Patient specific biological responses to total joint replacements
| ISRCTN | ISRCTN21046383 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21046383 |
| Protocol serial number | 3298 |
| Sponsor | University of Leeds (UK) |
| Funder | Engineering and Physical Sciences Research Council (EPSRC) (UK) |
- 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
Scientific
Great George Street
Leeds
LS1 3EX
United Kingdom
| Phone | +44 113 392 4769 |
|---|---|
| martin.stone@leedsth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre non-randomised interventional treatment trial |
| Secondary study design | Non randomised study |
| Scientific title | Patient specific biological responses to total joint replacements |
| Study acronym | Patient specific biological responses to total joint replacements |
| Study objectives | 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(s) | MREC approved (ref: CA03/008) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Cytokine released by primary human macrophages from individual patients in response to 100 cubic micrometers of polyethylene. |
| Key secondary outcome measure(s) |
1. Correlation of genotype with clinical outcome of THR surgery |
| Completion date | 30/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | |
| Target sample size at registration | 200 |
| Key inclusion criteria | Patients with a Charnley hip prosthesis that has been in situ for 10 years |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 30/06/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Great George Street
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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.
