Dual Mobility Cups vs. Single-Bearing Cups for Hip Dislocation

Recruiting at 1 trial location

Overseen By Craig Della Valle, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rush University Medical Center

Disqualifiers: Under 18, Primary THA, 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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

322 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of hip implants used in revision hip replacement surgery to determine which better prevents dislocations in the first year post-surgery. One group will receive a dual mobility implant, designed to allow more movement and reduce dislocation risk, while the other group will receive a conventional single-bearing implant. The trial seeks patients scheduled for a revision hip replacement with a hip socket that can accommodate a large implant head. Participants have the opportunity to potentially benefit from a new implant design that could enhance hip stability and quality of life. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand its benefits for 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.

What is the safety track record for these treatments?

Research has shown that dual mobility implants are generally well-received by patients. Studies have found that these implants last a long time and help lower the risk of hip dislocation after surgery. For instance, one study found that patients using these implants in their first hip replacement surgeries had low rates of instability and dislocation, indicating they are a safe option for many people.

While no treatment is without risk, the current data on dual mobility implants remains encouraging. Evidence shows good results, with patients experiencing fewer complications compared to some other types of implants. This makes dual mobility implants a promising choice for those considering hip replacement surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about dual mobility implants for hip dislocation because they offer a unique design that aims to reduce the risk of dislocation compared to conventional single-bearing implants. Unlike traditional options that rely on a single bearing surface, dual mobility implants feature an additional bearing, which provides greater stability and range of motion. This innovative approach could potentially improve patient outcomes by lowering the chances of postoperative complications like dislocation, making recovery smoother and more reliable.

What evidence suggests that dual mobility implants might be an effective treatment for hip dislocation?

This trial will compare dual mobility implants with conventional single-bearing implants for hip dislocation. Studies have shown that dual mobility implants, which participants in this trial may receive, can reduce the risk of hip dislocation after surgery. Research indicates that these implants help maintain hip stability, leading to better outcomes for patients undergoing hip replacements. Specifically, one study found that dual mobility cups have a low rate of dislocation and instability, making them a promising option for hip surgeries. Another study showed that dual mobility implants have good long-term results, with patients experiencing fewer complications over time. Overall, evidence supports the effectiveness of dual mobility implants in reducing hip dislocation and improving patient outcomes. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need a second hip replacement surgery and can fit at least a 36mm femoral head in their existing hip socket. It's not for first-time hip replacements or those converting from non-arthroplasty fracture fixations to total hip arthroplasty.

Inclusion Criteria

My hip replacement can fit a femoral head of at least 36mm.

I am having a hip replacement redone due to an infection.

Exclusion Criteria

I am willing to participate in the clinical trial.

I am having a hip replacement after a previous hip fracture repair.

I am not excluded if my surgeon decides to use a constrained liner during surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recovery

Participants undergo revision total hip arthroplasty (THA) with either dual mobility or single bearing design. Postoperative hip precautions are followed for 6 weeks.

6 weeks

Follow-up

Participants are monitored for safety and effectiveness, including prosthetic dislocation and complications, with routine radiographs and clinic visits.

20 years

What Are the Treatments Tested in This Trial?

Interventions

• Conventional, single-bearing implant
• Dual Mobility Implant

Trial Overview

The study compares two types of implants in revision total hip arthroplasty: dual mobility cups versus conventional single-bearing cups with large heads (36mm/40mm). The goal is to see if the dual mobility reduces dislocation rates within the first year after surgery.

How Is the Trial Designed?

Group I: Dual Mobility Experimental Treatment 1 Intervention

If patients are randomized to the dual mobility cohort, they will receive a dual mobility prosthesis at the surgeon's discretion. All surgeries will be performed via the posterior approach, per the participating surgeon's usual standard. Patients will be on postoperative hip precautions for 6 weeks, per departmental protocol. No braces will be utilized.

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

If patients are randomized to the conventional, single bearing cohort, surgeons will use their preferred implant design at their discretion using a 36 or 40mm head, depending on the diameter of the cup and manufacturer specifications. All surgeries will be performed via the posterior approach, per the participating surgeon's usual standard. Patients will be on postoperative hip precautions for 6 weeks, per departmental protocol. No braces will be utilized.

