Patient specific biological responses to total joint replacements

ISRCTN ISRCTN21046383
DOI https://doi.org/10.1186/ISRCTN21046383
Secondary identifying numbers 3298
Submission date
24/06/2010
Registration date
24/06/2010
Last edited
06/12/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr MH Stone
Scientific

Great George Street
Leeds
LS1 3EX
United Kingdom

Phone +44 113 392 4769
Email martin.stone@leedsth.nhs.uk

Study information

Study designSingle centre non-randomised interventional treatment trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Scientific titlePatient specific biological responses to total joint replacements
Study acronymPatient specific biological responses to total joint replacements
Study objectivesThis 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(s)MREC approved (ref: CA03/008)
Health condition(s) or problem(s) studiedTopic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal
InterventionPatients 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 typeOther
Primary outcome measureCytokine released by primary human macrophages from individual patients in response to 100 cubic micrometers of polyethylene.
Secondary outcome measures1. 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 study start date01/09/2009
Completion date30/06/2010

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsPlanned sample size: 200
Key inclusion criteriaPatients with a Charnley hip prosthesis that has been in situ for 10 years
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/09/2009
Date of final enrolment30/06/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Great George Street
Leeds
LS1 3EX
United Kingdom

Sponsor information

University of Leeds (UK)
University/education

Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom

Website http://www.leeds.ac.uk/
ROR logo "ROR" https://ror.org/024mrxd33

Funders

Funder type

Research council

Engineering and Physical Sciences Research Council (EPSRC) (UK)
Government organisation / National government
Alternative name(s)
UKRI Engineering and Physical Sciences Research Council, Engineering and Physical Sciences Research Council - UKRI, Engineering & Physical Sciences Research Council, EPSRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

06/12/2019: No publications found, all search options exhausted, study status unverified.
06/12/2019: No publications found, verifying study status with principal investigator.
11/08/2016: No publications found in PubMed, verifying study status with principal investigator.