G7 Dual Mobility With Vivacit-E or Longevity PMCF

Global, Multicenter and Prospective Post-Market Clinical Follow-Up Study of the G7® Dual Mobility Acetabular System With Vivacit-E® or Longevity® Poly Bearing & Instrumentation

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Joint Diseases; Rheumatoid Arthritis; Avascular Necrosis; Femoral Neck Fractures; Hip Osteoarthritis; Dislocation, Hip; Trochanteric Fractures; Revision Surgeries
• Intervention / Treatment: Device: G7 Dual Mobility with Vivacit-E bearing; Device: G7 Dual Mobility Longevity bearing

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 358
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven
• Italy
  • Milano, Italy
    • Istituto San Siro
• Korea, Republic of
  • Gyeongsangnam
    • Yangsan, Gyeongsangnam, Korea, Republic of, 50612
      • Pusan National University Yangsan Hospital
  • Jeollanam-do
    • Hwasun, Jeollanam-do, Korea, Republic of, 58128
      • Chonnam National University Hwasun Hospital
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Bowen Hefley Orthopedics
  • Colorado
    • Denver, Colorado, United States, 80218
      • HCA HealthONE Orthopedic Specialists
  • New Jersey
    • Jersey City, New Jersey, United States, 07302
      • Jersey City Medical Center
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Slocum Research & Education Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Patients who suffer from severe hip pain and disability requiring primary total or revision hip arthroplasty according to the latest Instructions for Use (IFU) and who meet all of the inclusion and none of the exclusion criteria.

Description

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 medical history including at least one of the following:

  • Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
  • Rheumatoid arthritis
  • Dislocation risks
  • Correction of functional deformity
  • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the 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 described in the protocol and Informed Consent
• Patient, or the patient's legally authorized representative (LAR), has participated in the Informed Consent process and is willing and able to sign an IRB/EC approved Informed Consent

Exclusion Criteria:

• Patient is septic, has an active infection or has osteomyelitis at the affected joint
• 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 on pre-operative radiographs
• Patient underwent contralateral THA within 3 months of planned index procedure or has 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 or neuromuscular disease which are likely to jeopardize the outcome of the surgery.
• Patient has any concomitant disease which is likely to jeopardize the functioning or success 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 study entails

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: G7 Dual Mobility with Vivacit-E polyethylene bearing in primary THA; Subjects in need of a total hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 60)	Device: G7 Dual Mobility with Vivacit-E bearing; hip arthroplasty with G7 Dual Mobility Vivacit-E bearing
Other: G7 Dual Mobility with Vivacit-E polyethylene bearing in revision (total) hip arthroplasty; Subjects in need of a revision (total) hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 119)	Device: G7 Dual Mobility with Vivacit-E bearing; hip arthroplasty with G7 Dual Mobility Vivacit-E bearing
Other: G7 Dual Mobility with Longevity polyethylene bearing in primary THA; Subjects in need of a total hip arthroplasty who meet inclusion/exclusion criteria(anticipated enrollment: 60)	Device: G7 Dual Mobility Longevity bearing; hip arthroplasty with G7 Dual Mobility Longevity bearing
Other: G7 Dual Mobility with Vivacit-E Longevity bearing in revision (total) hip arthroplasty; Subjects in need of a revision (total) hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 119)	Device: G7 Dual Mobility Longevity bearing; hip arthroplasty with G7 Dual Mobility Longevity bearing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of the implant system	Survival of the implant system based on removal of the study device	10 years
Safety of the implant system	Safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Harris Hip Score	The modified Harris Hip Score measures pain, function and functional activities using a self assessment. The overall score runs from 0-100 with 100 representing the best outcome.	10 years
Oxford Hip Score	The Oxford Hip Score measures pain and function using a self assessment. The overall score runs from 0-48 with 48 representing the best outcome.	10 years
EQ-5D-5L	The EQ-5D-5L measures the quality of life using a self assessment. The questionnaire includes 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	10 years
Radiographic Assessment	X-ray evaluation to find significant radiographic findings such as radiolucency, osteolysis, atrophy, hypertrophy, component migration, device fracture, heterotopic ossification, etc	5 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hassan Achakri, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Estimated): January 1, 2037
• Study Completion (Estimated): August 1, 2037

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Performance; Total Hip arthroplasty; Medical device; Revision Hip arthroplasty; Clinical benefit; G7 Dual Mobility
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Pathologic Processes; Arthritis; Rheumatic Diseases; Leg Injuries; Osteoarthritis; Femoral Fractures; Hip Injuries; Joint Dislocations; Joint Diseases; Necrosis; Fractures, Bone; Hip Fractures; Osteoarthritis, Hip; Femoral Neck Fractures; Hip Dislocation
• Other Study ID Numbers: CMG2020-42H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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