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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

Must not have

Conversion of non-arthroplasty femoral neck fracture fixation to THA

Patients where the surgeon makes the intraoperative decision to use a constrained liner will be excluded.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I am under 18 years old.

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I have had a total hip replacement.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Prosthetic Dislocation

Secondary study objectives

Complications

Prosthesis Loosening

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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 / 7Eligibility criteria met