Analysis of Specimens From Patients With Orthopaedic Implants

Implants Clinical Trial

Official title:

Analysis of Specimens From Patients With Orthopaedic Implants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02566694
• Other study ID #: RNOH LIRC
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2015
• Last updated: April 11, 2017
• Start date: March 2015
• Est. completion date: March 2020

Study information

• Verified date: April 2017
• Source: Royal National Orthopaedic Hospital NHS Trust
• Contact: Iva Hauptmannova, BSc
• Email: Iva.Hauptmannova[@]rnoh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2020
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Implants

Intervention

Procedure:
• Implant
orthopaedic implant

Locations

Country	Name	City	State
United Kingdom	Royal National Orthopaedic Hospital	Stanmore	London

Sponsors (3)

Lead Sponsor	Collaborator
Royal National Orthopaedic Hospital NHS Trust	Coxa, Hospital for Joint Replacement, Massachusetts General Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cause of failure		At time of failure which is likely to be an average of 5 years post operative