AEQUALIS™ FLEX REVIVE™ Study (REVIVE)

Launched by STRYKER TRAUMA AND EXTREMITIES · Aug 11, 2022

Keywords

ClinConnect Summary

This is an international, single-arm, post-market study of the AEQUALIS FLEX REVIVE Shoulder System used in total shoulder replacement, available in both the standard (anatomic) and reverse configurations. The main goal is to collect safety and performance data for this device to support EU post-market surveillance. The primary measure will be the average improvement in the ASES score (a combined pain and function score for the shoulder) from before surgery to 24 months after surgery. Secondary measures include several patient-reported outcomes (like a quick 0–100 shoulder rating, a general health survey, and overall satisfaction) and radiographs to check the implant over time. Doctors will also track any adverse events and whether a revision surgery is needed, with imaging and range-of-motion checks at specified years (1, 2, 5, and 10).

Who may be eligible and what to expect: about 110 adults (18 or older) who are planned to have shoulder replacement with this device can participate if they can give informed consent and will follow the study protocol. Key inclusion criteria include the ability to comply with follow-up visits and meeting indications for using the device. Exclusion criteria include active infection, poor bone quality, significant nerve injury, or other factors that would make participation inappropriate. The study is sponsored by Stryker and conducted at several U.S. sites; it is not randomized and does not share individual patient data. Participants will have annual safety checks, outcome surveys, and imaging to monitor the implant over time, with outcomes tracked through at least year 10.

Gender

ALL

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)