Clinical trial NCT05500066: AEQUALIS™ FLEX REVIVE™ Study (REVIVE)
Official title: AEQUALIS™ FLEX REVIVE™ Study (REVIVE)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Rheumatoid Arthritis
Osteoarthritis Shoulder
Fractures Humerus
Avascular Necrosis
Correction of Functional Deformity
Traumatic Arthritis
Revision of Other Devices if Sufficient Bone Stock Remains
Rotator Cuff Tears
Keywords: Total Shoulder Replacement
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2022-08-12
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 110 subjects are to be enrolled in this clinical investigation. Subjects participating in this clinical investigation will be recruited from the investigator's standard subject population, where all subjects presenting for an anatomic or reversed total shoulder arthroplasty will be evaluated for clinical investigation participation based on the eligibility criteria.

Brief 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 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: 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.

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)

Primary outcomes:
measure: Average Improvement from Baseline to last follow-up visit in ASES Score
timeFrame: 24 Month
Secondary outcomes:
measure: Constant Score
timeFrame: through study completion, an average of 1 year
measure: SANE
timeFrame: through study completion, an average of 1 year
measure: EQ 5-D
timeFrame: through study completion, an average of 1 year
measure: Patient Satisfaction
timeFrame: through study completion, an average of 1 year
measure: Radiographic Findings
timeFrame: Baseline, 1 year, 2 year, 5 year and 10 year
Other outcomes:
Locations:
city: Denver
country: United States
facility: Western Orthopaedics, P.C.
state: Colorado
city: Bradenton
country: United States
facility: Coastal Orthopedics
state: Florida
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research & Education
state: Florida
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
Study officials:
affiliation: Stryker Trauma and Extremities
name: Arthur de Gast, MD MSc PhD
role: STUDY_DIRECTOR
References: