Dual Mobility Implants for Hip Dislocation

Not currently recruiting at 3 trial locations

Overseen By Anne DeBenedetti, BA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rush University Medical Center

Disqualifiers: Under 18, Recent spinopelvic fusion, 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: Unknown

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of hip implants to determine which works better for individuals at high risk of hip dislocation after surgery. One group will receive a dual mobility implant, which may help prevent dislocation, while the other group will receive a traditional single-bearing hip implant. The trial focuses on individuals needing a hip replacement due to arthritis and who have had prior back surgery, particularly those with conditions like Parkinson’s disease or a history of frequent alcohol use. Participants should meet these criteria to ensure the study accurately assesses the implants' effectiveness. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

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 is the safety track record for these treatments?

Research has shown that dual mobility hip implants are generally safe for individuals undergoing total hip replacement surgery. These implants aim to lower the risk of dislocation. Studies have found that they can indeed reduce the chances of dislocation and the need for additional surgery compared to traditional hip implants. However, they might cause extra bone growth in areas where it's not needed (known as heterotopic ossification) and may not perform as well in the short term for some individuals.

In rare cases, a part of the dual mobility implant can move out of place inside the hip, but this usually occurs after another type of dislocation. Overall, these implants are considered safe for hip replacement surgeries.

Traditional single-bearing hip implants have been used for a long time and are well-tested. They perform reliably but might not reduce dislocation risks as effectively as dual mobility implants.

Both types of implants have their advantages and disadvantages, but evidence suggests that both are generally safe for hip replacements. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard single-bearing hip implants, dual mobility implants are designed with two points of articulation, which can significantly reduce the risk of hip dislocation. This unique design allows for greater range of motion and stability, making it an exciting option for patients prone to dislocation. Researchers are particularly enthusiastic because dual mobility implants might offer enhanced durability and improved outcomes for those undergoing hip replacement surgery, potentially leading to fewer revision surgeries and better overall patient satisfaction.

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

Studies have shown that dual mobility implants, a treatment option in this trial, effectively reduce the risk of hip dislocation in patients undergoing total hip replacement. Research indicates that these implants lower both the chances of dislocation and the need for additional surgeries compared to traditional implants, which are also under study in this trial. By allowing more movement in the hip joint, dual mobility implants increase stability. However, they might lead to more bone growth around the implant, which can be a downside. Overall, dual mobility implants offer a promising option for those at high risk of hip dislocation. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 75, or those with a history of lumbar fusion surgery, neuromuscular disorders, cognitive impairments, substance abuse, hip fractures, or inflammatory arthritis. It's not for people under 18 or those who've had previous hip surgeries other than lumbar fusion at least 6 months ago.

Inclusion Criteria

I had hip replacement for arthritis after having spine fusion surgery over 6 months ago.

I am at high risk for hip dislocation due to one or more specific health issues.

Exclusion Criteria

I had spine and pelvis surgery less than 6 months ago.

I have had spine surgery in my neck or upper back.

I am scheduled for or have had a hip replacement revision.

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 (THA) with either a dual mobility bearing or a conventional single-bearing design

Surgical procedure

Follow-up

Participants are monitored for safety and effectiveness, including radiographic assessments and monitoring for complications

10 years

Routine follow-up visits with radiographs

What Are the Treatments Tested in This Trial?

Interventions

• Dual mobility implant
• Traditional, Single-bearing hip implant

Trial Overview The study compares two types of hip implants in high-risk patients needing total hip replacement: a traditional single-bearing implant and an advanced dual mobility implant. The goal is to see which one better prevents the dislocation of the artificial joint.

How Is the Trial Designed?

Group I: Dual mobility Experimental Treatment 1 Intervention

Patients in this group will receive a dual mobility hip implant

Group II: Single bearing, traditional hip implant Active Control 1 Intervention

Patients in this group will receive a traditional, single-bearing hip implant.

Dual mobility implant is already approved in European Union, United States for the following indications:

Approved in European Union as Dual Mobility Implant for:

• Primary total hip arthroplasty in high-risk patients
• Revision total hip arthroplasty for instability
• Patients with neuromuscular disorders
• Patients with cognitive disorders

Approved in United States as Dual Mobility Implant for:

• Primary total hip arthroplasty in high-risk patients
• Revision total hip arthroplasty for instability
• Patients with severe abductor muscle deficiency due to adverse local tissue reaction (ALTR)

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Keck School of Medicine of USC

Collaborator

Trials

3

Recruited

460+

Rothman Institute Orthopaedics

Collaborator

Trials

127

Recruited

22,600+

Keck School of Medicine of USC

Collaborator

Trials

7

Recruited

1,000+

New York University

Collaborator

Trials

249

Recruited

229,000+

Published Research Related to This Trial

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]

Dual mobility cups (DMCs) significantly reduce the dislocation rate in total hip arthroplasty (THA), which is crucial since hip dislocation is a leading cause of early failure in this procedure.

