AEQUALIS™ FLEX REVIVE™ Study (REVIVE) (REVIVE)

• ClinicalTrials.gov Identifier: NCT05500066
• Recruitment Status: Enrolling by invitation
• First Posted: August 12, 2022
• Last Update Posted: February 20, 2024
• Sponsor: Stryker Trauma GmbH
• Information provided by (Responsible Party): Stryker Trauma GmbH

Tracking Information

• First Submitted Date: August 4, 2022
• First Posted Date: August 12, 2022
• Last Update Posted Date: February 20, 2024
• Actual Study Start Date: January 11, 2023
• Estimated Primary Completion Date: January 6, 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 11, 2022)

Average Improvement from Baseline to last follow-up visit in ASES Score [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 11, 2022)

• Constant Score [ Time Frame: 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.
• SANE [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: through study completion, an average of 1 year ]
  Single subjective question "How satisfied are you with your shoulder?"
• Radiographic Findings [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: AEQUALIS™ FLEX REVIVE™ Study (REVIVE)
• Official Title: AEQUALIS™ FLEX REVIVE™ Study (REVIVE)

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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• 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

Intervention

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.

Study Groups/Cohorts

Aequalis Flex Revive Shoulder System

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

Intervention: Device: Aequalis Flex Revive Shoulder System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: August 11, 2022): 110
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 3, 2036
• Estimated Primary Completion Date: January 6, 2028 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05500066
• Other Study ID Numbers: 20F-W-REVIVE-RM
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Stryker Trauma GmbH
• Original Responsible Party: Same as current
• Current Study Sponsor: Stryker Trauma GmbH
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Arthur de Gast, MD MSc PhD; Stryker Trauma and Extremities

• PRS Account: Stryker Trauma GmbH
• Verification Date: February 2024