G7 Freedom Constrained Vivacit-E Liners

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Zimmer Biomet
Study ID
NCT05587244
Status
Enrolling By Invitation

Conditions

  • Avascular Necrosis
  • Dislocation, Hip
  • Femoral Neck Fractures
  • Non-Union Fracture
  • Osteoarthritis, Hip
  • Rheumatoid Arthritis
  • Trochanteric Fractures

Eligibility Criteria

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

Interventions

  • Total Hip Arthroplasty with G7 Freedom Constrained Vivacit-E Liners — DEVICE
    Primary and/or Revision total hip arthroplasty with the G7 Freedom Constrained Vivacit-E Liners

Study Details

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Freedom Constrained Vivacit-E Acetabular Liners in primary and revision total hip arthroplasty.

Key Dates

Start date
May 8, 2023
Status verified
Oct 2025
Primary completion
Dec 31, 2037
Completion
Dec 31, 2038

Study Design

Enrollment
202 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Total Hip Arthroplasty Treatment Group
    This study will enroll (implant) up to 202 hips in total according to the IFU and surgical technique. Of these, up to 135 will be revision hips and up to 67 will be primary hips. This is a dual cohort study (primary and revision); each subject will receive the G7 Acetabular System with the Freedom Constrained Vivacit-E bearing. To minimize potential bias and to maximize our ability to assess inter-site differences, each study site will target up to 27 primary hip arthroplasties and up to 54 revision hip arthroplasties (not exceed 81 implanted hips or 40% of total study population). Each site is encouraged to enroll (implant) both primary and revision subjects.

Primary Outcome Measure

Survival of the study device [ Time Frame: 10 years ]

Locations (10)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35205-
University of Southern CaliforniaLos AngelesCalifornia90033-
University of Florida Board of TrusteesGainesvilleFlorida32611-
Jersey City Medical Center, IncLivingstonNew Jersey07039-
The Ohio State UniversityColumbusOhio43201-
TOA Research FoundationKnoxvilleTennessee37923-
The University of Texas Health Science Center of HoustonHoustonTexas77030-
Medical City PlanoPlanoTexas75075-
University of UtahSalt Lake CityUtah84108-
West Virginia UniversityMorgantownWest Virginia26506-

Find similar trials in Birmingham, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
University of Alabama at Birmingham· Birmingham, ALUniversity of Southern California· Los Angeles, CAUniversity of Florida Board of Trustees· Gainesville, FLJersey City Medical Center, Inc· Livingston, NJThe Ohio State University· Columbus, OHTOA Research Foundation· Knoxville, TN

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