Dual Mobility Implants for Hip Dislocation

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

412 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this study is to compare clinical outcomes of patients considered to be high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single bearing design.

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 data supports the effectiveness of dual mobility implants for hip dislocation?

Research shows that dual mobility cups (DMCs) significantly reduce the rate of hip dislocation in both primary and revision total hip arthroplasties (THAs). They are especially beneficial for patients at high risk of dislocation, offering a greater range of motion and stability compared to traditional hip implants. ^{1 2 3 4 5}

Is the dual mobility implant generally safe for humans?

Dual mobility implants are generally considered safe and have been shown to reduce the risk of hip dislocation compared to traditional implants. However, there are concerns about increased wear and loosening over time, so they should be used carefully, especially in younger patients. ^{1 2 3 5 6}

How does the dual mobility implant treatment differ from other treatments for hip dislocation?

The dual mobility implant is unique because it features a design with a small femoral head that moves within a larger polyethylene insert, which then moves within an outer shell. This design helps reduce the risk of hip dislocation compared to traditional single-bearing hip implants, making it particularly beneficial for patients at high risk of dislocation. ^{1 3 5 6 7}

Eligibility Criteria

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 am scheduled for or have had a hip replacement revision.

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. Germany 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Dual mobility acetabular cups for total hip arthroplasty: advantages and drawbacks. [2019]

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

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

6. Germany pubmed.ncbi.nlm.nih.gov

Biomechanical concept and clinical outcome of dual mobility cups. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Early Intraprosthetic Dislocation of a Dual Mobility Acetabular Construct after Total Hip Arthroplasty. [2020]