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A Prospective Randomized Controlled Trial of Dual-Mobility Components in Primary THA

NCT03371212 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-01-08

No results posted yet for this study

Summary

The aim of this study is to determine if the use of a modular dual mobility bearing is associated with clinically important increases in serum metal levels.

Conditions

  • Serum Metal Levels, Specifically Cobalt, Chromium, and Titanium

Interventions

DEVICE

Dual mobility cohort

Patients will receive the Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components \> 52mm), polyethylene bearing, and G7 acetabular shell.

DEVICE

Conventional cohort

Patients will receive a Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components \> 52mm), polyethylene bearing, and G7 acetabular shell

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • Rush University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2035-12-01
Completion
2036-12-01
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 NCT03371212 on ClinicalTrials.gov