Immunology of Failing Metal-on-Metal Hip Replacement
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| First Received Date ICMJE | January 20, 2012 | ||||
| Last Updated Date | February 8, 2012 | ||||
| Start Date ICMJE | January 2012 | ||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01517737 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Immunology of Failing Metal-on-Metal Hip Replacement | ||||
| Official Title ICMJE | Immune Cell Involvement in the Tissue Response to Metallosis in Patients With Failed Metal-on-metal Hip Replacements | ||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: blood from all patients; joint fluid, soft tissue and bone on operated patients |
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| Sampling Method | Non-Probability Sample | ||||
| 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. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 105 | ||||
| Estimated Completion Date | January 2015 | ||||
| Estimated Primary Completion Date | January 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01517737 | ||||
| Other Study ID Numbers ICMJE | 2011 Orth 04S (68-06-11), IIS2010015 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University of East Anglia | ||||
| Study Sponsor ICMJE | University of East Anglia | ||||
| Collaborators ICMJE | Depuy, Inc. | ||||
| Investigators ICMJE |
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| Information Provided By | University of East Anglia | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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