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Active, not recruiting Observational

Prospective G7 Dual Mobility Total Hip PMCF

NCT03308929 · tracked via the Priya Life Science Mexico tracker
Phase
Observational
Started
2017-02-28
Last updated
2026-10-05

Condition(s) studied

Clinical OutcomesFunctional OutcomesRadiological OutcomesSurvivorshipSafety

Investigational drug(s) / intervention(s)

G7 Dual Mobility hip

G7 Dual Mobility hip: Total hip arthroplasty and implantation of the G7 device

Study summary

This is a prospective multi-center clinical evaluation following recipients of the G7 Dual Mobility hip device. The primary objective is to characterize survivorship of the G7 hip at five years post-index procedure. Secondary objectives include documentation of clinical outcomes, safety and radiographic data.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Patients who are undergoing revision hip arthroplasty -OR * Patients who are undergoing total hip arthroplasty (THA) for the correction of a functional deformity \- OR * Patients in need of treatment of femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques \- OR * Patients suffer from substantial pain and/or limited function, are appropriate for a primary total hip arthroplasty, considered at high risk for dislocation and have one of the following: * Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis * Rheumatoid arthritis * Decision to have a G7 Dual Mobility system implanted was made independently and prior to recruitment into study * From 18 to 80 years of age (inclusive) at time of procedure * BMI equal to or less than 35 * Unilateral total hip replacement * Willing and able to comply with the study procedures Exclusion Criteria: * Patients undergoing total hip arthroplasty following non-union of previous surgically treated fracture. * Infection, sepsis or osteomyelitis at the affected joint * Significant osteoporosis as defined by treating surgeon * Metabolic disorders which may impair bone formation * Osteomalacia * Distant foci of infections which may spread to the implant site * Rapid joint destruction, marked bone loss or bone resorption on preoperative radiographs * Underwent contralateral THA within 12 months of planned index procedure * Contralateral THA planned within 12 months of index procedure * Vascular insufficiency, muscular atrophy at the implant site or neuromuscular disease * The patient is * A prisoner * A known alcohol or drug abuser * The patient has any concomitant disease which is likely to jeopardize the functioning or success of the implant * The patient is known to be pregnant * The patient has a known sensitivity or allergy to one or more of the implanted materials, inducing but not limited to chromium, cobalt, and ceramic

Primary outcome measure(s)

  • Survivorship of the study device — 5 years
    This is assessed by removal of the study device from the patient for any reason, including failure of the device, infection, or traumatic injury.

Trial sites (6)

FacilityCityRegionStatus
Jersey City Medical Center Jersey City New Jersey
New Mexico Orthopaedics Albuquerque New Mexico
University of North Carolina Chapel Hill North Carolina
Oregon Health and Science University Portland Oregon
Tidewater Orthopaedics Hampton Virginia
Ortho Virginia Richmond Virginia

More Zimmer Biomet trials in Mexico

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03308929 on ClinicalTrials.gov ↗ ← All trials in Mexico