Rheumatoid Arthritis Clinical Trial
— REVIVEOfficial title:
AEQUALIS™ FLEX REVIVE™ Study (REVIVE)
Verified date | February 2024 |
Source | Stryker Trauma GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 110 |
Est. completion date | January 3, 2036 |
Est. primary completion date | January 6, 2028 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Coastal Orthopedics | Bradenton | Florida |
United States | Western Orthopaedics, P.C. | Denver | Colorado |
United States | Baptist Health Lexington | Lexington | Kentucky |
United States | Foundation for Orthopaedic Research & Education | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Stryker Trauma GmbH |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Patient Satisfaction | Single subjective question "How satisfied are you with your shoulder?" | through study completion, an average of 1 year | |
Secondary | 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 |
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