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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-07

Study Completion Date

2033-12-31

Brief Summary

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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.

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Detailed Description

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The primary endpoint is defined by the survival of the implant system at 10 years, which is based on removal or intended removal of the study device and will be determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to either implant or instrumentation should be specified.

The secondary endpoints are the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs) as well as radiographic outcomes (if available).

Conditions

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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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Vivacit-E and Longevity (HXLPE) Liners

Intervention Type 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.

Interventions

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Vivacit-E and Longevity (HXLPE) Liners

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hillary Overholser

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

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