G7 Freedom Constrained Vivacit-E Liners

Launched by ZIMMER BIOMET · Oct 17, 2022

Keywords

ClinConnect 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.

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 ...

Gender

ALL

Eligibility criteria

• 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