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Dual Mobility in "High Risk" Patients

NCT04092634 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2025-06-26

No results posted yet for this study

Summary

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.

Conditions

  • Dislocation, Hip

Interventions

DEVICE

Dual mobility implant

Patients that are eligible and consent to the study will be randomized to receive either a dual mobility implant or a traditional single-bearing hip implant. This group is for the dual mobility implant

DEVICE

Traditional, Single-bearing hip implant

Patients that are eligible and consent to the study will be randomized to receive either a dual mobility implant or a traditional single-bearing hip implant. This group is for the dual mobility implant

Sponsors & Collaborators

  • New York University

    collaborator OTHER

  • Rothman Institute Orthopaedics

    collaborator OTHER

  • Keck School of Medicine of USC

    collaborator OTHER

  • Rush University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2025-06-01
Completion
2035-02-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04092634 on ClinicalTrials.gov