Analysis of Specimens From Patients With Orthopaedic Implants
NCT ID: NCT02566694
Last Updated: 2017-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2015-03-31
2020-03-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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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)
Implant
orthopaedic implant
Controls with different failure modes
We will compare findings with different types of orthopaedic implants and categories of failure mode.
Implant
orthopaedic implant
Interventions
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Implant
orthopaedic implant
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
11 Years
70 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Coxa, Hospital for Joint Replacement
OTHER
Royal National Orthopaedic Hospital NHS Trust
OTHER
Responsible Party
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Professor Alister Hart
Professor of Orthopaedics
Principal Investigators
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Alister Hart, FRCSG(Orth)
Role: PRINCIPAL_INVESTIGATOR
RNOH
Locations
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Royal National Orthopaedic Hospital
Stanmore, London, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RNOH LIRC
Identifier Type: -
Identifier Source: org_study_id
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