G7 Dual Mobility With Vivacit-E or Longevity PMCF

Last updated: June 13, 2025
Sponsor: Zimmer Biomet
Overall Status: Active - Enrolling

Phase

N/A

Condition

Musculoskeletal Diseases

Dermatomyositis (Connective Tissue Disease)

Bone Diseases

Treatment

G7 Dual Mobility Longevity bearing

G7 Dual Mobility with Vivacit-E bearing

Clinical Study ID

NCT05548972
CMG2020-42H
  • Ages 18-80
  • All Genders

Study Summary

This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Dual Mobility Acetabular System when used with the Vivacit-E or Longevity polyethylene hip bearing and instrumentation in primary total and revision (total) hip arthroplasty

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is 18 to 80 years of age, inclusive

  • Patient is skeletally mature

  • Patient qualifies for (total) hip arthroplasty based on physical exam and medicalhistory including at least one of the following:

  • Non-inflammatory degenerative joint disease, including osteoarthritis andavascular necrosis

  • Rheumatoid arthritis

  • Dislocation risks

  • Correction of functional deformity

  • Treatment of non-union, femoral neck fracture, and trochanteric fractures ofthe proximal femur with head involvement, unmanageable by other techniques

  • Revision procedures where other treatment or devices have failed.

  • Patient is willing and able to complete scheduled follow-up evaluations as describedin the protocol and Informed Consent

  • Patient, or the patient's legally authorized representative (LAR), has participatedin the Informed Consent process and is willing and able to sign an IRB/EC approvedInformed Consent

Exclusion

Exclusion Criteria:

  • Patient is septic, has an active infection or has osteomyelitis at the affectedjoint

  • Patient has significant osteoporosis as defined by treating surgeon

  • Patient has metabolic disorder(s) which may impair bone formation

  • Patient has osteomalacia

  • Patient has distant foci of infections which may spread to the implant site

  • Patient has rapid joint destruction, marked bone loss or bone resorption apparent onpre-operative radiographs

  • Patient underwent contralateral THA within 3 months of planned index procedure orhas a contralateral THA planned within 3 months of the index procedure

  • Patient is undergoing simultaneous bilateral THA

  • Patient has vascular insufficiency, muscular atrophy at the implant site orneuromuscular disease which are likely to jeopardize the outcome of the surgery.

  • Patient has any concomitant disease which is likely to jeopardize the functioning orsuccess of the implant

  • Patient is known to be pregnant

  • The patient is in a vulnerable population group such as:

  • a prisoner

  • a known alcohol or drug abuser

  • mentally incompetent or unable to understand what participation in this studyentails

Study Design

Total Participants: 358
Treatment Group(s): 2
Primary Treatment: G7 Dual Mobility Longevity bearing
Phase:
Study Start date:
March 20, 2023
Estimated Completion Date:
August 31, 2037

Study Description

The G7 Dual Mobility construct offers dislocation resistance without the need to constrain the femoral head, providing stability and high range of motion. Dual Mobility systems decrease the risk of post-operative instability in high-risk patients in both primary and revision arthroplasties.

This study will enroll up to 358 hips globally, 179 for the Vivacit-E and 179 for the Longevity polyethylene bearings. From the 179 hips per bearing variant, the study will enroll 60 primary and 119 revision arthroplasty hips. The Longevity bearing variant will only be enrolled in the US, as it is not CE marked and unregistered in the APAC market. Vivacit-E bearings will be enrolled globally.

A maximum of 20 study centers will be selected globally. To minimize potential bias and to maximize our ability to assess inter-site differences, each study site will target maximum 24 primary hip arthroplasties and maximum 47 revision hip arthroplasties. Each site is encouraged to enroll both, primary and revision, subjects.

Connect with a study center

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Istituto San Siro

    Milano,
    Italy

    Site Not Available

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam 50612
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam-do 58128
    Korea, Republic of

    Site Not Available

  • Bowen Hefley Orthopedics

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • HCA HealthONE Orthopedic Specialists

    Denver, Colorado 80218
    United States

    Site Not Available

  • Jersey City Medical Center

    Jersey City, New Jersey 07302
    United States

    Site Not Available

  • Hospital for Special Surgery

    New York, New York 10021
    United States

    Site Not Available

  • The Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Slocum Research & Education Foundation

    Eugene, Oregon 97401
    United States

    Site Not Available

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