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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05500066
Recruitment Status : Not yet recruiting
First Posted : August 12, 2022
Last Update Posted : August 12, 2022
Sponsor:
Information provided by (Responsible Party):
Stryker Trauma GmbH

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.


Condition or disease Intervention/treatment
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 Device: Aequalis Flex Revive Shoulder System

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.

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AEQUALIS™ FLEX REVIVE™ Study (REVIVE)
Estimated Study Start Date : December 2, 2022
Estimated Primary Completion Date : January 6, 2028
Estimated Study Completion Date : January 3, 2036

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

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





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Patient Satisfaction [ Time Frame: through study completion, an average of 1 year ]
    Single subjective question "How satisfied are you with your shoulder?"

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05500066


Contacts
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Contact: Rebecca Gibson 919-915-4426 rebecca.gibson@stryker.com
Contact: Caryn Thompson 704-891-6540 caryn.thompson@stryker.com

Sponsors and Collaborators
Stryker Trauma GmbH
Investigators
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Study Director: Arthur de Gast, MD MSc PhD Stryker Trauma and Extremities
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Responsible Party: Stryker Trauma GmbH
ClinicalTrials.gov Identifier: NCT05500066    
Other Study ID Numbers: 20F-W-REVIVE-RM
First Posted: August 12, 2022    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Stryker Trauma GmbH:
Total Shoulder Replacement
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Additional relevant MeSH terms:
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Arthritis
Osteoarthritis
Necrosis
Rotator Cuff Injuries
Humeral Fractures
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Arm Injuries
Fractures, Bone