G7 Freedom Constrained Vivacit-E Liners

Launched by ZIMMER BIOMET · Oct 17, 2022

Keywords

ClinConnect Summary

This is a multicenter, long-term study looking at how well and how safely the G7 Freedom Constrained Vivacit-E acetabular liner (a part used inside certain hip replacement implants) performs in people having total hip arthroplasty. It’s not a randomized trial; it follows a group of patients who receive the liner to see if the implant stays in place for up to 10 years and to monitor safety, patient-reported outcomes (like pain and function), and X-ray findings over time.

Eligible people are adults aged 18 to 80 who need a unilateral hip replacement (either a first-time replacement or a revision) and have conditions such as osteoarthritis of the hip, avascular necrosis, rheumatoid arthritis, or a high risk of hip dislocation. They should be able to complete follow-up visits and consent to participate. Exclusions include active infection at the hip, severe osteoporosis or certain other bone/metabolic issues, pregnancy, or conditions likely to jeopardize the implant’s success. Participants can expect up to 10 years of follow-up with safety checks for adverse events, patient questionnaires about pain and daily function, and imaging studies at certain time points (including 5 years) to look for changes in the hip joint. As of now, the study is enrolling and has not yet reported results.

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