Follow-up study of the G7 hip implant with Vivacit-E or Longevity bearing
Follows adults with hip disease who receive the G7 dual mobility hip implant.
Plain-language title generated from the registry record
Registry title: G7 Dual Mobility With Vivacit-E or Longevity PMCF
Key facts
- Where
- Milan, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05548972, who can take part
Where in Italy
- Istituto San SiroMilan, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Zimmer Biomet
- Trial code
- NCT05548972
- Record updated
- 15 June 2025
- Original description
This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Dual Mobility Acetabular System when used with the Vivacit-E or Longevity polyethylene hip bearing and instrumentation in primary total and revision (total) hip arthroplastyRead full original descriptionShow less
Global, Multicenter and Prospective Post-Market Clinical Follow-Up Study of the G7® Dual Mobility Acetabular System With Vivacit-E® or Longevity® Poly Bearing & Instrumentation
This study is a global, multi-center, prospective, non-controlled, non-randomized, post-market clinical follow-up study. The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Dual Mobility Acetabular System when used with the Vivacit-E or Longevity polyethylene hip bearing and instrumentation in primary total and revision (total) hip arthroplasty
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 has any concomitant disease which is likely to jeopardize the functioning or success of the implant; 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; Patient is septic, has an active infection or has osteomyelitis at the affected joint; Patient has metabolic disorder(s) which may impair bone formation; Patient has distant foci of infections which may spread to the implant site; 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 significant osteoporosis as defined by treating surgeon; Patient has osteomalacia; 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 is known to be pregnant.