Mode
Text Size
Log in / Sign up
N/A N=83

Metal Ions in Ceramic on Metal Total Hip Arthroplasty

Osteoarthritis · Avascular Necrosis · Rheumatoid Arthritis · Developmental Dysplasia of the Hip

Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Cobalt Chromium Levels — 1.06 micrograms/dl

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Hussain Kazi
Primary completion
May 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Cobalt Chromium Levels
1.06
SECONDARY
Chromosomal Abnormality
0.11

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01437124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search