Dual-Mobility vs Conventional Hip Implants for Hip Replacement

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rush University Medical Center

Must not be taking: Chromium supplements

Disqualifiers: Chronic disease, Renal dysfunction, Metal implants, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Surgical procedure

52 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this study is to determine if the use of a modular dual mobility bearing is associated with clinically important increases in serum metal levels.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it does exclude patients taking chromium supplements. It's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of this treatment?

Research shows that dual mobility hip implants can reduce the risk of dislocation after hip replacement surgery, as seen in a study where no dislocations occurred in patients with this type of implant. Additionally, patients experienced improved hip function, with their Harris Hip Scores increasing significantly. ^{1 2 3 4 5}

Is the dual-mobility hip implant generally safe for humans?

Dual-mobility hip implants are designed to improve stability and reduce dislocation risks, but some studies have noted complications like aseptic loosening (implant coming loose without infection) and mechanical failures. While they show potential advantages, the full range of complications is not yet fully understood. ^{1 2 6 7 8}

How does the dual-mobility hip implant treatment differ from conventional hip implants?

Dual-mobility hip implants are designed to reduce the risk of dislocation after hip replacement surgery by allowing a greater range of motion compared to conventional implants. This is achieved through a unique design that includes an additional bearing surface, which helps stabilize the hip joint. ^{1 2 5 6 8}

Eligibility Criteria

This trial is for adults aged 18-80 with a BMI under 40 who need hip replacement surgery and are willing to have blood tests after the operation. It's not for those with prior hip infections, other metal implants (except dental), non-osteoarthritis diagnoses, poor kidney function, previous hip surgeries with metal devices, chromium supplement use, serious chronic diseases or expecting another joint surgery within a year.

Inclusion Criteria

You have a body mass index (BMI) less than 40.

My surgeon has approved me for the necessary implants.

I am willing to have blood tests after surgery.

Exclusion Criteria

My diagnosis before surgery was not osteoarthritis.

I expect to need another joint replacement within a year.

I have had hip surgery with metal parts or screws.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo primary total hip arthroplasty with either a modular dual mobility or conventional single-bearing component

Surgical procedure

1 visit (in-person)

Follow-up

Participants are monitored for serum metal levels and patient-reported outcomes

up to 5 years

Regular visits (in-person and virtual)

Treatment Details

Interventions

• Conventional cohort
• Dual mobility cohort

Trial Overview The study compares two groups in primary total hip arthroplasty (THA): one receiving dual mobility components designed to reduce dislocation risk and wear; the other getting conventional single bearing surfaces. The focus is on whether the dual mobility increases metal levels in blood.

Participant Groups

Group I: Modular Dual Mobility Cohort Experimental Treatment 1 Intervention

Patients in this group will receive a Taperloc femoral stem, inner ceramic femoral head (28mm), mobile polyethylene bearing, cobalt alloy liner, and G7 acetabular shell.

Group II: Conventional Cohort Active Control 1 Intervention

Patients in this group will receive a Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components \> 52mm), polyethylene bearing, and G7 acetabular shell.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Zimmer Biomet

Industry 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

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]

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]

References

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

Selective Use of Dual-Mobility Did Not Significantly Reduce 90-Day Readmissions or Reoperations After Total Hip Arthroplasty. [2023]

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

Mid-Term Outcomes of Dual Mobility Acetabular Cups for Revision Total Hip Arthroplasty. [2022]

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

Revision Dual Mobility Constructs With Unmatched Acetabular and Femoral Components Do Not Increase Failure Rate. [2023]

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

Lack of early dislocation following total hip arthroplasty with a new dual mobility acetabular design. [2017]

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

Fretting and Corrosion Damage of Retrieved Dual-Mobility Total Hip Arthroplasty Systems. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Five-year polyethylene cup migration and PE wear of the Anatomic Dual Mobility acetabular construct. [2023]