Contact information
Type
Scientific
Primary contact
Mr MH Stone
ORCID ID
Contact details
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 113 392 4769
martin.stone@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3298
Study information
Scientific title
Patient specific biological responses to total joint replacements
Acronym
Patient specific biological responses to total joint replacements
Study hypothesis
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.
Ethics approval
MREC approved (ref: CA03/008)
Study design
Single centre non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Cytokine released by primary human macrophages from individual patients in response to 100 cubic micrometers of polyethylene.
Secondary outcome measures
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
Overall trial start date
01/09/2009
Overall trial end date
30/06/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with a Charnley hip prosthesis that has been in situ for 10 years
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned sample size: 200
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/2009
Recruitment end date
30/06/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Great George Street
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
Woodhouse Lane
Leeds
LS2 9JT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Engineering and Physical Sciences Research Council (EPSRC) (UK)
Alternative name(s)
EPSRC
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary