SMR Stemless Reverse vs SMR Reverse Shoulder System

Condition(s) studied

Investigational drug(s) / intervention(s)

Investigational Arm: SMR Stemless Reverse: The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function.

Control Arm: SMR Reverse Shoulder System: Conventional stemmed shoulder prostheses are commonly used in the clinical practice.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Primary Efficacy Endpoint-Constant Murley Score — 24 Months
  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.
• Primary Safety Endpoint-Absence of revisions, reoperations, and implant loosening. — 24 Months
  * 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.

Trial sites (13)

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