Analysis of Specimens From Patients With Orthopaedic Implants

• Conditions: Implants

• Registration Number: NCT02566694
• Lead Sponsor: Royal National Orthopaedic Hospital NHS Trust

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

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-02
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-11
• Last Update Posted: 2017-04-12
• Primary Completion: 2018-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• All patients undergoing revision of an orthopaedic implant (previously this was limited to metal hips but this has now expanded to other orthopaedic implants)

Exclusion Criteria

• Patients not consenting to the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cause of failure	At time of failure which is likely to be an average of 5 years post operative

Trial Locations

Locations (1)

Royal National Orthopaedic Hospital; 🇬🇧 Stanmore, London, United Kingdom