Evaluation of G7 Acetabular System with Vivacit-E or Longevity Liner for Hip Replacement
Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the G7 Acetabular System With Vivacit-E and Longevity Highly Crosslinked Polyethylene (HXLPE) Liners & Instrumentation
This study is testing if a new hip replacement system using specific liners is safe and effective for patients over a 10-year period.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zimmer Biomet Industry-sponsored |
| Locations | 11 sites (Denver, Colorado and 10 other locations) |
| Trial ID | NCT04754087 on ClinicalTrials.gov |
What this trial studies
This study aims to confirm the long-term safety and performance of the G7 Acetabular Shells used with Vivacit-E and Longevity HXLPE liners in patients undergoing primary and revision total hip arthroplasty. The primary endpoint focuses on the survival of the implant system over a 10-year period, assessed through the Kaplan Meier method. Safety will be monitored by tracking adverse events related to the implant or instrumentation, while secondary endpoints will evaluate patient-reported outcomes and radiographic results.
Who should consider this trial
Good fit: Ideal candidates include adults with noninflammatory degenerative joint diseases, rheumatoid arthritis, or those requiring revision procedures for hip issues.
Not a fit: Patients with osteoporosis or metabolic disorders that may impair their ability to support total hip arthroplasty will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved long-term outcomes and safety for patients undergoing hip replacement surgeries.
How similar studies have performed: Other studies have shown promising results with similar implant systems, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient must be a legal adult who has reached full skeletal maturity. * Patient must be treated for one of the following indications: * Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis * Rheumatoid arthritis * 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 must be able and willing to complete the protocol required follow-up visits. * Patient must be able and willing to sign the Institutional Review Board or Ethics Committee (IRB/EC) approved informed consent. Exclusion Criteria: * Patient presents with osteoporosis, which in the opinion of the Principal Investigator, may limit the subject's ability to support total hip arthroplasty using the study device. * Patient has a metabolic disorder that may impair bone formation. * Patient has osteomalacia. * Patient has distant foci of infections which may spread to the implant site or patient with infection, sepsis or osteomyelitis. * Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram. * Patient has a vascular insufficiency, muscular atrophy, or neuromuscular disease * Patient is a prisoner. * Patient is a current alcohol or drug abuser. * Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions. * Patient is pregnant.
Where this trial is running
Denver, Colorado and 10 other locations
- Colorado Joint Replacement — Denver, Colorado, United States (Active_not_recruiting)
- South Bend Orthopaedics — South Bend, Indiana, United States (Active_not_recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Active_not_recruiting)
- Slocum Center for Orthopedics & Sports Medicine — Eugene, Oregon, United States (Active_not_recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Active_not_recruiting)
- University of Utah Health — Salt Lake City, Utah, United States (Active_not_recruiting)
- Copenhagen University Hospital Hvidovre — Hvidovre, Denmark (Recruiting)
- Zuyderland Hospital — Geleen, Netherlands (Active_not_recruiting)
- OCON Hengelo — Hengelo, Netherlands (Recruiting)
- Skane University Hospital — Lund, Sweden (Recruiting)
- The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital — Bournemouth, UK, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Wendy J Hatcher
- Email: wendy.hatcher@zimmerbiomet.com
- Phone: 574-549-4281
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.