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G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study

NCT04754087 · Zimmer Biomet
In plain English

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Official title
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
About this study
The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal or intended removal of the study device and will be determined using 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 either implant or instrumentation should be specified. The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).
Eligibility 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.
Study design
Enrollment target: 300 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2021-07-07
Estimated completion: 2033-12-31
Last updated: 2025-06-18
Interventions
Device: Vivacit-E and Longevity (HXLPE) Liners
Primary outcomes
  • Survival of the study device (liner); whether or not it is still implanted in the subject (At 10 years)
  • Adverse Event (safety) (At 10 years)
Sponsor
Zimmer Biomet · industry
Contacts & investigators
ContactWendy J Hatcher · contact · wendy.hatcher@zimmerbiomet.com · 574-549-4281
ContactLynsey Boyle · contact · lynsey.boyle@zimmerbiomet.com · 412-552-7111
InvestigatorHillary Overholser · study_director, Zimmer Biomet
All locations (11)
Colorado Joint ReplacementActive Not Recruiting
Denver, Colorado, United States
South Bend OrthopaedicsActive Not Recruiting
South Bend, Indiana, United States
Duke University Medical CenterActive Not Recruiting
Durham, North Carolina, United States
Slocum Center for Orthopedics & Sports MedicineActive Not Recruiting
Eugene, Oregon, United States
Oregon Health and Science UniversityActive Not Recruiting
Portland, Oregon, United States
University of Utah HealthActive Not Recruiting
Salt Lake City, Utah, United States
Copenhagen University Hospital HvidovreRecruiting
Hvidovre, Denmark
Zuyderland HospitalActive Not Recruiting
Geleen, Netherlands
OCON HengeloRecruiting
Hengelo, Netherlands
Skane University HospitalRecruiting
Lund, Sweden
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth HospitalRecruiting
Bournemouth, UK, United Kingdom
G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study · TrialPath