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Metal Ions in Ceramic on Metal Total Hip Arthroplasty

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01437124
Acronym
COM
Enrollment
83
Registered
2011-09-20
Start date
2011-10-31
Completion date
2012-05-31
Last updated
2016-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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. In vitro studies and small in vivo studies have revealed much lower wear, particle numbers and ion levels in ceramic on metal studies than in metal on metal bearing surfaces; however there is no large scale evidence that this is the case. The investigators currently are following up the largest worldwide series of ceramic on metal bearings and clinical results are excellent. It is important however to obtain hard data on metal ion levels in this population firstly to ensure the long term function and health of this cohort but also to provide a barometer for other surgeons who will be using a prosthesis that as yet has little in the way of long term follow up and data on ion levels in a large cohort. If the ion levels are unacceptably high then the investigators will need to follow these patients closely and offer revision surgery if there are clinical concerns. For similar reasons it is important to monitor for chromosomal abnormalities.

Interventions

None listed

Sponsors

Hussain Kazi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Cobalt Chromium Levels2 years post THRSerum cobalt chromium levels post THR

Secondary

MeasureTime frameDescription
Chromosomal Abnormality2 years post THRDeviation of karyotype from normal 2 years post THR

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
Ceramic on Metal THA
Those who have received a ceramic on metal total hip replacement
83
Total83

Baseline characteristics

CharacteristicCeramic on Metal THA
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
10 Participants
Age, Categorical
Between 18 and 65 years
73 Participants
Age, Continuous58 years
Region of Enrollment
United Kingdom
83 participants
Sex: Female, Male
Female
38 Participants
Sex: Female, Male
Male
45 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 83
serious
Total, serious adverse events
0 / 83

Outcome results

Primary

Cobalt Chromium Levels

Serum cobalt chromium levels post THR

Time frame: 2 years post THR

Population: metal ion levels

ArmMeasureValue (MEAN)
Ceramic on Metal THACobalt Chromium Levels1.06 micrograms/dl
Secondary

Chromosomal Abnormality

Deviation of karyotype from normal 2 years post THR

Time frame: 2 years post THR

Population: 24 colour FISH

ArmMeasureValue (MEAN)
Ceramic on Metal THAChromosomal Abnormality0.11 % chromosomal abberations

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026