SMR Stemless Reverse vs SMR Reverse Shoulder System

Study Overview
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Brief Summary
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The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function. This is a prospective, multi-center, randomized, controlled trial to demonstrate non-inferiority of the SMR Stemless Reverse to the SMR Reverse Shoulder System. Patients with joint dysfunction who continue to experience significant symptoms despite an appropriate course of non-operative management are eligible. Patients will be considered enrolled into the study when an ICF has been signed, all inclusion criteria are met and no exclusion criteria are present including intraoperative exclusion criteria, and the patient is randomized into either the SMR Stemless Reverse (investigational) group, the SMR Reverse Shoulder System (control) group or is part of the roll-in population. Enrollment is expected to take approximately 24 months.

Official Title
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A Randomized, Multi-Center, Prospective, Safety and Efficacy Study Comparing the Outcome of Total Reverse Shoulder Arthroplasty (RSA) With SMR Stemless Reverse vs SMR Reverse Shoulder System

Conditions
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Arthroplasty, Replacement

Intervention / Treatment
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* Device: Investigational Arm: SMR Stemless Reverse
* Device: Control Arm: SMR Reverse Shoulder System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 22 years of age Skeletally mature as evident by scapula and proximal humerus closure Candidate for primary total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder), when clinical indications based on physical exam and medical history including one or more of the following: Arthritis with rotator cuff tear not reparable Irreparable rotator cuff tear Rotator cuff tear arthropathy Severe osteoarthritis and rotator cuff deficiency or stiff shoulder Significant glenoid or socket side bone deformed or loss Reoccurrence of instability or a chronic shoulder dislocation Any other medical reason that the investigator determine that subject is a good candidate for a reverse total shoulder arthroplasty Exclusion Criteria: BMI > 40 kg/m2 Previous contralateral shoulder surgery within 3 months of enrollment or that requires active treatment (i.e. surgery or brace) Had surgery in the targeted shoulder within last 12 months of enrollment, except diagnostic arthroscopy without procedures Had surgery in lower limbs (such as hip or knee) within last 6 months of enrollment Corticosteroid injections in the ipsilateral shoulder within 3 months of enrollment Complete deltoid muscle insufficiency Glenoid retroversion great than 25 degrees based off a 2D axial CT scan History of/or signs and/or symptoms of local or systemic infection including but not limited to septicemia; osteomyelitis Neurologically confirmed nerve lesion compromising shoulder joint function Poor meta-epiphyseal bone stock compromising stability of the implant including but not limited to humeral head fracture, iatrogenic glenoid fracture, severe osteoporosis Metabolic disorders which may impair fixation and stability of the implant including but not limited to uncontrolled diabetes mellitus with an HbA1C > 7.5% Extended bone loss after previous surgery defined as: complete bone loss of greater and lesser tuberosity Meta-epiphyseal bony defect (including large cyst)

Ages Eligible for Study
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Minimum Age: 22 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: The 200 randomized subjects will be randomized 1:1 to SMR Stemless Reverse and SMR Reverse Shoulder System.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMR Stemless Reverse<br> | Device: Investigational Arm: SMR Stemless Reverse<br>* The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function.<br>|
| Active Comparator: SMR Reverse Shoulder System<br> | Device: Control Arm: SMR Reverse Shoulder System<br>* Conventional stemmed shoulder prostheses are commonly used in the clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Efficacy Endpoint-Constant Murley Score | The primary efficacy endpoint is to assess successful clinical outcomes by Constant-Murley Score (CMS) adjusted for gender and age at month 24 defined as an increase in CMS of at least 15 points over baseline CMS. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The higher the score, the higher the quality of the function. | 24 Months | 
| Primary Safety Endpoint-Absence of revisions, reoperations, and implant loosening. | Revisions - A revision is a procedure that adjusts, modifies, or removes part of the original implant configuration, with or without replacement of a component. This may include removing a component of a joint implant. Reoperations - A reoperation is any surgical procedure involving the repaired shoulder that does not include removal, modification, or addition of any components to the investigational device (e.g., drainage of a hematoma at the surgical site). Radiographic: Implant Loosening A humeral component is considered to be at risk for loosening when a radiolucent line >2 mm is present in four (4) or more of the eight (8) zones or if there is conclusive evidence of migration or tilt of the component. A glenoid component is considered to be at risk for loosening in case of conclusive evidence of a migration or tilt of the component or in presence of a circumferential radiolucent line of at least 2 mm around the glenoid component. | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Efficacy Measure-Constant-Murley Score | The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The higher the score, the higher the quality of the function. | 3, 6, and 12 month visits | 
| Secondary Efficacy Measure-American Shoulder and Elbow Surgeons Shoulder Score (ASES) | The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition. | 3, 6, 12 and 24 month visits | 
| Secondary Efficacy Measure-Simple Shoulder Test (SST) | Simple Shoulder Test (SST) is a series of 12 yes or no questions the patient answers about the function of the involved shoulder. The answers to these questions provides a standardized way of recording the function of a shoulder before and after treatment. The difference between the shoulder function before treatment and after the recovery period is the effectiveness of the treatment. | 3, 6, 12 and 24 month visits | 
| Secondary Efficacy Measure-EQ-5D-5L | The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable condition of health. | 3, 6, 12 and 24 month visits | 
| Secondary Efficacy Measure-Range of Motion (ROM) | will be summarized using the mean, standard deviation, sample size, median and minimum and maximum scores and will be presented separately for the SMR Stemless Reverse and SMR Reverse Shoulder System implant groups. | 3, 6, 12 and 24 month visits | 
| Secondary Efficacy Measure-Single Assessment Numeric Evaluation (SANE) | The Single Assessment Numeric Evaluation (SANE) is a simple, one-question patient-reported outcome measures. Patient reported outcome measures (PROMs) quantify symptoms and limitations in people with musculoskeletal illness. The Single Assessment Numeric Evaluation (SANE) is a patient rating from 0-100. Patients rate their current illness score in relation to their pre-injury baseline. | 3, 6, 12 and 24 month visits | 
| Secondary Safety Measure-Serious Procedure or Device Related Adverse Events | Serious Procedure or Device Related Adverse Events, device deficiencies, malfunctions and use errors at all follow-up time points | From enrollment to the final study visit (24 months) | 
| Secondary Safety Measure-Absence of Subsequent Secondary Surgical Interventions | Absence of: Removals - A removal is a procedure where all of the original system configuration is removed with or without replacement due to, for example, mechanical failure of the device, pain, or infection. Supplemental Fixations - A supplemental fixation is a procedure in which additional instrumentation not under study in the protocol is implanted (e.g., supplemental placement of a rod/screw) | From enrollment to the final study visit (24 months) | 
| Secondary Safety Measure-Radiographic: Standard CT and x-ray scans | Presence/absence of and fracture, radiolucent , migration, mal-alignment or loss of reduction or fixation. | From enrollment to the final study visit (24 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder Joint, Shoulder Replacement, Arthritis with rotator cuff tear, Post traumatic fracture sequele, Severe osteoarthritis and rotator cuff deficiency, Significant glenoid or socket side bone deformed or loss, Reoccurrence of instability or chronic shoulder dislocation, Severe osteoarthritis and stiff shoulder