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

Part of paid clinical trials in Denver, Colorado.

Sponsor
Zimmer Biomet
Study ID
NCT04754087
Status
Recruiting
Apply to this trial

Conditions

  • Avascular Necrosis of Hip
  • Degenerative Joint Disease of Hip
  • Fracture of Hip
  • Fractures, Hip
  • Osteoarthritis of Hip
  • Osteoarthritis, Hip
  • Rheumatoid Arthritis of Hip
  • Total Hip Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Vivacit-E and Longevity (HXLPE) Liners — DEVICE
    This is a dual cohort study in which 150 subjects will receive the Vivacit-E (HXLPE) Liner and 150 subjects will receive the Longevity (HXLPE) Liner.

Study Details

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and revision total hip arthroplasty.

Key Dates

Start date
Jul 7, 2021
Status verified
Jun 2025
Primary completion
Dec 31, 2033
Completion
Dec 31, 2033

Study Design

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

Arms

  • Other: G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene Liners
    Up to 300 hips globally will be implanted with a G7 Shell and either the Vivacit-E or Longevity Liner. The liner used by each site will be identified at start-up.

Primary Outcome Measure

Survival of the study device (liner); whether or not it is still implanted in the subject [ Time Frame: At 10 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Colorado Joint ReplacementDenverColorado80210-
South Bend OrthopaedicsSouth BendIndiana46635-
Duke University Medical CenterDurhamNorth Carolina27703-
Slocum Center for Orthopedics & Sports MedicineEugeneOregon97401-
Oregon Health and Science UniversityPortlandOregon97239-
University of Utah HealthSalt Lake CityUtah84112-

Find similar trials in Denver, CO

By research site
Colorado Joint Replacement· Denver, COSouth Bend Orthopaedics· South Bend, INDuke University Medical Center· Durham, NCSlocum Center for Orthopedics & Sports Medicine· Eugene, OROregon Health and Science University· Portland, ORUniversity of Utah Health· Salt Lake City, UT

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