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Analysis of Specimens From Patients With Orthopaedic Implants

Analysis of Specimens From Patients With Orthopaedic Implants

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02566694
Enrollment
200
Registered
2015-10-02
Start date
2015-03-31
Completion date
2020-03-31
Last updated
2017-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implants

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

Interventions

PROCEDUREImplant

orthopaedic implant

Sponsors

Massachusetts General Hospital
CollaboratorOTHER
Coxa, Hospital for Joint Replacement
CollaboratorOTHER
Royal National Orthopaedic Hospital NHS Trust
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
11 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Cause of failureAt time of failure which is likely to be an average of 5 years post operative

Countries

United Kingdom

Contacts

Primary ContactIva Hauptmannova, BSc
Iva.Hauptmannova@rnoh.nhs.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026