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Clinical Trials/NCT01437124
NCT01437124CompletedNot Applicable

Measurement of Metal Ion Levels and Chromosome Abnormalities in Ceramic on Metal Total Hip Arthroplasty in Vivo

Hussain Kazi1 site in 1 country83 target enrollmentStarted: October 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
83
Locations
1
Primary Endpoint
Cobalt Chromium Levels

Study Overview

Brief 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.

Detailed Description

PURPOSE & DESIGN:

The investigators are currently following up a cohort of patients all of whom have had a metal on ceramic total hip arthroplasty.

This new bearing couple has been approved for use in the UK for some time and has recently achieved USA FDA approval.

The attraction of this bearing couple is a low rate of wear with reduced complications associated with ceramic on ceramic bearing such as bearing fracture.

Of recent media attention has been the unacceptably high failure of the DePuy ASR metal on metal hip resurfacing. This metal on metal bearing couple has been associated with increased ion levels and chromosome abnormalities in vivo.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Over 18 years of age
  • Complete history and physical examination
  • Previously performed ceramic on metal total hip replacement
  • An understanding of the purpose of the study and signed consent form

Exclusion Criteria

  • Hip arthroplasty other than ceramic on metal bearing
  • Mentally infirm / incapacitated
  • Incomplete history or physical examination
  • Unwillingness to participate in the study

Outcomes

Primary Outcomes

Cobalt Chromium Levels

Time Frame: 2 years post THR

Serum cobalt chromium levels post THR

Secondary Outcomes

  • Chromosomal Abnormality(2 years post THR)

Investigators

Sponsor
Hussain Kazi
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Hussain Kazi

Specialist Registrar, Trauma and Orthopaedics

Wirral University Teaching Hospital NHS Trust

Study Sites (1)

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