Back to resultsG7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
Primary Purpose
Total Hip Arthroplasty, Degenerative Joint Disease of Hip, Avascular Necrosis of Hip
Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Vivacit-E and Longevity (HXLPE) Liners
Sponsored by
About this trial
This is an interventional treatment trial for Total Hip Arthroplasty
Eligibility Criteria
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.
Sites / Locations
- Colorado Joint ReplacementRecruiting
- South Bend Orthopaedics
- Duke University Medical Center
- Slocum Center for Orthopedics & Sports Medicine
- Oregon Health and Science UniversityRecruiting
- University of Utah HealthRecruiting
- Copenhagen University Hospital HvidovreRecruiting
- Zuyderland Hospital
- OCON HengeloRecruiting
- Skane University HospitalRecruiting
- The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene Liners
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04754087
Brief Title
G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
December 31, 2033 (Anticipated)
Study Completion Date
December 31, 2033 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene Liners
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vivacit-E and Longevity (HXLPE) Liners
Intervention Description
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.
Primary Outcome Measure Information:
Title
Survival of the study device (liner); whether or not it is still implanted in the subject
Description
Survivorship will be based on revision or intended revision of the study device (liner).
Time Frame
At 10 years
Title
Adverse Event (safety)
Description
Safety will be evaluated by monitoring the frequency and incidence of device related adverse events or unanticipated adverse device effects in investigational subjects.
Time Frame
At 10 years
Secondary Outcome Measure Information:
Title
Pain and Function using Modified Harris Hip Score
Description
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.
Time Frame
At 10 years
Title
Pain and Function using Oxford Hip Score
Description
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.
Time Frame
At 10 years
Title
Patient Quality of Life using EQ-5D-5L Descriptive System
Description
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.
Time Frame
At 10 years
Title
Patient Quality of Life using EQ-5D-5L EQ visual analogue scale
Description
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.
Time Frame
At 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy J Hatcher, BS
Phone
574-549-4281
Email
wendy.hatcher@zimmerbiomet.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Boylan, MBA
Phone
574 527 7934
Email
Ryan.Boylan@zimmerbiomet.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillary Overholser
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Colorado Joint Replacement
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheryl Giambartolomei, RN
Phone
303-765-3536
Email
sherylgiambartolomei@centura.org
First Name & Middle Initial & Last Name & Degree
Todd M Miner, MD
Facility Name
South Bend Orthopaedics
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46635
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Slocum Center for Orthopedics & Sports Medicine
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Smith
Phone
503-494-2963
Email
smithreb@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Kathryn Schabel, MD
Facility Name
University of Utah Health
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brenna Blackburn, PhD MPH
Phone
859-533-5996
Email
Brenna.Blackburn@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Jeremy M Gililland
First Name & Middle Initial & Last Name & Degree
Christopher L Peters
First Name & Middle Initial & Last Name & Degree
Christopher E Pelt, MD
First Name & Middle Initial & Last Name & Degree
Michael J Archibeck, MD
Facility Name
Copenhagen University Hospital Hvidovre
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anders Troelsen, MD, PhD
Phone
+45 27 337008
Email
Anders.Troelsen@regionh.dk
First Name & Middle Initial & Last Name & Degree
Anders Troelsen, MD, PhD
Facility Name
Zuyderland Hospital
City
Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Individual Site Status
Active, not recruiting
Facility Name
OCON Hengelo
City
Hengelo
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dean Pakvis, MD
Phone
+46 70 4604525
Email
d.pakvis@ocon.nl
First Name & Middle Initial & Last Name & Degree
Dean Pakvis, MD
Facility Name
Skane University Hospital
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uldis Kesteris, MD
Phone
+46 70 4604525
Email
uldis.kesteris@med.lu.se
First Name & Middle Initial & Last Name & Degree
Uldis Kesteris, MD
Facility Name
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital
City
Bournemouth
State/Province
UK
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Middelton, MD, PhD
Phone
+44 01202 303477
Email
robert.middleton@rbch.nhs.uk
First Name & Middle Initial & Last Name & Degree
Robert Middleton, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
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