Clinical Trial Finder

G7 Dual Mobility With Vivacit-E or Longevity PMCF

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05548972
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Zimmer Biomet
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Hassan Achakri
Principal Investigator Affiliation Zimmer Biomet
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Enrolling by invitation
Countries Belgium, Italy, Korea, Republic of, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

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.

Arms & Interventions

Arms

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)

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)

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)

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)

Interventions

Device: - G7 Dual Mobility with Vivacit-E bearing

hip arthroplasty with G7 Dual Mobility Vivacit-E bearing

Device: - G7 Dual Mobility Longevity bearing

hip arthroplasty with G7 Dual Mobility Longevity bearing

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bowen Hefley Orthopedics, Little Rock, Arkansas

Status

Address

Bowen Hefley Orthopedics

Little Rock, Arkansas, 72205

Jersey City Medical Center, Jersey City, New Jersey

Status

Address

Jersey City Medical Center

Jersey City, New Jersey, 07302

Slocum Research & Education Foundation, Eugene, Oregon

Status

Address

Slocum Research & Education Foundation

Eugene, Oregon, 97401

International Sites

UZ Leuven, Leuven, Belgium

Status

Address

UZ Leuven

Leuven, , 3000

Istituto San Siro, Milano, Italy

Status

Address

Istituto San Siro

Milano, ,

Yangsan, Gyeongsangnam, Korea, Republic of

Status

Address

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam, 50612

Hwasun, Jeollanam-do, Korea, Republic of

Status

Address

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 58128

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