AEQUALIS™ FLEX REVIVE™ Study (REVIVE)

N/AEnrolling By InvitationNCT05500066

Stryker Trauma and Extremities110 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

110

Conditions

Rheumatoid Arthritis Osteoarthritis Shoulder Fractures Humerus Avascular Necrosis

Interventions

Aequalis Flex Revive Shoulder SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (4)

Western Orthopaedics, P.C.

Denver, Colorado, United States

Coastal Orthopedics

Bradenton, Florida, United States

Foundation for Orthopaedic Research & Education

Tampa, Florida, United States

Baptist Health Lexington

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

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

Time frame: 24 Month

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: through study completion, an average of 1 year

Patient Satisfaction

Single subjective question "How satisfied are you with your shoulder?"

Time frame: 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.

Time frame: Baseline, 1 year, 2 year, 5 year and 10 year