G7 Dual Mobility With Vivacit-E or Longevity PMCF

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Zimmer Biomet
Study ID
NCT05548972
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • G7 Dual Mobility with Vivacit-E bearing — DEVICE
    hip arthroplasty with G7 Dual Mobility Vivacit-E bearing
  • G7 Dual Mobility Longevity bearing — DEVICE
    hip arthroplasty with G7 Dual Mobility Longevity bearing

Study Details

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

Key Dates

Start date
Mar 20, 2023
Status verified
Jun 2025
Primary completion
Jan 31, 2037
Completion
Aug 31, 2037

Study Design

Enrollment
358 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: G7 Dual Mobility with Vivacit-E polyethylene bearing in primary THA
    Subjects in need of a total hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 60)
  • Other: G7 Dual Mobility with Vivacit-E polyethylene bearing in revision (total) hip arthroplasty
    Subjects in need of a revision (total) hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 119)
  • Other: G7 Dual Mobility with Longevity polyethylene bearing in primary THA
    Subjects in need of a total hip arthroplasty who meet inclusion/exclusion criteria(anticipated enrollment: 60)
  • Other: G7 Dual Mobility with Vivacit-E Longevity bearing in revision (total) hip arthroplasty
    Subjects in need of a revision (total) hip arthroplasty who meet inclusion/exclusion criteria (anticipated enrollment: 119)

Primary Outcome Measure

Survival of the implant system [ Time Frame: 10 years ]

Locations (6)

FacilityCityStateZIPSite coordinators
Bowen Hefley OrthopedicsLittle RockArkansas72205-
HCA HealthONE Orthopedic SpecialistsDenverColorado80218-
Jersey City Medical CenterJersey CityNew Jersey07302-
Hospital for Special SurgeryNew YorkNew York10021-
The Cleveland ClinicClevelandOhio44195-
Slocum Research & Education FoundationEugeneOregon97401-

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By research site
Bowen Hefley Orthopedics· Little Rock, ARHCA HealthONE Orthopedic Specialists· Denver, COJersey City Medical Center· Jersey City, NJHospital for Special Surgery· New York, NYThe Cleveland Clinic· Cleveland, OHSlocum Research & Education Foundation· Eugene, OR

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