Analysis of Specimens From Patients With Orthopaedic Implants

April 11, 2017 updated by: Professor Alister Hart, Royal National Orthopaedic Hospital NHS Trust
The investigators aim to determine the cause of failure of orthopaedic implants using multi-disciplinary analysis of data from patients who have undergone revision.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • London
      • Stanmore, London, United Kingdom, HA7 4LP
        • Recruiting
        • Royal National Orthopaedic Hospital
        • Contact:
        • Sub-Investigator:
          • John Skinner, FRCS(Orth)
        • Principal Investigator:
          • Alister Hart, MD, FRCSG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients will be both male and female, aged between 11-70 years.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cause of failure
Time Frame: At time of failure which is likely to be an average of 5 years post operative
At time of failure which is likely to be an average of 5 years post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal National Orthopaedic Hospital NHS Trust

Collaborators

Massachusetts General Hospital
Coxa, Hospital for Joint Replacement

Investigators

  • Principal Investigator: Alister Hart, FRCSG(Orth), RNOH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

September 30, 2015

First Submitted That Met QC Criteria

October 1, 2015

First Posted (Estimate)

October 2, 2015

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 11, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • RNOH LIRC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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