G7 Dual Mobility With Vivacit-E or Longevity PMCF

NCT05548972 | Enrolling By Invitation FDA Device

• 1 other identifier: CMG2020-42H
• Study Type: interventional
• Target: 358
• Locations: 4 countries
• Sites: 10

Brief 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

Conditions

Hip Osteoarthritis; Rheumatoid Arthritis; Joint Diseases; Avascular Necrosis; Dislocation, Hip; Femoral Neck Fractures; Trochanteric Fractures; Revision Surgeries

Keywords

Total Hip arthroplasty; Revision Hip arthroplasty; Medical device; Safety; Performance; Clinical benefit; G7 Dual Mobility

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Modified Harris Hip Score

  10 years

• Oxford Hip Score

  10 years

• EQ-5D-5L

  10 years

• Radiographic Assessment

  5 years

Study Arms (4)

G7 Dual Mobility with Vivacit-E polyethylene bearing in primary THA

OTHER

Subjects in need of a total hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 60)

Device: G7 Dual Mobility with Vivacit-E bearing

G7 Dual Mobility with Vivacit-E polyethylene bearing in revision (total) hip arthroplasty

OTHER

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

G7 Dual Mobility with Longevity polyethylene bearing in primary THA

OTHER

Subjects in need of a total hip arthroplasty who meet inclusion/exclusion criteria(anticipated enrollment: 60)

Device: G7 Dual Mobility Longevity bearing

G7 Dual Mobility with Vivacit-E Longevity bearing in revision (total) hip arthroplasty

OTHER

Subjects in need of a revision (total) hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 119)

Device: G7 Dual Mobility Longevity bearing

Interventions

G7 Dual Mobility with Vivacit-E bearing DEVICE

hip arthroplasty with G7 Dual Mobility Vivacit-E bearing

G7 Dual Mobility with Vivacit-E polyethylene bearing in primary THA; G7 Dual Mobility with Vivacit-E polyethylene bearing in revision (total) hip arthroplasty

G7 Dual Mobility Longevity bearing DEVICE

hip arthroplasty with G7 Dual Mobility Longevity bearing

G7 Dual Mobility with Longevity polyethylene bearing in primary THA; G7 Dual Mobility with Vivacit-E Longevity bearing in revision (total) hip arthroplasty

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (10)

Bowen Hefley Orthopedics

Little Rock, Arkansas, 72205, United States

Location

HCA HealthONE Orthopedic Specialists

Denver, Colorado, 80218, United States

Location

Jersey City Medical Center

Jersey City, New Jersey, 07302, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Slocum Research & Education Foundation

Eugene, Oregon, 97401, United States

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Istituto San Siro

Milan, Italy

Location

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam, 50612, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Arthritis, Rheumatoid; Joint Diseases; Osteonecrosis; Hip Dislocation; Femoral Neck Fractures; Hip Fractures

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Joint Dislocations; Wounds and Injuries; Hip Injuries; Femoral Fractures; Fractures, Bone; Leg Injuries

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 22, 2022
• Study Start: March 20, 2023
• Primary Completion (Estimated): January 1, 2037
• Study Completion (Estimated): August 1, 2037
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2); US (6); BE (1); IT (1)