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Clinical Trial Summary

The investigators aim to determine the cause of failure of orthopaedic implants using multi-disciplinary analysis of data from patients who have undergone revision.


Clinical Trial Description

The following tests will then be arranged:

- Tribological assessment. The investigators will measure the wear of the explants using: 1) 'out of roundness'; and 2) Coordinate measuring. Semi-quantitative assessment of damage to the explants will also be conducted

- Histological assessment. Tissue sent in formalin may determine the biomarker of diagnosis of metal ion synovitis where applicable

- Metal ion measurement in body fluids where applicable (in patients with metal implants)

- Diamond Light Source (this was approved in the 1st amendment). The tests will involve subjecting formalin fixed tissue to the high energy electron beam of the Diamond Light Source

- Destructive testing of the implant is allowed by the patient (after all non-destructive tests have been performed)

- Protein analysis of fluid and tissue if provided

- Titanium levels from blood samples if provided

- Gene expression testing to assess and understand mechanism of inflammation where applicable ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02566694
Study type Observational
Source Royal National Orthopaedic Hospital NHS Trust
Contact Iva Hauptmannova, BSc
Email Iva.Hauptmannova@rnoh.nhs.uk
Status Recruiting
Phase N/A
Start date March 2015
Completion date March 2020

See also
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