The article discusses a new cementless highly porous titanium DMC designed to enhance component fixation and biocompatibility, reflecting advancements in DMC technology over three generations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution and New Generation of Dual Mobility Cups. Tigani, D., Banci, L., Stallone, S., et al.[2023]

The dual mobility cup (DMC) design has significantly reduced postoperative dislocation rates and complications related to wear, such as aseptic loosening and intraprosthetic dislocation, based on over 40 years of modifications and studies.

Current literature suggests that the indications for DMC have expanded beyond just revision surgeries, indicating its potential for broader use, although long-term studies are still needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual mobility acetabular cups for total hip arthroplasty: advantages and drawbacks. Neri, T., Philippot, R., Klasan, A., et al.[2019]

A systematic review of 15 studies involving 2408 total hip arthroplasties found that dual-mobility cups (DMC) significantly reduce the risk of dislocation compared to traditional fixed-bearing designs, with a risk ratio of 0.16, indicating a much lower chance of instability post-surgery.

The findings suggest that DMCs are particularly beneficial for high-risk patients undergoing both primary and revision hip arthroplasties, although the authors call for more high-quality randomized controlled trials to further validate these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of dual-mobility cup in preventing dislocation after total hip arthroplasty: a systematic review and meta-analysis of comparative studies. Romagnoli, M., Grassi, A., Costa, GG., et al.[2022]

In a study of 215 patients undergoing primary total hip arthroplasty with dual-mobility cups, the results showed excellent clinical outcomes, with a mean Hip Harris Score of 96.6 and very few complications over an average follow-up of 70 months.

The use of dual-mobility cups effectively reduced the risk of dislocation in high-risk patients, allowing 92.8% of those who practiced extreme hip positions to return to their usual activities without issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary total hip arthroplasty: mid-term outcomes of dual-mobility cups in patients at high risk of dislocation. Assi, C., Barakat, H., Mansour, J., et al.[2022]

A dual mobility (DM) cup design in total hip arthroplasty (THA) can help reduce the risk of dislocations, especially in patients with a history of recurrent dislocations, as seen in a case involving a 52-year-old woman who experienced multiple dislocations after her initial surgery.

However, this case also highlights a rare complication known as intraprosthetic dislocation, which occurred after the DM cup was implanted, suggesting that careful management is necessary during dislocation reductions to prevent this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Intraprosthetic Dislocation of a Dual Mobility Acetabular Construct after Total Hip Arthroplasty. Tyagi, V., Akinbo, O.[2020]

Modular dual mobility cups (DMCs) in total hip arthroplasty show low dislocation rates (0.9%) and favorable clinical outcomes, making them a promising option for managing hip instability based on a review of 11 studies.

While modular DMCs are effective, it is recommended to use ceramic heads over metallic ones to minimize the risk of increased cobalt and chromium levels in the serum, highlighting a safety consideration in their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modular dual mobility articulation in primary and revision hip arthroplasty: lights and shadows. Moghnie, A., Tigani, D., Consoli, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11841846/

Ten to 15-Year Outcomes of Monoblock Uncemented Dual ... Additionally, the risk of THA dislocation reportedly increases by 1% to 1.39% for every 5 years of implant survival. The dual mobility cup (DMC) ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40270012/

Outcomes of dual mobility versus conventional total hip ... Conclusion: DM reduces dislocation and revision risks but increases heterotopic ossification and shows worse short-term functional outcomes.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S088354032400809X

Systematic Review and Meta-Analysis Outcomes of Dual ... Based on current literature, it appears DM implants are an effective modality for reducing dislocation following rTHA with reduced complication rates compared ...

4. ecios.org ecios.org/DOIx.php?id=10.4055/cios24457

Trends in Dual Mobility Cup Use and Outcomes in Primary ... Dual mobility cups (DMCs) have emerged as a promising option for enhancing hip stability in primary and revision total hip arthroplasty (THA).

5. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-025-05764-6

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12016175/

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 ...

7. sicot-j.org sicot-j.org/articles/sicotj/full_html/2024/01/sicotj240063/sicotj240063.html

Excellent survival of second-generation uncemented dual ... The dislocation was uncommon, thanks to the dual mobility concept. This second generation of uncemented DMC can be safely used in primary THA.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2352344124002814

Intraprosthetic Dislocation Following Dual Mobility Total ... Most cases of IPD in DM implants occur after failed closed reduction in the setting of a hip dislocation, suggesting an iatrogenic cause of IPD.