Dual Mobility Implant is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Dual Mobility Cup for:

• Revision total hip arthroplasty
• Failed large head metal-on-metal bearings
• Complex acetabular reconstructions

Approved in United States as Dual Mobility Implant for:

• Revision total hip arthroplasty
• Failed large head metal-on-metal bearings
• Complex acetabular reconstructions

Approved in Canada as Dual Mobility Acetabular Cups for:

• Revision total hip arthroplasty
• Failed large head metal-on-metal bearings
• Complex acetabular reconstructions

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

7

Recruited

1,000+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Rothman Institute Orthopaedics

Collaborator

Trials

127

Recruited

22,600+

Published Research Related to This Trial

In a study of 125 patients who underwent total hip arthroplasty using dual mobility cups (DMCs), there were no dislocations, aseptic loosening, or infections reported, indicating high safety and efficacy of this implant in a population with specific hip movement rituals.

The mean modified Hip Harris Score was 94.8, suggesting excellent functional outcomes, with 90% of patients who practiced extreme hip positions feeling their hip was 'forgotten' after surgery, allowing them to return to their daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality Rate and Mid-Term Outcomes of Total Hip Arthroplasty Using Dual Mobility Cups for the Treatment of Femoral Neck Fractures in a Middle Eastern Population. Assi, CC., Barakat, HB., Caton, JH., et al.[2019]

In a study of 8968 patients (2242 with dual mobility cups and 6726 with conventional total hip arthroplasty) for acute femoral neck fractures, the revision rates for both types of implants were similar after 5 years, regardless of whether a posterior or lateral surgical approach was used.

Specifically, the cumulative revision rates due to dislocation were lower for dual mobility cups compared to conventional implants, but the overall differences were not statistically significant, indicating that both options are equally effective in preventing revisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual mobility cups do not reduce the revision risk for patients with acute femoral neck fracture: A matched cohort study from the Swedish Arthroplasty Register. Rogmark, C., Nauclér, E.[2022]

Dual-mobility cups (DMCs) have been shown to provide a high range of motion and reduce dislocation risk in hip arthroplasty, making them particularly beneficial for patients at high risk for dislocation, such as those with obesity or neuromuscular disorders.

While DMCs have demonstrated low dislocation rates and high mid-term survival rates, long-term data on their effectiveness, especially in primary hip replacements, is still limited, highlighting the need for further research on newer designs and materials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual-Mobility Cups in Primary Total Hip Arthroplasty. Bellova, P., Goronzy, J., Riedel, R., et al.[2023]

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]

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]

The dual-mobility acetabular cup (DMC) significantly reduces the risk of revision surgery compared to conventional total hip arthroplasty (THA), with an adjusted hazard ratio of 0.75 based on a study of 4,520 hip fractures.

DMCs also show a notably lower risk of revision due to dislocation (AHR = 0.45), indicating improved stability, although there is a higher risk of death associated with DMC use (AHR = 1.49).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced Revision Risk for Dual-Mobility Cup in Total Hip Replacement Due to Hip Fracture: A Matched-Pair Analysis of 9,040 Cases from the Nordic Arthroplasty Register Association (NARA). Jobory, A., Kärrholm, J., Overgaard, S., et al.[2020]

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]

The contemporary dual mobility cup (DMC) significantly reduces the dislocation rate in patients undergoing total hip arthroplasty, making it a valuable option for managing instability in both primary and revision surgeries.

Current studies indicate that midterm survivorship of the DMC is comparable to other hip joint designs, with reduced occurrences of intra-prosthetic dislocation, wear, and loosening, highlighting improvements in the latest generation of DMCs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evolution of outcomes and indications for the dual-mobility cup: a systematic review. Batailler, C., Fary, C., Verdier, R., et al.[2022]

Citations

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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) ...

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

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This matched study shows that there is no difference in local complication rates between DM and conventional THA articulations.

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Cemented dual-mobility total hip arthroplasty cups in a ...

The combination of custom-made (CM) acetabular components with cemented dual mobility (DM) cups may improve postoperative outcomes in this ...

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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.

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Dual Mobility Cups for Preventing Early Hip Arthroplasty ...

Early recurrent dislocation may lead to revision surgery and is associated with high risk of complications. The etiology of implant instability is ...

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pmc.ncbi.nlm.nih.gov

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sicot-j.org

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Excellent survival of second-generation uncemented dual ...

This study aimed to compare the revision rate and long-term survival between two generations of uncemented dual mobility cup (DMC) from the same manufacturer.

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Outcomes of dual mobility versus conventional total hip ...

The main outcomes analyzed in this meta-analysis were: (1) dislocation infection, (2) revision surgery, (3) infection, (4) heterotopic ...