Dual-Mobility vs Conventional Hip Implants for Hip Replacement

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two types of hip implants used in hip replacement surgeries: conventional implants and modular dual-mobility implants. The researchers aim to determine if dual-mobility implants increase metal levels in the blood, potentially affecting health. Participants will be divided into two groups, each receiving one type of implant. Ideal candidates are individuals with osteoarthritis who need hip replacement and are willing to have their blood tested after surgery. As a Phase 4 trial, this research involves FDA-approved treatments and helps to understand their benefits for more patients, offering participants a chance to contribute to improved healthcare outcomes.

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 is the safety track record for these treatments?

Research has shown that dual mobility hip implants are generally safe for patients. Studies indicate a low risk of problems, such as dislocation or the need for additional surgery. For instance, one study found that dual mobility implants performed well over two years, with few issues of instability. Another study found no difference in local complication rates compared to regular hip replacements, indicating similar short-term safety for both types.

Conventional hip implants also have a strong safety record. They have been used for many years and are considered a standard treatment. Research suggests that both dual mobility and conventional hip implants are well-tolerated and have comparable safety levels.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about dual-mobility hip implants because they offer a unique design compared to conventional hip implants. Traditional hip replacements typically use a single ball-and-socket joint, which can sometimes lead to dislocations or reduced range of motion. The dual-mobility design incorporates an additional polyethylene bearing that allows for greater movement and stability, potentially reducing the risk of dislocation. This innovation could improve outcomes for patients by providing more natural movement and enhancing the longevity of the implant, making it an attractive option for active individuals or those at higher risk of dislocation.

What evidence suggests that this trial's treatments could be effective for hip replacement?

This trial will compare dual mobility hip implants with conventional hip implants. Research has shown that dual mobility hip implants perform very well. Studies indicate they have a lower risk of dislocation compared to regular implants. For instance, one study found that these implants had a low risk of instability or dislocation after two years. Another study showed they performed better in revision surgeries. Overall, dual mobility implants are effective and reliable for hip replacements.12567

Are You a Good Fit for This Trial?

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.
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Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Modular Dual Mobility CohortExperimental Treatment1 Intervention
Group II: Conventional CohortActive Control1 Intervention

Find a Clinic Near You

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 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

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.
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]
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

Comparison of Outcomes Between Modular Dual Mobility ...The results suggest similar overall outcomes and a lower dislocation rate for patients who received an MDM hip. Introduction. Total hip ...
Two-Year Outcomes of Novel Dual-Mobility Implant in ...This novel DM acetabular implant demonstrates excellent survivorship at two years follow-up with low rates of instability and intraprosthetic dislocation.
The Performance of Primary Dual-Mobility Total Hip ...The literature demonstrates satisfactory short-term outcomes with a mitigated risk of dislocation for DM used as primary THA in patients aged 55 years and ...
Modular dual-mobility constructs outperformed large femoral ...Modular dual-mobility constructs outperformed large femoral heads in 299 revision total hip arthroplasties at mid-term follow-up.
Outcomes of dual mobility versus conventional total hip ...This study compared the long-term efficacy and safety of dual mobility (DM) prostheses versus conventional total hip arthroplasty (c-THA) in femoral neck ...
Comparison of Short-Term Outcomes and Survivorship ...Outcomes included acetabular revision, 90-day readmission, and Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR). Kaplan–Meier ...
Dual-Mobility Acetabular Components in Primary Total Hip ...This matched study shows that there is no difference in local complication rates between DM and conventional THA articulations.
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