Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-01-03 @ 5:53 AM
Study NCT ID:
NCT02566694
Status:
UNKNOWN
Last Update Posted:
2017-04-12
First Post:
2015-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Specimens From Patients With Orthopaedic Implants
Sponsor:
Royal National Orthopaedic Hospital NHS Trust
Organization:
Study Overview
Official Title:
Analysis of Specimens From Patients With Orthopaedic Implants
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: