AEQUALIS™ FLEX REVIVE™ Study (REVIVE)

• Conditions: Osteoarthritis Shoulder; Rotator Cuff Tears; Rheumatoid Arthritis; Traumatic Arthritis; Fractures Humerus; Avascular Necrosis; Correction of Functional Deformity; Revision of Other Devices if Sufficient Bone Stock Remains
• Interventions: Device: Aequalis Flex Revive Shoulder System

• Registration Number: NCT05500066
• Lead Sponsor: Stryker Trauma and Extremities

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.

Study Timeline

• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-11
• Study First Posted: 2022-08-12
• Study Start: 2023-01-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20
• Primary Completion: 2028-01-06
• Study Completion: 2036-01-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 110

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aequalis Flex Revive Shoulder System	Aequalis Flex Revive Shoulder System	Commercially available shoulder system available in both anatomic and reversed configurations.

Primary Outcome Measures

Name	Time	Method
Average Improvement from Baseline to last follow-up visit in ASES Score	24 Month	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

Secondary Outcome Measures

Name	Time	Method
SANE	through study completion, an average of 1 year	Single question that asks the patient to rate their shoulder on a scale from 0 to 100, where 100 is normal.
EQ 5-D	through study completion, an average of 1 year	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.
Patient Satisfaction	through study completion, an average of 1 year	Single subjective question "How satisfied are you with your shoulder?"
Radiographic Findings	Baseline, 1 year, 2 year, 5 year and 10 year	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.
Constant Score	through study completion, an average of 1 year	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.

Trial Locations

Locations (4)

Western Orthopaedics, P.C.; 🇺🇸 Denver, Colorado, United States

Foundation for Orthopaedic Research & Education; 🇺🇸 Tampa, Florida, United States

Coastal Orthopedics; 🇺🇸 Bradenton, Florida, United States

Baptist Health Lexington; 🇺🇸 Lexington, Kentucky, United States