NCT02566694

Analysis of Specimens From Patients With Orthopaedic Implants

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Royal National Orthopaedic Hospital NHS Trust · Academic / Other
• Sex: All
• Age: 11 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Implants

Interventions

Type	Name	Description
PROCEDURE	Implant	orthopaedic implant

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-03-01
• Completion: 2020-03-01
• First posted: 2015-10-02
• Last updated: 2017-04-12

Locations

1 site across 1 country: United Kingdom