G7 Freedom Constrained Vivacit-E Liners

Last updated: October 16, 2025
Sponsor: Zimmer Biomet
Overall Status: Active - Enrolling

Phase

N/A

Condition

Arthritis And Arthritic Pain

Osteomyelitis

Dermatomyositis (Connective Tissue Disease)

Treatment

Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners

Clinical Study ID

NCT05587244
CMG2021-36H
  • Ages 18-80
  • All Genders

Study Summary

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary 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 unilateral total hip arthroplasty based on physical exam andmedical history including at least one of the following:

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

  • Rheumatoid arthritis

  • High risk for dislocation

  • Undergoing revision hip arthroplasty

  • Correction of functional deformity

  • In need of treatment of non-union, femoral neck fracture, and trochantericfractures of the proximal femur with head involvement, unmanageable by othertechniques

  • 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, has participated in theInformed Consent process and is willing and able to sign an IRB approved informedconsent

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 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 might jeopardize the outcome of the surgery.

  • In the opinion of the investigator, patient has any concomitant disease which islikely to jeopardize the functioning or success of the implant

  • Patient is known to be pregnant

  • The patient is in the 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: 202
Treatment Group(s): 1
Primary Treatment: Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners
Phase:
Study Start date:
May 08, 2023
Estimated Completion Date:
December 31, 2038

Study Description

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.

The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal of the study device and will be determined using the Kaplan-Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to the implant, instrumentation and/or procedure should be specified.

The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).

The G7 Vivacit-E Freedom Constrained Liner is indicated for use (per IFU) as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham 4049979, Alabama 4829764 35205
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • University of Southern California

    Los Angeles 5368361, California 5332921 90033
    United States

    Site Not Available

  • University of Florida Board of Trustees

    Gainesville, Florida 32611
    United States

    Site Not Available

  • University of Florida Board of Trustees

    Gainesville 4156404, Florida 4155751 32611
    United States

    Site Not Available

  • Jersey City Medical Center, Inc

    Livingston, New Jersey 07039
    United States

    Site Not Available

  • Jersey City Medical Center, Inc

    Livingston 5100572, New Jersey 5101760 07039
    United States

    Site Not Available

  • The Ohio State University

    Columbus, Ohio 43201
    United States

    Site Not Available

  • The Ohio State University

    Columbus 4509177, Ohio 5165418 43201
    United States

    Site Not Available

  • TOA Research Foundation

    Knoxville, Tennessee 37923
    United States

    Site Not Available

  • TOA Research Foundation

    Knoxville 4634946, Tennessee 4662168 37923
    United States

    Site Not Available

  • The University of Texas Health Science Center of Houston

    Houston, Texas 77030
    United States

    Site Not Available

  • Medical City Plano

    Plano, Texas 75075
    United States

    Site Not Available

  • The University of Texas Health Science Center of Houston

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Medical City Plano

    Plano 4719457, Texas 4736286 75075
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Site Not Available

  • University of Utah

    Salt Lake City 5780993, Utah 5549030 84108
    United States

    Site Not Available

  • West Virginia University

    Morgantown, West Virginia 26506
    United States

    Site Not Available

  • West Virginia University

    Morgantown 4815352, West Virginia 4826850 26506
    United States

    Site Not Available

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