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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Hip; Avascular Necrosis of Hip; Total Hip Arthroplasty; Osteoarthritis of Hip; Fracture of Hip; Degenerative Joint Disease of Hip; Fractures, Hip; Rheumatoid Arthritis of Hip
• Intervention / Treatment: Device: Vivacit-E and Longevity (HXLPE) Liners

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lynsey Boyle; Phone Number: 412-552-7111; Email: lynsey.boyle@zimmerbiomet.com
• Study Contact Backup: Name: Wendy J Hatcher; Phone Number: 574-549-4281; Email: wendy.hatcher@zimmerbiomet.com

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Recruiting
    • Copenhagen University Hospital Hvidovre
    • Contact: Anders Troelsen, MD, PhD; Phone Number: +45 27 337008; Email: Anders.Troelsen@regionh.dk
    • Principal Investigator: Anders Troelsen, MD, PhD
• Netherlands
  • Geleen, Netherlands, 6162 BG
    • Active, not recruiting
    • Zuyderland hospital
  • Hengelo, Netherlands
    • Recruiting
    • OCON Hengelo
    • Contact: Dean Pakvis, MD; Phone Number: +46 70 4604525; Email: d.pakvis@ocon.nl
    • Principal Investigator: Dean Pakvis, MD
• Sweden
  • Lund, Sweden, 221 85
    • Recruiting
    • Skane University Hospital
    • Contact: Uldis Kesteris, MD; Phone Number: +46 70 4604525; Email: uldis.kesteris@med.lu.se
    • Principal Investigator: Uldis Kesteris, MD
• United Kingdom
  • UK
    • Bournemouth, UK, United Kingdom, BH7 7DW
      • Recruiting
      • The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital
      • Contact: Robert Middelton, MD, PhD; Phone Number: +44 01202 303477; Email: robert.middleton@rbch.nhs.uk
      • Principal Investigator: Robert Middleton, MD, PhD
• United States
  • Colorado
    • Denver, Colorado, United States, 80210
      • Active, not recruiting
      • Colorado Joint Replacement
  • Indiana
    • South Bend, Indiana, United States, 46635
      • Active, not recruiting
      • South Bend Orthopaedics
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Active, not recruiting
      • Duke University Medical Center
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Active, not recruiting
      • Slocum Center for Orthopedics & Sports Medicine
    • Portland, Oregon, United States, 97239
      • Active, not recruiting
      • Oregon Health and Science University
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah Health
      • Sub-Investigator: Christopher E Pelt, MD
      • Sub-Investigator: Michael J Archibeck, MD
      • Contact: Claire Kapron; Phone Number: 801-587-5230; Email: u1096331@utah.edu
      • Principal Investigator: Jeremy M Gililland, MD
      • Sub-Investigator: Christopher L Peters, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of the study device (liner); whether or not it is still implanted in the subject	Survivorship will be based on revision or intended revision of the study device (liner).	At 10 years
Adverse Event (safety)	Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.	At 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and Function using Modified Harris Hip Score	Pain and function will be measured using the Modified Harris Hip Score self assessment. The overall score runs from 0-100 with 100 representing the best outcome.	At 10 years
Pain and Function using Oxford Hip Score	Pain and function will be measured using the Oxford Hip Score self assessment. The overall score runs from 0-48 with 48 representing the best outcome.	At 10 years
Patient Quality of Life using EQ-5D-5L Descriptive System	Perceived qualify of life will be measured using the EQ-5D-5L Descriptive System - comprises mobility, self care, usual activities, pain/discomfort, anxiety/depression. Each question in this section has an overall score of 1-5 with 1 representing the best health.	At 10 years
Patient Quality of Life using EQ-5D-5L EQ visual analogue scale	Perceived qualify of life will be measured using the EQ visual analogue scale (EQ VAS) - records the respondent's self-rated health on a vertical, visual analogue scale. This section has an overall score of 0-100 with 100 representing the best health.	At 10 years

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hillary Overholser, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2033

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Leg Injuries; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Femoral Fractures; Hip Injuries; Osteoarthritis; Joint Diseases; Necrosis; Fractures, Bone; Hip Fractures; Osteoarthritis, Hip
• Other Study ID Numbers: CMG2019-32H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes