. The second component is a 25 point scale with minimum 5 and maximum 25 wit h lower scores more positive.
Range of Motion 24 months, post-operative For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees.
SANE Score 24 months post-operative The Single Assessment Numeric Evaluation (SANE) score is a single question that asks patients to rate their affected shoulder as a percentage of normal to provide a simple and efficient measure of patient outcome (Gowd et al., 2019). Patients will be asked the following question: "How would you rate your affected shoulder today as a percentage of normal (0% to 100% scale with 100% being normal)?"
Constant Score 24 months post-operative The Constant Score is validated and reliable PROM/clinical tool used to evaluate overall shoulder function based on pain, activities of daily living, and the clinical evaluation of ROM and strength (Constant \& Murley, 1987). This score is widely reported in European-based literature. Minimum value is 0 and maximum value is 100, with higher scores being a better outcome.
Isometric Strength 24 months, post-operative Measured using a hand-held dynamometer, in flexion, abduction, and external rotation
ASES Score 12 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.
Trial Locations
- Locations (1)
Pan Am Clinic
🇨🇦Winnipeg, Manitoba, Canada