300 Participants Needed

Hip Replacement Liners for Osteoarthritis

Recruiting at 9 trial locations
WJ
RB
WJ
LB
JD
MP
Overseen ByMichael P Bolognesi, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Zimmer Biomet
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the G7 Acetabular System and similar hip replacement liners safe for humans?

The G7 Acetabular System and similar hip replacement liners, like dual mobility systems, have shown potential advantages in reducing dislocation rates, but there are concerns about complications such as intraprosthetic dislocation and metal ion release. These issues suggest that while they can be beneficial, they should be used carefully, especially in younger patients.12345

What makes the G7 Acetabular System treatment unique for hip replacement in osteoarthritis?

The G7 Acetabular System is unique because it uses a dual mobility design, which allows for greater stability and a wider range of motion in hip replacements, reducing the risk of dislocation compared to traditional systems.16789

What data supports the effectiveness of the G7 Acetabular System and related components for hip replacement in osteoarthritis?

Research on dual mobility systems, which are part of the G7 Acetabular System, shows they can provide greater stability and a wide range of motion, which are beneficial for hip replacements. However, there are concerns about wear and dislocation rates, with some studies indicating that these systems may not significantly reduce wear compared to conventional systems.1791011

Who Is on the Research Team?

HO

Hillary Overholser

Principal Investigator

Zimmer Biomet

Are You a Good Fit for This Trial?

This trial is for adults with full skeletal maturity who need hip replacement due to conditions like osteoarthritis or fractures. Candidates must be able to follow the study protocol and attend follow-up visits. Pregnant individuals, those with bone formation disorders, severe osteoporosis, infections that could affect the implant site, substance abuse issues, or unmanageable neuromuscular diseases cannot participate.

Inclusion Criteria

I am being treated for a joint condition, arthritis, a functional deformity, or certain types of fractures.
Patient must be able and willing to sign the Institutional Review Board or Ethics Committee (IRB/EC) approved informed consent.
Patient must be able and willing to complete the protocol required follow-up visits.
See 1 more

Exclusion Criteria

Patient is a prisoner.
You are currently pregnant.
I have a condition affecting my blood vessels, muscles, or nerves.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implantation of the G7 Acetabular Shells with Vivacit-E or Longevity HXLPE liners in primary and revision total hip arthroplasty

Surgical procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of implant survival and adverse events

10 years
Annual visits for assessment

Long-term follow-up

Continued monitoring of patient-reported outcomes and quality of life measures

10 years

What Are the Treatments Tested in This Trial?

Interventions

  • G7 Acetabular System
  • Vivacit-E and Longevity (HXLPE) Liners
Trial Overview The study aims to confirm safety and effectiveness of G7 Acetabular Shells used with Vivacit-E and Longevity HXLPE liners in primary and revision total hip replacements. It's designed to track long-term outcomes in patients receiving these specific hip implant components.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene LinersExperimental Treatment1 Intervention

G7 Acetabular System is already approved in European Union, United States for the following indications:

🇪🇺
Approved in European Union as G7 Acetabular System for:
🇺🇸
Approved in United States as G7 Acetabular System for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials
383
Recruited
67,800+
Dr. Nitin Goyal profile image

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

Ivan Tornos profile image

Ivan Tornos

Zimmer Biomet

Chief Executive Officer since 2023

MBA from the University of Miami School of Business, BBA in Finance and International Marketing and Management from the University of Georgia Terry College of Business

Published Research Related to This Trial

In a study of 6 patients with Anatomical Dual Mobility hip implants, dynamic radiostereometry confirmed that the polyethylene liner moves over time, with significant movements detected during hip motion, particularly in the smaller articulation between the head and liner.
At the 1-year follow-up, the median movements of the liner included anteversion of 10°, inclination of 6°, and rotation of 11°, indicating that the liner's motion is a critical factor in understanding the mechanics of dual-mobility hip arthroplasty.
Polyethylene liner motion in dual-mobility hip prostheses: static and dynamic radiostereometry in 16 patients 1 year after operation.Jørgensen, PB., Kaptein, BL., Søballe, K., et al.[2023]
Cemented dual mobility liners showed excellent aseptic revision-free survivorship rates of 93.3% for previous acetabular cups, 92.3% for new cups, and 100% for native acetabula over a mean follow-up of 4 years, indicating their effectiveness in various surgical scenarios.
Patients reported significant improvements in hip function and quality of life post-surgery, with low complication rates, including only 3 prosthetic joint infections and no evidence of acetabular subsidence, highlighting the safety and efficacy of this intervention.
Cementation of a Metal Dual Mobility Liner in Patients Undergoing Revision Total Hip Arthroplasty.Chen, Z., Bains, SS., Dubin, JA., et al.[2023]
The study analyzed 66 explanted liners from dual mobility total hip arthroplasties, revealing that longer implantation times correlated with more homogeneous wear patterns on the convex side of the liners.
Heat color treatment effectively highlighted wear patterns, indicating that optimal convexity mobility may reduce contact stresses and improve the longevity of the implant, while intra-prosthetic dislocations primarily caused internal circular wear without damaging the liner.
Understanding wear in dual mobility total hip replacement: first generation explant wear patterns.Boyer, B., Neri, T., Geringer, J., et al.[2019]

Citations

Polyethylene liner motion in dual-mobility hip prostheses: static and dynamic radiostereometry in 16 patients 1 year after operation. [2023]
Cementation of a Metal Dual Mobility Liner in Patients Undergoing Revision Total Hip Arthroplasty. [2023]
Understanding wear in dual mobility total hip replacement: first generation explant wear patterns. [2019]
Dual poly liner mobility optimizes wear and stability in THA: opposes. [2018]
Dual mobility retentive acetabular liners and wear: surface analysis of 40 retrieved polyethylene implants. [2014]
Dual mobility cups provide biomechanical advantages in situations at risk for dislocation: a finite element analysis. [2019]
Early intraprosthetic dislocation in dual-mobility implants: a systematic review. [2022]
Metal Ion Levels in Young, Active Patients Receiving a Modular, Dual Mobility Total Hip Arthroplasty. [2018]
Biomechanical concept and clinical outcome of dual mobility cups. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Polyethylene Dual Mobility Liners Show Minimal Polyethylene Changes in Early Retrievals. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Component dissociation after closed reduction of dual mobility sockets - a report of three cases. [2017]
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