RECRUITING

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

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

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-07-07

Study Completion:2033-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04754087

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Wendy J Hatcher

CONTACT

574-549-4281

wendy.hatcher@zimmerbiomet.com

Lynsey Boyle

CONTACT

412-552-7111

lynsey.boyle@zimmerbiomet.com

Principal Investigator

Hillary Overholser

STUDY_DIRECTOR

Zimmer Biomet

Study Locations (Sites)

Colorado Joint Replacement

Denver, Colorado, 80210

United States

South Bend Orthopaedics

South Bend, Indiana, 46635

United States

Duke University Medical Center

Durham, North Carolina, 27703

United States

Slocum Center for Orthopedics & Sports Medicine

Eugene, Oregon, 97401

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

University of Utah Health

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: Zimmer Biomet

Hillary Overholser, STUDY_DIRECTOR, Zimmer Biomet

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-07

Study Completion Date2033-12-31

Study Record Updates

Study Start Date2021-07-07

Study Completion Date2033-12-31

Terms related to this study

Additional Relevant MeSH Terms

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