Analysis of Specimens From Patients With Orthopaedic Implants

NCT02566694 — Unknown, 200 participants, Royal National Orthopaedic Hospital NHS Trust

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Registry	NCT02566694
Status	Unknown
Study type	Observational
Enrollment	200 (Estimated)
Sponsor	Royal National Orthopaedic Hospital NHS Trust (Other); collaborators: Massachusetts General Hospital, Coxa, Hospital for Joint Replacement
Conditions	Implants
Interventions	Implant (Procedure)
Dates	start 2015-03-01, primary completion 2018-03-01 (estimated), completion 2020-03-01 (estimated), first posted 2015-10-02, last updated 2017-04-12
Locations	1 site in United Kingdom

-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.

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+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

+Arms and interventions

Arm	Type	Interventions	Description
Failed implants		Procedure: 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		Procedure: Implant	We will compare findings with different types of orthopaedic implants and categories of failure mode.

Implant (Procedure): orthopaedic implant

+Outcome measures

Primary outcomes

Cause of failure [At time of failure which is likely to be an average of 5 years post operative]

+Eligibility

Sex: All, ages: 11 Years to 70 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Royal National Orthopaedic Hospital	Stanmore, London	United Kingdom	Recruiting

+Investigators

Alister Hart, FRCSG(Orth), Principal investigator, RNOH