G7 Dual Mobility With Vivacit-E or Longevity PMCF

Launched by ZIMMER BIOMET · Sep 16, 2022

Keywords

ClinConnect Summary

This global, multi-center study is following people who receive the G7 Dual Mobility Hip System as part of total hip replacement (both first-time and revision surgeries). It is not a randomized trial; surgeons and patients receive the device as part of routine care, and researchers will track safety and how well the implant works over time. There are two bearing options (Vivacit-E and Longevity), with Longevity enrolled only in the US and Vivacit-E used in many countries.

Who can take part? Adults aged 18 to 80 who need a total hip replacement or a revision and meet certain medical criteria (for example, hip osteoarthritis, avascular necrosis, hip dislocations, or certain hip fractures, among others). People with active joint infection, severe osteoporosis, pregnancy, or other conditions that might affect the implant’s success are usually not eligible. The study aims to enroll up to about 358 hips across up to 20 centers and follow them for up to 10 years. The main goals are to see whether the implant lasts and remains safe, while secondary goals include how much pain people have, how well they can function, and quality of life, with X-ray checks planned at around 5 years.

Gender

ALL

Eligibility criteria

• 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