Condition category
Musculoskeletal Diseases
Date applied
24/06/2010
Date assigned
24/06/2010
Last edited
11/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.leeds.ac.uk/

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

Publication citations

Additional files

Editorial Notes

11/08/21016: No publications found in PubMed, verifying study status with principal investigator.