Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT04754087

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

Led by Zimmer Biomet · Updated on 2025-06-18

300

Participants Needed

11

Research Sites

651 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient must be a legal adult who has reached full skeletal maturity.
  • Patient must be treated for one of the following: 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 treatments or devices have failed.
  • Patient must be able and willing to complete the required follow-up visits.
  • Patient must be able and willing to sign the IRB/EC approved informed consent.
Not Eligible

You will not qualify if you...

  • Patient has osteoporosis that may limit the ability to support total hip arthroplasty with the study device.
  • Patient has a metabolic disorder impairing bone formation.
  • Patient has osteomalacia.
  • Patient has distant infections that may spread to the implant site or active infection, sepsis, or osteomyelitis.
  • Patient has rapid joint destruction, marked bone loss, or bone resorption visible on X-rays.
  • Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease.
  • Patient is a prisoner.
  • Patient is a current alcohol or drug abuser.
  • Patient is uncooperative or has neurologic disorders preventing following directions.
  • Patient is pregnant.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

Colorado Joint Replacement

Denver, Colorado, United States, 80210

Active, Not Recruiting

2

South Bend Orthopaedics

South Bend, Indiana, United States, 46635

Active, Not Recruiting

3

Duke University Medical Center

Durham, North Carolina, United States, 27703

Active, Not Recruiting

4

Slocum Center for Orthopedics & Sports Medicine

Eugene, Oregon, United States, 97401

Active, Not Recruiting

5

Oregon Health and Science University

Portland, Oregon, United States, 97239

Active, Not Recruiting

6

University of Utah Health

Salt Lake City, Utah, United States, 84112

Active, Not Recruiting

7

Copenhagen University Hospital Hvidovre

Hvidovre, Denmark, 2650

Actively Recruiting

8

Zuyderland Hospital

Geleen, Netherlands, 6162 BG

Active, Not Recruiting

9

OCON Hengelo

Hengelo, Netherlands

Actively Recruiting

10

Skane University Hospital

Lund, Sweden, 221 85

Actively Recruiting

11

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital

Bournemouth, UK, United Kingdom, BH7 7DW

Actively Recruiting

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Research Team

W

Wendy J Hatcher

CONTACT

L

Lynsey Boyle

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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