Infection of Total Hip Joint ProsthesisNCT01517737
Immunology of Failing Metal-on-Metal Hip Replacement
An observational study of Infection of Total Hip Joint Prosthesis and Implants, run by University of East Anglia at 2 sites in United Kingdom.
Trial summary
Metal-on-metal total hip replacement (MoM THR) has been targeted at younger patients with anticipated long-term survival since the bearing surfaces wear less than the traditional metal-on-plastic (MoP) replacements. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infection of Total Hip Joint Prosthesis, Implants
- How many people
- 105 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2012to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The Ultima TPS patients are all identified and regularly followed up. Other patients will be identified from planned operating lists and waiting lists. This will be carried out by the research team.
Who may be able to join
- Patients who have undergone Ultima TPS THRs in Norwich
- Patients with a MoP THR under going revision.
- Patients undergoing primary hip replacement with osteoarthritis
- Patients with other MoM THRs undergoing revision
Who cannot join
- Patients undergoing primary THR with rheumatoid arthritis or other inflammatory arthritides, or secondary to infection
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Norfolk and Norwich University Hospital NHS Trust
Norwich, Norfolk, NR4 7UY
Simon Donell, M.D., 01603287531, simon.donell@nnuh.nhs.uk
Pinar Court
- Recruiting
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY
Pinar Court
About this study
Official title: Immune Cell Involvement in the Tissue Response to Metallosis in Patients With Failed Metal-on-metal Hip Replacements
Metal-on-metal total hip replacement (MoM THR) has been targeted at younger patients with anticipated long-term survival since the bearing surfaces wear less than the traditional metal-on-plastic (MoP) replacements. However, the production of metal ions as a result of the wear is a concern because of the possible toxicity to cells. In Norwich England a number of different metal-on-metal implants have been trialed of which one, the Ultima TPS, has had very poor results. A total of 545 patients have had 652 MoM THRs with the Ultima TPS of whom more than 20% have now been revised. There is an ongoing MHRA program to screen for problems using MRI scans with a technique developed in Norwich. Investigations so far show massive corrosion in the implants with a catastrophic immune response causing death of cells. This may include death of bone leading to fracture. In a third of patients revised there has been pain but normal plain X-rays. In some patients without pain who have been screened there are abnormal changes on an MRI scan. We wish to investigate the immune cells in patients to find out why this has happened. The study will include patients coming for a new hip to act as a comparator, as well as those with a MoM THR and patients being revised with MoM THRs, and MoP THRs. We shall also investigate patients with other MoM THRs opportunistically.
Read the detailed description
To characterize dendritic cell (DC) populations in MoM THR patients. Dendritic cells are cells that migrate from the circulating blood into tissues and mop up foreign material such as viruses with their abnormal surface makers (antigens)and metal debris, activating specialist white blood cells (such as T cells) that kill viruses and remove abnormal material.
- Conditions
- Infection of Total Hip Joint Prosthesis, Implants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection of Total Hip Joint ProsthesisStudies 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
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Depuy, Inc.
- Responsible party
- Sponsor
- Investigators
- Pinar Court, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01517737
- Sponsor's protocol ID
- 2011 Orth 04S (68-06-11)
- Other IDs
- IIS2010015
- Status last verified
- Feb 2012
- First submitted
- 20 Jan 2012
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Cell Involvement in the Tissue Response to Metallosis in Patients With Failed Metal-on-metal Hip Replacements
- ClinicalTrials.gov ID
- NCT01517737
- Acronym / sponsor ID
- 2011 Orth 04S (68-06-11)
- Conditions
- Infection of Total Hip Joint Prosthesis, Implants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Depuy, Inc.
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 25 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metal-on-metal total hip replacement (MoM THR) has been targeted at younger patients with anticipated long-term survival since the bearing surfaces wear less than the traditional metal-on-plastic (MoP) replacements. However, the production of metal ions as a result of the wear is a concern because of the possible toxicity to cells. In Norwich England a number of different metal-on-metal implants have been trialed of which one, the Ultima TPS, has had very poor results. A total of 545 patients have had 652 MoM THRs with the Ultima TPS of whom more than 20% have now been revised. There is an ongoing MHRA program to screen for problems using MRI scans with a technique developed in Norwich. Investigations so far show massive corrosion in the implants with a catastrophic immune response causing death of cells. This may include death of bone leading to fracture. In a third of patients revised there has been pain but normal plain X-rays. In some patients without pain who have been screened there are abnormal changes on an MRI scan. We wish to investigate the immune cells in patients to find out why this has happened. The study will include patients coming for a new hip to act as a comparator, as well as those with a MoM THR and patients being revised with MoM THRs, and MoP THRs. We shall also investigate patients with other MoM THRs opportunistically.
Detailed description
To characterize dendritic cell (DC) populations in MoM THR patients. Dendritic cells are cells that migrate from the circulating blood into tissues and mop up foreign material such as viruses with their abnormal surface makers (antigens)and metal debris, activating specialist white blood cells (such as T cells) that kill viruses and remove abnormal material.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The Ultima TPS patients are all identified and regularly followed up. Other patients will be identified from planned operating lists and waiting lists. This will be carried out by the research team.
Key inclusion criteria (4 listed)
- Patients who have undergone Ultima TPS THRs in Norwich
- Patients with a MoP THR under going revision.
- Patients undergoing primary hip replacement with osteoarthritis
- Patients with other MoM THRs undergoing revision
Key exclusion criteria (1 listed)
- Patients undergoing primary THR with rheumatoid arthritis or other inflammatory arthritides, or secondary to infection
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
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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.
Pinar Court principal investigator
University of East Anglia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection of Total Hip Joint Prosthesis and Implants, run by University of East Anglia at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon Donell, M.D. (01603287531, simon.donell@nnuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 9 Feb 2012.