Analysis of Specimens From Patients With Orthopaedic Implants

Royal National Orthopaedic Hospital NHS Trust

Status: Unknown

Conditions: Implants

Treatments: Procedure: Implant

Study type: Observational

Funder types: Other

Identifiers

NCT02566694

RNOH LIRC

Details and patient eligibility

About

The investigators aim to determine the cause of failure of orthopaedic implants using multi-disciplinary analysis of data from patients who have undergone revision.

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 11 to 70 years old

Volunteers: 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

Trial design

200 participants in 2 patient groups

Failed implants

Description:

All patients undergoing revision of an orthopaedic implant (previously this was limited to metal hips but this has now expanded to other orthopaedic implants)

Treatment:

Procedure: Implant

Controls with different failure modes

Description:

We will compare findings with different types of orthopaedic implants and categories of failure mode.

Treatment:

Procedure: Implant