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Clinical Trials in the USA / NCT05587244
Enrolling by invitation Not applicable

G7 Freedom Constrained Vivacit-E Liners

NCT05587244 · tracked via the Priya Life Science USA tracker
Sponsor
Zimmer Biomet
Phase
Not applicable
Started
2023-05-08
Last updated
2025-10-20

Condition(s) studied

Osteoarthritis, HipRheumatoid ArthritisNon-Union FractureTrochanteric FracturesFemoral Neck FracturesAvascular NecrosisDislocation, Hip

Investigational drug(s) / intervention(s)

Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners

Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners: Primary and/or Revision total hip arthroplasty with the G7 Freedom Constrained Vivacit-E Liners

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 and medical history including at least one of the following: * Non-inflammatory degenerative joint disease, including osteoarthritis and avascular 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 trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques * 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, has participated in the Informed Consent process and is willing and able to sign an IRB 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 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 might jeopardize the outcome of the surgery. * In the opinion of the investigator, 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 the 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

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
University of Southern California Los Angeles California
University of Florida Board of Trustees Gainesville Florida
Jersey City Medical Center, Inc Livingston New Jersey
The Ohio State University Columbus Ohio
TOA Research Foundation Knoxville Tennessee
The University of Texas Health Science Center of Houston Houston Texas
Medical City Plano Plano Texas
University of Utah Salt Lake City Utah
West Virginia University Morgantown West Virginia

More Zimmer Biomet trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05587244 on ClinicalTrials.gov ↗ ← All trials in the USA