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Serum Level of Cobalt and Chromium After Ceramic on Metal Articulation Total Hip Arthroplasty

NCT02346513 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 228

Last updated 2015-01-27

No results posted yet for this study

Summary

Primary objectives:

1. To measure serum metal ion levels (blood Chromium (Cr) and Cobalt (Co) ion concentration) in patients that received the Ceramic on Metal arthroplasty of hip and who have well functioning primary total hip arthroplasties during short and medium- term follow up time points.
2. To compare blood ion levels of patient that received COM arthroplasty with the blood ion levels of patient receiving non-COM standard total hip arthroplasty (a Metal on polyethylene or ceramic on polyethylene total hip arthroplasty) at short- term and medium-term follow up time points .

Secondary Objective:

1\) To determine whether these blood levels correlate with any device specific factors such as: component position, size and type, wear rate and/or patient specific factors such as gender, body mass index, age and activity level.

Conditions

  • Hip Replacement Arthroplasty

Interventions

DEVICE

Ceramic on Metal Articulation

Patients have THA with ceramic on metal articulation

DEVICE

Non-Ceramic on Metal Articulation

Patients have THA with non-ceramic on metal articulation

Sponsors & Collaborators

  • Korea University Guro Hospital

    lead OTHER

Principal Investigators

  • Won Yong Shon, Professor · Korea University Guro Hospital

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-05-31
Completion
2015-08-31

Countries

  • South Korea

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 NCT02346513 on ClinicalTrials.gov