AEQUALIS™ FLEX REVIVE™ Study (REVIVE)

Stryker Trauma and Extremities

Status: Invitation-only

Conditions: Traumatic Arthritis; Fractures Humerus; Osteoarthritis Shoulder; Correction of Functional Deformity; Revision of Other Devices if Sufficient Bone Stock Remains; Avascular Necrosis; Rotator Cuff Tears; Rheumatoid Arthritis

Treatments: Device: Aequalis Flex Revive Shoulder System

Study type: Observational

Funder types: Industry

Identifiers

NCT05500066

20F-W-REVIVE-RM

Details and patient eligibility

About

This is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available AEQUALIS FLEX REVIVE shoulder system in both the anatomic and reversed configurations.

The purpose of this study is to collect data needed to satisfy the European Union (EU) Medical Device Regulation (MDR) clinical post-market surveillance (PMS) and reporting requirements, and to support future regulatory submissions and peer-reviewed publications on device performance and safety.

Full description

This is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up (PMCF) study. Data will be collected for the commercially available AEQUALIS FLEX REVIVE shoulder system in both the anatomic and reversed configurations.

The primary outcome measure will be measured by the average improvement in American Shoulder and Elbow Surgeons (ASES) score from baseline to 24 months.

Secondary outcome measures include patient reported outcome measures (PROMs) and standard radiographic findings, including, but not limited to: device migration, component breakage, and bone characteristics.

Device revision and adverse events (AEs) will be assessed annually throughout the study. Range of motion and radiographic imaging assessments will also be performed at Years 1, 2, 5 and 10 post-operation.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older at the time of the informed consent.
• Informed and willing to sign an informed consent form approved by IRB or Ethics Committee (EC) (when applicable).
• Willing and able to comply with the requirements of the study protocol.
• Considered for a candidate for shoulder arthroplasty using the study device
• Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements

Exclusion criteria

• Not able to comply with the study procedures based on the judgment of the assessor (e.g., cannot comprehend study questions, inability to keep scheduled assessment times)
• Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155 norm).
• Active local or systemic infection, sepsis, or osteomyelitis
• Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid (reassessed at time of surgery)
• Significant injury to the brachial plexus
• Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the components
• Neuromuscular disease (e.g., joint neuropathy)
• Patient with known allergy to one of the product materials
• Metabolic disorders which may impair bone formation
• Patient pregnancy
• Planned for two-stage surgery (reassessed at time of surgery)

Trial design

110 participants in 1 patient group

Aequalis Flex Revive Shoulder System

Description:

Commercially available shoulder system available in both anatomic and reversed configurations.

Treatment:

Device: Aequalis Flex Revive Shoulder System