Actively Recruiting
Global, Multicenter, and Prospective Study of the G7 Acetabular System With Vivacit-E and Longevity Highly Crosslinked Polyethylene Liners in Total Hip Arthroplasty
Led by Zimmer Biomet · Updated on 2025-06-18
300
Participants Needed
11
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells used with Vivacit-E and Longevity highly crosslinked polyethylene (HXLPE) liners in patients undergoing primary or revision total hip arthroplasty. This study aims to confirm how well the implant system lasts over 10 years and to monitor any adverse events related to the implant or instrumentation. The research also assesses patient-reported outcomes and radiographic results to understand clinical benefits. Up to 300 hips will be implanted globally with a G7 Shell combined with either the Vivacit-E or Longevity liner. The liners are divided into two groups, with 150 subjects receiving Vivacit-E liners and 150 receiving Longevity liners. Each participating site will use one type of liner identified at the start of the study. The study involves a prospective, multicenter design to follow patients over time. Participants will be monitored for 10 years to evaluate device survival, defined as whether the implant remains in place or is removed. Safety is assessed by recording any adverse events and their relationship to the implant or instrumentation. Clinical performance and benefits are measured through patient-reported outcomes like pain and function using the Modified Harris Hip Score and Oxford Hip Score, as well as quality of life using the EQ-5D-5L system. Follow-up visits will include these assessments to track progress and implant success.
CONDITIONS
Brief Title
G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, or revision procedures where other treatments or devices have failed.
- Patient must be able and willing to complete the required follow-up visits.
- Patient must be able and willing to sign the approved informed consent.
You will not qualify if you...
- Patient has osteoporosis that may limit the ability to support total hip arthroplasty with the study device.
- Patient has a metabolic disorder that may impair bone formation.
- Patient has osteomalacia.
- Patient has distant infections that may spread to the implant site or has infection, sepsis, or osteomyelitis.
- Patient has rapid joint destruction, marked bone loss, or bone resorption visible on X-rays.
- Patient has vascular insufficiency, muscular atrophy, or neuromuscular disease.
- Patient is a prisoner.
- Patient is a current alcohol or drug abuser.
- Patient is uncooperative or has neurologic disorders preventing following directions.
- Patient is pregnant.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants will receive the G7 Shell with either the Vivacit-E or Longevity Highly Crosslinked Polyethylene liner implanted during total hip arthroplasty.
1 surgery visit (in-person)
Duration - Up to 10 years
Participants will be monitored for safety and performance of the implant through clinical and radiographic assessments, including patient-reported outcomes on pain, function, and quality of life.
Regular follow-up visits over 10 years
Trial Site Locations
Total: 11 locations
1
Colorado Joint Replacement
Denver, Colorado, United States, 80210
Active, Not Recruiting
2
South Bend Orthopaedics
South Bend, Indiana, United States, 46635
Active, Not Recruiting
3
Duke University Medical Center
Durham, North Carolina, United States, 27703
Active, Not Recruiting
4
Slocum Center for Orthopedics & Sports Medicine
Eugene, Oregon, United States, 97401
Active, Not Recruiting
5
Oregon Health and Science University
Portland, Oregon, United States, 97239
Active, Not Recruiting
6
University of Utah Health
Salt Lake City, Utah, United States, 84112
Active, Not Recruiting
7
Copenhagen University Hospital Hvidovre
Hvidovre, Denmark, 2650
Actively Recruiting
8
Zuyderland Hospital
Geleen, Netherlands, 6162 BG
Active, Not Recruiting
9
OCON Hengelo
Hengelo, Netherlands
Actively Recruiting
10
Skane University Hospital
Lund, Sweden, 221 85
Actively Recruiting
11
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust Royal Bournemouth Hospital
Bournemouth, UK, United Kingdom, BH7 7DW
Actively Recruiting
Research Team
W
Wendy J Hatcher
L
Lynsey Boyle
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here