322 Participants Needed

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

Recruiting at 1 trial location
AD
CD
Overseen ByCraig Della Valle, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Rush University Medical Center
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
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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).23678

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.23568

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.
See 2 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Dual MobilityExperimental Treatment1 Intervention
Group II: Conventional, Single-bearing hip implantActive Control1 Intervention

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

πŸ‡ͺπŸ‡Ί
Approved in European Union as Dual Mobility Cup for:
πŸ‡ΊπŸ‡Έ
Approved in United States as Dual Mobility Implant for:
πŸ‡¨πŸ‡¦
Approved in Canada as Dual Mobility Acetabular Cups for:

Find a Clinic Near You

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

Citations

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]
Primary total hip arthroplasty: mid-term outcomes of dual-mobility cups in patients at high risk of dislocation. [2022]
Modular dual mobility articulation in primary and revision hip arthroplasty: lights and shadows. [2023]
The evolution of outcomes and indications for the dual-mobility cup: a systematic review. [2022]
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]
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]
Dual-Mobility Cups in Primary Total Hip Arthroplasty. [2023]
Evolution and New Generation of Dual Mobility Cups. [2023]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceΒ·Privacy PolicyΒ·CookiesΒ·Security