NCT05548972

G7 Dual Mobility With Vivacit-E or Longevity PMCF

Enrolling by Invitation
NAAges 18–80InterventionalTreatment
Zimmer Biomet
~358 participants
Updated 2025-06-15 on ClinicalTrials.gov
What's tested:G7 Dual Mobility with Vivacit-E bearingG7 Dual Mobility Longevity bearing

At a glance

Recruiting sites
0 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Survival of the implant system
Measured over 10 years
+1 more outcome measured
Hip Osteoarthritis
Rheumatoid Arthritis
Joint Diseases
Avascular Necrosis
Dislocation, Hip
Femoral Neck Fractures
Trochanteric Fractures
Revision Surgeries
10 sites across 10 states
Arkansas1
Colorado1
New Jersey1
New York1
Ohio1
Oregon1
Belgium1
Italy1
  • Hassan Achakri · STUDY_DIRECTOR · Zimmer Biomet

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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
  • Survival of the implant system10 years

    Survival of the implant system based on removal of the study device

  • Safety of the implant system10 years

    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.