Immunology of Failing Metal-on-Metal Hip Replacement

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by University of East Anglia
Sponsor:
Collaborator:
Depuy, Inc.
Information provided by (Responsible Party):
University of East Anglia
ClinicalTrials.gov Identifier:
NCT01517737
First received: January 20, 2012
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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.


Condition
Infection of Total Hip Joint Prosthesis
Implants

Study Type: Observational
Official Title: Immune Cell Involvement in the Tissue Response to Metallosis in Patients With Failed Metal-on-metal Hip Replacements

Resource links provided by NLM:


Further study details as provided by University of East Anglia:

Biospecimen Retention:   Samples With DNA

blood from all patients; joint fluid, soft tissue and bone on operated patients


Estimated Enrollment: 105
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The Ultima TPS patients are all identified and regularly followed up. Other patients will be identified from planned operating lists and waiting lists. This will be carried out by the research team.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517737

Contacts
Contact: Simon Donell, M.D. 01603287531 simon.donell@nnuh.nhs.uk

Locations
United Kingdom
Norfolk and Norwich University Hospital NHS Trust Recruiting
Norwich, Norfolk, United Kingdom, NR4 7UY
Contact: Simon Donell, M.D.    01603287531    simon.donell@nnuh.nhs.uk   
Principal Investigator: Pinar Court         
Norfolk and Norwich University Hospital Recruiting
Norwich, Norfolk, United Kingdom, NR4 7UY
Principal Investigator: Pinar Court         
Sponsors and Collaborators
University of East Anglia
Depuy, Inc.
Investigators
Principal Investigator: Pinar Court University of East Anglia
  More Information

No publications provided

Responsible Party: University of East Anglia
ClinicalTrials.gov Identifier: NCT01517737     History of Changes
Other Study ID Numbers: 2011 Orth 04S (68-06-11), IIS2010015
Study First Received: January 20, 2012
Last Updated: February 8, 2012
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on August 19, 2014