Clinical Trial Finder

AEQUALIS™ FLEX REVIVE™ Study (REVIVE)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05500066
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Stryker Trauma GmbH
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Arthur de Gast, MD MSc PhD
Principal Investigator Affiliation Stryker Trauma and Extremities
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 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
Additional Details

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.

Arms & Interventions

Arms

: Aequalis Flex Revive Shoulder System

Commercially available shoulder system available in both anatomic and reversed configurations.

Interventions

Device: - Aequalis Flex Revive Shoulder System

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Western Orthopaedics, P.C., Denver, Colorado

Status

Address

Western Orthopaedics, P.C.

Denver, Colorado, 80218

Coastal Orthopedics, Bradenton, Florida

Status

Address

Coastal Orthopedics

Bradenton, Florida, 34212

Tampa, Florida

Status

Address

Foundation for Orthopaedic Research & Education

Tampa, Florida, 33637

Baptist Health Lexington, Lexington, Kentucky

Status

Address

Baptist Health Lexington

Lexington, Kentucky, 40503

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