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Clinical Trials in the USA / NCT05548972
Enrolling by invitation Not applicable

G7 Dual Mobility With Vivacit-E or Longevity PMCF

NCT05548972 · tracked via the Priya Life Science USA tracker
Sponsor
Zimmer Biomet
Phase
Not applicable
Started
2023-03-20
Last updated
2025-06-15

Condition(s) studied

Hip OsteoarthritisRheumatoid ArthritisJoint DiseasesAvascular NecrosisDislocation, HipFemoral Neck FracturesTrochanteric FracturesRevision Surgeries

Investigational drug(s) / intervention(s)

G7 Dual Mobility with Vivacit-E bearingG7 Dual Mobility Longevity bearing

G7 Dual Mobility with Vivacit-E bearing: hip arthroplasty with G7 Dual Mobility Vivacit-E bearing

G7 Dual Mobility Longevity bearing: hip arthroplasty with G7 Dual Mobility Longevity bearing

Study 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

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 (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

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Bowen Hefley Orthopedics Little Rock Arkansas
HCA HealthONE Orthopedic Specialists Denver Colorado
Jersey City Medical Center Jersey City New Jersey
Hospital for Special Surgery New York New York
The Cleveland Clinic Cleveland Ohio
Slocum Research & Education Foundation Eugene Oregon
UZ Leuven Leuven Belgium
Istituto San Siro Milan Italy
Pusan National University Yangsan Hospital Yangsan Gyeongsangnam
Chonnam National University Hwasun Hospital Hwasun Jeollanam-do

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 NCT05548972 on ClinicalTrials.gov ↗ ← All trials in the USA