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| Name | Class |
|---|---|
| NAMSA | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMR Stemless Reverse | Experimental |
| |
| SMR Reverse Shoulder System | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Arm: SMR Stemless Reverse | Device | The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function. |
| 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. |
Radiographic: Implant Loosening
| 24 Months |
| 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 |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabiana Pavan | Contact | +39 348 5816391 | Fabiana.Pavan@limacorporate.com | |
| Tory Sears | Contact | 574-377-1563 | tsears@namsa.com |
| Name | Affiliation | Role |
|---|---|---|
| Grant Garrigues, M.D. | Rush Orthopedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Kerlan-Jobe Institute | Withdrawn | Los Angeles | California | 90045 | United States | |
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The 200 randomized subjects will be randomized 1:1 to SMR Stemless Reverse and SMR Reverse Shoulder System.
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| Control Arm: SMR Reverse Shoulder System | Device | Conventional stemmed shoulder prostheses are commonly used in the clinical practice. |
|
| 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:
| 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) |
| Western Orthopaedics |
| Active, not recruiting |
| Denver |
| Colorado |
| 80218 |
| United States |
| Levy Shoulder Center | Recruiting | Boca Raton | Florida | 33428 | United States |
|
| AdventHealth | Recruiting | Orlando | Florida | 32803 | United States |
|
| Rush Orthopaedics | Recruiting | Chicago | Illinois | 60612 | United States |
|
| Upstate Orthopedics | Recruiting | East Syracuse | New York | 13057 | United States |
|
| Duke University | Active, not recruiting | Durham | North Carolina | 27708 | United States |
| University of Pennsylvania | Withdrawn | Philadelphia | Pennsylvania | 19104 | United States |
| Rothman Orthopaedic | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
|
| Guthrie | Recruiting | Sayre | Pennsylvania | 18840 | United States |
|
| University of Texas- Health Science Center | Recruiting | San Antonio | Texas | 78229 | United States |
|
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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