AEQUALIS™ FLEX REVIVE™ Study (REVIVE)

NCT ID: NCT05500066

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-11
• Study Completion Date: 2036-01-03

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Aequalis Flex Revive Shoulder System

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

Aequalis Flex Revive Shoulder System

Intervention Type: DEVICE

The AEQUALIS FLEX REVIVE Shoulder System is intended for use as:

• A replacement of shoulder joints in primary anatomic or in primary reverse
• A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.

The system also allows for conversion from anatomic to reverse shoulder prosthesis in case of revision.

Interventions

Aequalis Flex Revive Shoulder System

The AEQUALIS FLEX REVIVE Shoulder System is intended for use as:

• A replacement of shoulder joints in primary anatomic or in primary reverse
• A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains.

The system also allows for conversion from anatomic to reverse shoulder prosthesis in case of revision.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Trauma and Extremities

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arthur de Gast, MD MSc PhD

Role: STUDY_DIRECTOR

Stryker Trauma and Extremities

Locations

Western Orthopaedics, P.C.

Denver, Colorado, United States

Coastal Orthopedics

Bradenton, Florida, United States

Foundation for Orthopaedic Research & Education

Tampa, Florida, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

20F-W-REVIVE-RM

Identifier Type: -

Identifier Source: org_study_id