Analysis of Specimens From Patients With Orthopaedic Implants

• Conditions: Implants
• Interventions: Procedure: Implant

• 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

Arm && Interventions

Group	Intervention	Description
Failed implants	Implant	All patients undergoing revision of an orthopaedic implant (previously this was limited to metal hips but this has now expanded to other orthopaedic implants)
Controls with different failure modes	Implant	We will compare findings with different types of orthopaedic implants and categories of failure mode.

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