AEQUALIS™ FLEX REVIVE™ Study (REVIVE)
Launched by STRYKER TRAUMA AND EXTREMITIES · Aug 11, 2022
Trial Information
Current as of July 23, 2025
Enrolling by invitation
Keywords
ClinConnect 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 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, componen...
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)
About Stryker Trauma And Extremities
Stryker Trauma and Extremities is a leading medical technology company dedicated to advancing innovative solutions for the treatment of trauma and orthopedic conditions. With a strong focus on research and development, Stryker is committed to improving patient outcomes through cutting-edge products and comprehensive clinical trials. The company leverages its expertise in trauma and extremity surgery to deliver safe, effective, and minimally invasive solutions that enhance surgical efficiency and promote rapid recovery. By collaborating with healthcare professionals and leveraging data-driven insights, Stryker Trauma and Extremities aims to set new standards in the field of musculoskeletal care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lexington, Kentucky, United States
Tampa, Florida, United States
Denver, Colorado, United States
Bradenton, Florida, United States
Patients applied
Trial Officials
Arthur de Gast, MD MSc PhD
Study Director
Stryker Trauma and Extremities
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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