OsteoarthritisCOMNCT01437124
Metal Ions in Ceramic on Metal Total Hip Arthroplasty
An observational study of Osteoarthritis and Avascular Necrosis, run by Hussain Kazi at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis
- How many people
- 83 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2011to May 2012
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those who have received a ceramic on metal total hip arthroplasty
Who may be able to join
- 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
Who cannot join
- Hip arthroplasty other than ceramic on metal bearing
- Mentally infirm / incapacitated
- Incomplete history or physical examination
- Unwillingness to participate in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wirral University Teaching Hospitals NHS Foundation Trust
Metropolitan Borough of Wirral, Merseyside, CH49 5PE
About this study
Official title: Measurement of Metal Ion Levels and Chromosome Abnormalities in Ceramic on Metal Total Hip Arthroplasty in Vivo
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.
Read the 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.
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Developmental Dysplasia of the Hip
- Medical subject headings
- Osteoarthritis, Osteonecrosis, Arthritis, Rheumatoid, Developmental Dysplasia of the Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ceramic on metal THA | Those who have received a ceramic on metal total hip replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobalt Chromium Levels
Serum cobalt chromium levels post THR
Measured: 2 years post THR
Secondary outcomes (1)
Chromosomal Abnormality
Deviation of karyotype from normal 2 years post THR
Measured: 2 years post THR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hussain Kazi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hussain Kazi, Wirral University Teaching Hospital NHS Trust
- Investigators
- Fintan A Carroll, MBBS, FRCS, Study director, Consultant Orthopaedic SurgeonHussain A Kazi, MBChB,FRCS, Principal investigator, Specialist Registrar, Trauma & Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437124
- Sponsor's protocol ID
- 960558216
- Acronym
- COM
- Status last verified
- Apr 2016
- First submitted
- 16 Sep 2011
- Last updated
- 6 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Metal Ion Levels and Chromosome Abnormalities in Ceramic on Metal Total Hip Arthroplasty in Vivo
- ClinicalTrials.gov ID
- NCT01437124
- Acronym / sponsor ID
- COM / 960558216
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Developmental Dysplasia of the Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Hussain KaziUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 20 Sep 2011 (estimated)
- Results
- Posted 6 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ceramic on metal THA | – | –Those who have received a ceramic on metal total hip replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those who have received a ceramic on metal total hip arthroplasty
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Hip arthroplasty other than ceramic on metal bearing
- Mentally infirm / incapacitated
- Incomplete history or physical examination
- Unwillingness to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cobalt Chromium Levels
Time frame: 2 years post THR
Serum cobalt chromium levels post THR
1 secondary outcome
Chromosomal Abnormality
Time frame: 2 years post THR
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fintan A Carroll, MBBS, FRCS study director
Consultant Orthopaedic Surgeon
Hussain A Kazi, MBChB,FRCS principal investigator
Specialist Registrar, Trauma & Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Avascular Necrosis, run by Hussain Kazi at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobalt Chromium Levels (time frame: 2 years post THR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2016.