Hip Replacement Liners for Osteoarthritis

Recruiting at 9 trial locations

Overseen By Jeffrey D Yergler, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zimmer Biomet

Disqualifiers: Osteoporosis, Metabolic disorder, Osteomalacia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure

300 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{1 3 5 10 11}

Research Team

Hillary Overholser

Principal Investigator

Zimmer Biomet

Eligibility Criteria

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.

Exclusion Criteria

Patient is a prisoner.

You are currently pregnant.

I have a condition affecting my blood vessels, muscles, or nerves.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: G7 Shell with Vivacit-E and Longevity Highly Crosslinked Polyethylene Liners Experimental Treatment 1 Intervention

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.

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

Approved in European Union as G7 Acetabular System for:

• Non-inflammatory degenerative joint disease
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement
• Revision procedures where other treatment or devices have failed

Approved in United States as G7 Acetabular System for:

• Non-inflammatory degenerative joint disease
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement
• Revision procedures where other treatment or devices have failed

Who Is Running the Clinical Trial?

Zimmer Biomet

Lead Sponsor

Trials

383

Recruited

67,800+

Dr. Nitin Goyal

Zimmer Biomet

Chief Medical Officer since 2021

MD from Harvard Medical School

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

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding wear in dual mobility total hip replacement: first generation explant wear patterns. Boyer, B., Neri, T., Geringer, J., et al.[2019]

The dual-mobility acetabular component in total hip arthroplasty (THA) aims to improve stability and range of motion, but it has not significantly reduced the incidence of dislocation compared to conventional THA, with a 0.4% instability rate reported.

However, the dual-mobility design introduces a higher risk of intraprosthetic dislocation (3.6%) and does not effectively prevent wear or osteolysis, raising concerns about its long-term efficacy and suitability for revision surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual poly liner mobility optimizes wear and stability in THA: opposes. Lyons, MC., MacDonald, SJ.[2018]

In a study of 40 retrieved polyethylene liners from total hip arthroplasties, dual mobility systems showed wear rates similar to conventional metal-polyethylene bearings, with a mean total wear of 82 μm over an average of 8 years.

The dual mobility system provides enhanced joint stability without increasing wear, making it a favorable option for hip replacements compared to traditional bearing systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual mobility retentive acetabular liners and wear: surface analysis of 40 retrieved polyethylene implants. Adam, P., Farizon, F., Fessy, MH.[2014]

Dual mobility implants showed superior biomechanical performance, providing the greatest range of motion to impingement and delaying dislocation compared to standard and constrained implants.

The study suggests that dual mobility systems are safer and more effective for patients at risk of instability after total hip arthroplasty, while constrained implants should only be used in salvage situations due to their higher rates of mechanical failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual mobility cups provide biomechanical advantages in situations at risk for dislocation: a finite element analysis. Terrier, A., Latypova, A., Guillemin, M., et al.[2019]

A systematic review of 16 articles identified that early intraprosthetic dislocation (IPD) in dual mobility implants is often linked to attempted closed reduction, suggesting a potential iatrogenic cause for these complications.

Out of 19 total hip arthroplasties studied, 15 patients experienced early IPD after a mean follow-up of just 3.2 months, highlighting the need for careful management and recognition of this complication to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early intraprosthetic dislocation in dual-mobility implants: a systematic review. De Martino, I., D'Apolito, R., Waddell, BS., et al.[2022]

In a study of 26 young, active patients receiving dual mobility total hip arthroplasty (THA), blood cobalt levels were significantly higher one year post-surgery compared to a control group, indicating potential metal ion release from the modular cobalt alloy components.

Four patients in the dual mobility group had cobalt levels exceeding the normal reference range, highlighting the need for ongoing monitoring of metal ion levels in patients with this type of prosthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metal Ion Levels in Young, Active Patients Receiving a Modular, Dual Mobility Total Hip Arthroplasty. Nam, D., Salih, R., Brown, KM., et al.[2018]

Dual mobility cup systems in total hip arthroplasty show reduced dislocation rates compared to standard hip replacements, suggesting improved stability for patients undergoing both primary and revision surgeries.

However, concerns about long-term implant survival, increased wear rates, and aseptic loosening mean that these implants should be used cautiously, especially in younger patients and standard primary hip arthroplasties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomechanical concept and clinical outcome of dual mobility cups. Grazioli, A., Ek, ET., Rüdiger, HA.[2022]

In a study of 37 dual mobility liners implanted for an average of 35 months, the inner bearing showed a higher oxidation index compared to the outer bearing, indicating some material changes over time.

Despite these small differences in oxidation, the overall levels were low and unlikely to affect the mechanical properties of the polyethylene material, suggesting that dual mobility liners remain a safe option for reducing instability in total hip arthroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Polyethylene Dual Mobility Liners Show Minimal Polyethylene Changes in Early Retrievals. Zlotnicki, JP., Baral, EC., Westrich, GH., et al.[2023]

The use of dual mobility sockets in hip arthroplasty is on the rise, particularly in revision surgeries, to address potential instability issues.

This report highlights three cases of intra-prosthetic dissociation occurring between the outer polyethylene liner and the femoral head following closed reduction of dislocated prostheses, indicating a possible complication associated with dual mobility designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Component dissociation after closed reduction of dual mobility sockets - a report of three cases. Stigbrand, H., Ullmark, G.[2017]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Polyethylene liner motion in dual-mobility hip prostheses: static and dynamic radiostereometry in 16 patients 1 year after operation. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Cementation of a Metal Dual Mobility Liner in Patients Undergoing Revision Total Hip Arthroplasty. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Understanding wear in dual mobility total hip replacement: first generation explant wear patterns. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Dual poly liner mobility optimizes wear and stability in THA: opposes. [2018]

5. France pubmed.ncbi.nlm.nih.gov

Dual mobility retentive acetabular liners and wear: surface analysis of 40 retrieved polyethylene implants. [2014]

6. Germany pubmed.ncbi.nlm.nih.gov

Dual mobility cups provide biomechanical advantages in situations at risk for dislocation: a finite element analysis. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Early intraprosthetic dislocation in dual-mobility implants: a systematic review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Metal Ion Levels in Young, Active Patients Receiving a Modular, Dual Mobility Total Hip Arthroplasty. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

Biomechanical concept and clinical outcome of dual mobility cups. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Polyethylene Dual Mobility Liners Show Minimal Polyethylene Changes in Early Retrievals. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Component dissociation after closed reduction of dual mobility sockets - a report of three cases. [2017]