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Email CoordinatorOverview:
Revive: AEQUALIS™ FLEX REVIVE™ Study (REVIVE)
Inclusion Criteria:
To be included, patients must meet the following 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:
Patients will be excluded from the study if they meet any of the following 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 5 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)