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

Trial Summary

What is the purpose of this trial?

The aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (THA) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). We hypothesize the use of dual-mobility components in revision THA will be associated with a lower dislocation rate in the first year following surgery.

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 data supports the effectiveness of this treatment for reducing hip dislocation?

Research shows that dual mobility cups (DMC) can reduce the risk of hip dislocation in patients undergoing total hip arthroplasty, especially those at high risk of instability. Studies indicate that DMCs are effective in lowering dislocation rates compared to conventional implants. ^{1 2 3 4 5}

Is the dual mobility cup generally safe for use in hip replacement surgeries?

Research shows that dual mobility cups (DMCs) are generally safe and can reduce the risk of hip dislocation in patients undergoing hip replacement surgery. Studies report low dislocation rates and high survival rates in the mid-term follow-up, although long-term data is still limited. ^{2 4 5 6 7}

How is the dual mobility cup treatment different from other hip dislocation treatments?

Dual mobility cups (DMCs) are unique because they are designed to reduce the risk of hip dislocation by allowing a greater range of movement and increasing stability, which is particularly beneficial for patients at high risk of dislocation. Unlike traditional hip implants, DMCs have a special design that includes a mobile polyethylene liner inside a metal shell, which helps prevent dislocation by increasing the 'jumping distance' (the distance the hip joint can move before dislocating). ^{1 2 3 5 8}

Eligibility Criteria

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

I am over 18 and scheduled for a specific hip replacement surgery revision.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. Netherlands 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. [2022]

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

Primary total hip arthroplasty: mid-term outcomes of dual-mobility cups in patients at high risk of dislocation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Modular dual mobility articulation in primary and revision hip arthroplasty: lights and shadows. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

The evolution of outcomes and indications for the dual-mobility cup: a systematic review. [2022]

5. United States 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. [2019]

6. United States 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). [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Dual-Mobility Cups in Primary Total Hip Arthroplasty. [2023]

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

Evolution and New Generation of Dual Mobility Cups. [2023]