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

Description

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

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

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Study Overview

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Study Details

Study overview

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.

Global, Multicenter, and Prospective Post-Market Clinical Follow-Up Study of the G7 Acetabular System with Vivacit-E and Longevity Highly Crosslinked Polyethylene (HXLPE) Liners & Instrumentation

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

Condition
Total Hip Arthroplasty
Intervention / Treatment

-

Contacts and Locations

Denver

Colorado Joint Replacement, Denver, Colorado, United States, 80210

South Bend

South Bend Orthopaedics, South Bend, Indiana, United States, 46635

Durham

Duke University Medical Center, Durham, North Carolina, United States, 27703

Eugene

Slocum Center for Orthopedics & Sports Medicine, Eugene, Oregon, United States, 97401

Portland

Oregon Health and Science University, Portland, Oregon, United States, 97239

Salt Lake City

University of Utah Health, Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patient must be a legal adult who has reached full skeletal maturity.
  • * Patient must be treated for one of the following indications:
  • * 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 treatment or devices have failed
  • * Patient must be able and willing to complete the protocol required follow-up visits.
  • * Patient must be able and willing to sign the Institutional Review Board or Ethics Committee (IRB/EC) approved informed consent.
  • * Patient presents with osteoporosis, which in the opinion of the Principal Investigator, may limit the subject's ability to support total hip arthroplasty using the study device.
  • * Patient has a metabolic disorder that may impair bone formation.
  • * Patient has osteomalacia.
  • * Patient has distant foci of infections which may spread to the implant site or patient with infection, sepsis or osteomyelitis.
  • * Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.
  • * Patient has a vascular insufficiency, muscular atrophy, or neuromuscular disease
  • * Patient is a prisoner.
  • * Patient is a current alcohol or drug abuser.
  • * Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
  • * Patient is pregnant.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Zimmer Biomet,

Hillary Overholser, STUDY_DIRECTOR, Zimmer Biomet

Study Record Dates

2033-12-31