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ISRCTN
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ISRCTN21046383
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ClinicalTrials.gov identifier
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Public title
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Patient specific biological responses to total joint replacements
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Scientific title
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Acronym
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Patient specific biological responses to total joint replacements
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Serial number at source
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3298
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Study hypothesis
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This research will be carried out at the University of Leeds and is a collaborative research programme between the Institute of Medical and Biological Engineering and Consultant Orthopaedic Surgeons, Mr Martin Stone (Chapel Allerton) and Mr David Shaw (Bradford Royal Infirmary). Patients will be recruited from two groups, patients awaiting hip replacement operations and patients with long-term polyethylene implants. Approximately 100 patients from each group will be studied.
Patients awaiting hip replacement will have an additional 30 ml of blood collection pre-operatively. Inclusion in the study will not affect patient care in any way, and the surgical procedure will be the same whether the patient chooses to participate in the study or not. Patients with long-term implants will be invited by letter to attend the clinic to volunteer the additional 30 ml blood sample.
The blood samples will be processed by the researchers at the University of Leeds, where the white blood cells will be isolated and used in culture with real wear particles generated by articulation. Cytokine production will be measured by enzyme-linked immunospecific assay (ELISA). Approximately 1 x 10^6 cells will be stored for genetic analysis to determine specific base changes in the DNA. The clinical results of the patients will be followed in follow-up clinics.
The control group will comprise approximately 30 healthy volunteers from the research group (iMBE, Faculty of Biological Sciences & School of Mechanical Engineering). A single 30 ml blood sample will be collected from each control subject by trained personel. Collection of blood samples for research purposes is performed routinely and approval has been awarded from the Faculty of Biological Sciences Research Ethics Committee.
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Lay summary
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Ethics approval
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MREC approved (ref: CA03/008)
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Study design
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Single centre non-randomised interventional treatment trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
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Participants - inclusion criteria
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Patients with a Charnley hip prosthesis that has been in situ for 10 years
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/09/2009
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Anticipated end date
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30/06/2009
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Planned sample size: 200
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Interventions
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In addition to the usual blood tests on addmission, an extra 30 ml volume of blood is required pre-operatively for the research project. The blood will be drawn from a needle already inserted, or to be inserted for routine samples.
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Primary outcome measure(s)
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Cytokine released by primary human macrophages from individual patients in response to 100 cubic micrometers of polyethylene.
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Secondary outcome measure(s)
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1. Correlation of genotype with clinical outcome of THR surgery
2. Correlation of phenotypic response to cytokine promoter polymorphism genotype
3. Number of patients that are low responders, intermediate responders and aggressive responders to wear particles
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Sources of funding
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Engineering and Physical Sciences Research Council (EPSRC) (UK)
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Trial website
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Publications
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Contact name
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Mr
MH
Stone
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Address
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Great George Street
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City/town
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Leeds
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Zip/Postcode
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LS1 3EX
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Country
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United Kingdom
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Email
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martin.stone@leedsth.nhs.uk
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Sponsor
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University of Leeds (UK)
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Address
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Woodhouse Lane
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City/town
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Leeds
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Zip/Postcode
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LS2 9JT
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Country
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United Kingdom
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Sponsor website:
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http://www.leeds.ac.uk/
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Date applied
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24/06/2010
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Last edited
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24/06/2010
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Date ISRCTN assigned
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24/06/2010
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