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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function.
Conventional stemmed shoulder prostheses are commonly used in the clinical practice.
Cedars-Sinai Kerlan-Jobe Institute
Los Angeles, California, United States
WITHDRAWNWestern Orthopaedics
Denver, Colorado, United States
ACTIVE_NOT_RECRUITINGLevy Shoulder Center
Boca Raton, Florida, United States
RECRUITINGAdventHealth
Orlando, Florida, United States
RECRUITINGRush Orthopaedics
Chicago, Illinois, United States
RECRUITINGUpstate Orthopedics
East Syracuse, New York, United States
RECRUITINGDuke University
Durham, North Carolina, United States
ACTIVE_NOT_RECRUITINGUniversity of Pennsylvania
Philadelphia, Pennsylvania, United States
WITHDRAWNRothman Orthopaedic
Philadelphia, Pennsylvania, United States
RECRUITINGGuthrie
Sayre, Pennsylvania, United States
RECRUITING...and 1 more locations
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.
Time frame: 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.
Time frame: 24 Months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: From enrollment to the final study visit (24 months)
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