Comparison of Lateralized RTSA With and Without Subscapularis Repair

Study Overview
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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.

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.

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

Conditions
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Arthritis Shoulder

Intervention / Treatment
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* Procedure: RTSA with subscapularis repair
* Procedure: RTSA without subscapularis repair


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RTSA with subscapularis repair<br> | Procedure: RTSA with subscapularis repair<br>* Lateralized reverse total shoulder arthroplasty with repair of subscapularis<br>|
| Active Comparator: RTSA without subscapularis repair<br> | Procedure: RTSA without subscapularis repair<br>* Lateralized reverse total shoulder arthroplasty without repair of subscapularis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASES Score | 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. | 24 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Score | 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. | baseline pre-operative | 
| Constant Score | 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. | 3 months post-operative | 
| Constant Score | 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. | 6 months post-operative | 
| Constant Score | 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. | 12 months post-operative | 
| Constant Score | 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. | 24 months post-operative | 
| SANE Score | 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)? | baseline pre-operative | 
| SANE Score | 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)? | 3 months post-operative | 
| SANE Score | 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)? | 6 months post-operative | 
| SANE Score | 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)? | 12 months post-operative | 
| SANE Score | 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)? | 24 months post-operative | 
| EQ5D-3L | 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. | baseline, pre-operative | 
| EQ5D-3L | 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. | 3 months, post-operative | 
| EQ5D-3L | 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. | 6 months, post-operative | 
| EQ5D-3L | 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. | 12 months, post-operative | 
| EQ5D-3L | 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. | 24 months, post-operative | 
| Range of Motion | For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees. | baseline, pre-surgery | 
| Range of Motion | For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees. | 3 months, post-operative | 
| Range of Motion | For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees. | 6 months, post-operative | 
| Range of Motion | For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees. | 12 months, post-operative | 
| Range of Motion | For both shoulders, forward flexion and external rotation at 0 and 90 degrees abduction will be measured with a goniometer and reported in degrees. | 24 months, post-operative | 
| Isometric Strength | Measured using a hand-held dynamometer, in flexion, abduction, and external rotation | baseline, pre-surgery | 
| Isometric Strength | Measured using a hand-held dynamometer, in flexion, abduction, and external rotation | 3 months, post-operative | 
| Isometric Strength | Measured using a hand-held dynamometer, in flexion, abduction, and external rotation | 6 months, post-operative | 
| Isometric Strength | Measured using a hand-held dynamometer, in flexion, abduction, and external rotation | 12 months, post-operative | 
| Isometric Strength | Measured using a hand-held dynamometer, in flexion, abduction, and external rotation | 24 months, post-operative | 
| ASES Score | 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. | baseline, pre-operative | 
| ASES Score | 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. | 3 months, post-operative | 
| ASES Score | 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. | 6 months, post-operative | 
| ASES Score | 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. | 12 months, post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reverse total shoulder arthroplasty, subscapularis, repair