Immunology of Failing Metal-on-Metal Hip Replacement

Implants Clinical Trial

Official title:

Immune Cell Involvement in the Tissue Response to Metallosis in Patients With Failed Metal-on-metal Hip Replacements

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01517737
• Other study ID #: 2011 Orth 04S (68-06-11)
• Secondary ID: IIS2010015
• Status: Recruiting
• Phase: N/A
• First received: January 20, 2012
• Last updated: February 8, 2012
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: February 2012
• Source: University of East Anglia
• Contact: Simon Donell, M.D.
• Phone: 01603287531
• Email: simon.donell[@]nnuh.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

Metal-on-metal total hip replacement (MoM THR) has been targeted at younger patients with anticipated long-term survival since the bearing surfaces wear less than the traditional metal-on-plastic (MoP) replacements. However, the production of metal ions as a result of the wear is a concern because of the possible toxicity to cells. In Norwich England a number of different metal-on-metal implants have been trialed of which one, the Ultima TPS, has had very poor results. A total of 545 patients have had 652 MoM THRs with the Ultima TPS of whom more than 20% have now been revised. There is an ongoing MHRA program to screen for problems using MRI scans with a technique developed in Norwich. Investigations so far show massive corrosion in the implants with a catastrophic immune response causing death of cells. This may include death of bone leading to fracture. In a third of patients revised there has been pain but normal plain X-rays. In some patients without pain who have been screened there are abnormal changes on an MRI scan. We wish to investigate the immune cells in patients to find out why this has happened. The study will include patients coming for a new hip to act as a comparator, as well as those with a MoM THR and patients being revised with MoM THRs, and MoP THRs. We shall also investigate patients with other MoM THRs opportunistically.

Description:

To characterize dendritic cell (DC) populations in MoM THR patients. Dendritic cells are cells that migrate from the circulating blood into tissues and mop up foreign material such as viruses with their abnormal surface makers (antigens)and metal debris, activating specialist white blood cells (such as T cells) that kill viruses and remove abnormal material.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who have undergone Ultima TPS THRs in Norwich

• Patients with a MoP THR under going revision.

• Patients undergoing primary hip replacement with osteoarthritis

• Patients with other MoM THRs undergoing revision

Exclusion Criteria:

• Patients undergoing primary THR with rheumatoid arthritis or other inflammatory arthritides, or secondary to infection

Study Design

N/A

Related Conditions & MeSH terms

• Implants
• Infection of Total Hip Joint Prosthesis

Locations

Country	Name	City	State
United Kingdom	Norfolk and Norwich University Hospital	Norwich	Norfolk
United Kingdom	Norfolk and Norwich University Hospital NHS Trust	Norwich	Norfolk

Sponsors (2)

Lead Sponsor	Collaborator
University of East Anglia	Depuy, Inc.

Country where clinical trial is conducted

United Kingdom,