Baptist Health Lexington

Brent Joseph Morris

Principal Investigator

Dee Mallory

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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.
Eligibility Criteria

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)