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Metal Ions in Ceramic on Metal Total Hip Arthroplasty

NCT01437124 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 83

Last updated 2016-06-06

Study results available
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Summary

The investigators aim to measure the blood levels of certain metals in a group of patients all of whom have had a ceramic on metal total hip replacement. This new bearing surface (joint) is relatively new and the investigators are currently following up the largest cohort in the world. Clinical results are currently excellent at 2 years in all patients, however the investigators are mindful of the lessons learned from the high failure rate of several designs of metal on metal hip replacements as well as several in vitro reports and one in vivo case report of elevated metal levels in this particular implant. The investigators feel it is important to measure the metal ion levels in our group to ascertain and compare these with reference standards. Once performed the investigators can relate ion levels to function and x ray changes and provide useful longterm data to the patients and the wider medical community as to whether this bearing surface is safe in the long term or whether it's use should be abandoned. This is useful as there are numerous groups implanting this device in the UK and in addition it has just been awarded FDA approval in the USA - its use is likely to flourish.

Conditions

Sponsors & Collaborators

  • Hussain Kazi

    lead OTHER

Principal Investigators

  • Fintan A Carroll, MBBS, FRCS · Consultant Orthopaedic Surgeon

  • Hussain A Kazi, MBChB,FRCS · Specialist Registrar, Trauma & Orthopaedics

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT01437124 on ClinicalTrials.gov