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Joint Replacement Implant

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

Phase 4

Recruiting

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any patient older than 18 years of age scheduled for a revision THA, including revision of both components, conversion of a hip resurfacing to THA, conversion of a hemiarthroplasty to THA, and revision of single components which allow implantation of dual-mobility bearings

Only patients with an acetabular shell diameter capable of accommodating at least a 36mm femoral head will be included

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 years

Awards & highlights

Study Summary

This trial will compare patients who undergo a revision THA with a dual mobility bearing to those with a single bearing design - we think the former will have a lower dislocation rate.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed, typical risks may include infection, pain at the implant site, dislocation of the new joint, wear and tear on the implant, and possible need for further surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Prosthetic Dislocation

Secondary outcome measures

Complications

Prosthesis Loosening

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Dual MobilityExperimental Treatment1 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 implantActive Control1 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthOTHER

1,368 Previous Clinical Trials

839,404 Total Patients Enrolled

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

163,179 Total Patients Enrolled

1 Trials studying Hip Dislocation

412 Patients Enrolled for Hip Dislocation

Rothman Institute OrthopaedicsOTHER

121 Previous Clinical Trials

21,256 Total Patients Enrolled

1 Trials studying Hip Dislocation

412 Patients Enrolled for Hip Dislocation

Media Library

Dual Mobility Implant (Joint Replacement Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04090359 — Phase 4

Hip Dislocation Research Study Groups: Dual Mobility, Conventional, Single-bearing hip implant

Hip Dislocation Clinical Trial 2023: Dual Mobility Implant Highlights & Side Effects. Trial Name: NCT04090359 — Phase 4

Dual Mobility Implant (Joint Replacement Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04090359 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently involved in this experiment?

"Affirmative. Clinicaltrials.gov attests that this medical trial, which originally opened its doors on September 1st 2017, is actively searching for 322 participants from two separate centres."

Answered by AI

Is this clinical research currently enlisting participants?

"Affirmative, according to clinicaltrials.gov this active study is seeking out participants. Established on September 1st 2017 and recently revised November 16th 2022, the experiment requires 322 people to be enrolled from two different sites."

Answered by AI

Is Dual Mobility Implant associated with any adverse outcomes for patients?

"The safety of the Dual Mobility Implant was rated a 3 on our scale due to it being in its fourth phase of clinical trials and already having been approved."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dual Mobility Acetabular Cups in Revision TJA

2017. "Dual Mobility Acetabular Cups in Revision TJA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04090359.

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