NCT05587244

G7 Freedom Constrained Vivacit-E Liners

Enrolling by Invitation
NAAges 18–80InterventionalTreatment
Zimmer Biomet
~202 participants
Updated 2025-10-20 on ClinicalTrials.gov
What's tested:Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners

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 study device
Measured over 10 years
Osteoarthritis, Hip
Rheumatoid Arthritis
Non-Union Fracture
Trochanteric Fractures
Femoral Neck Fractures
Avascular Necrosis
Dislocation, Hip
10 sites across 9 states
Texas2
Alabama1
California1
Florida1
New Jersey1
Ohio1
Tennessee1
Utah1
  • Hillary Overholser · 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 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

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
  • Survival of the study device10 years

    Survival (whether or not it is still implanted in the subject) determined using Kaplan Meier method.