AEQUALIS™ FLEX REVIVE™ Study (REVIVE)

Study Overview
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Brief Summary
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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
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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.

Official Title
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AEQUALIS™ FLEX REVIVE™ Study (REVIVE)

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

Intervention / Treatment
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* Device: Aequalis Flex Revive Shoulder System


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aequalis Flex Revive Shoulder System<br>Commercially available shoulder system available in both anatomic and reversed configurations. | Device: Aequalis Flex Revive Shoulder System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Improvement from Baseline to last follow-up visit in ASES Score | ASES Score = American Shoulder and Elbow Surgeons Score, 11 items with total score reported out of 100 measuring pain and activity of patient's evaluated shoulder where lower scores indicate more pain and less function | 24 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Score | A score based on a 100-point scale determined by objective measurements made by the physician in the clinic and subjective values based on pain and activities of daily living reported by the patient. | through study completion, an average of 1 year | 
| SANE | Single question that asks the patient to rate their shoulder on a scale from 0 to 100, where 100 is normal. | through study completion, an average of 1 year | 
| EQ 5-D | Consists of a 5-question measure where patients rate their health today on a 5-point scale on a 5-dimension scale and a visual analogue scale to measure overall health status. | through study completion, an average of 1 year | 
| Patient Satisfaction | Single subjective question How satisfied are you with your shoulder? | through study completion, an average of 1 year | 
| Radiographic Findings | Images will be reviewed by a single orthopedic surgeon to assess for standard radiographic findings, including, but not limited to: device migration, component breakage, and bone characteristics. | Baseline, 1 year, 2 year, 5 year and 10 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Shoulder Replacement, Osteoarthritis, Joint Diseases, Musculoskeletal Diseases