Metal Ions in Ceramic on Metal Total Hip Arthroplasty

NCT01437124 | Completed Results DMC

• 1 other identifier: 960558216
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to measure the blood levels of certain metals in a group of patients all of whom have had a ceramic on metal total hip replacement. This new bearing surface (joint) is relatively new and the investigators are currently following up the largest cohort in the world. Clinical results are currently excellent at 2 years in all patients, however the investigators are mindful of the lessons learned from the high failure rate of several designs of metal on metal hip replacements as well as several in vitro reports and one in vivo case report of elevated metal levels in this particular implant. The investigators feel it is important to measure the metal ion levels in our group to ascertain and compare these with reference standards. Once performed the investigators can relate ion levels to function and x ray changes and provide useful longterm data to the patients and the wider medical community as to whether this bearing surface is safe in the long term or whether it's use should be abandoned. This is useful as there are numerous groups implanting this device in the UK and in addition it has just been awarded FDA approval in the USA - its use is likely to flourish.

Conditions

Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis; Developmental Dysplasia of the Hip

Outcome Measures

Primary Outcomes (1)

• Cobalt Chromium Levels

  Serum cobalt chromium levels post THR

  2 years post THR

Secondary Outcomes (1)

• Chromosomal Abnormality

  2 years post THR

Study Arms (1)

Ceramic on metal THA

Those who have received a ceramic on metal total hip replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Those who have received a ceramic on metal total hip arthroplasty

You may qualify if:

• Over 18 years of age
• Complete history and physical examination
• Previously performed ceramic on metal total hip replacement
• An understanding of the purpose of the study and signed consent form

You may not qualify if:

• Hip arthroplasty other than ceramic on metal bearing
• Mentally infirm / incapacitated
• Incomplete history or physical examination
• Unwillingness to participate in the study

Sponsors & Collaborators

• Hussain Kazi: lead

Study Sites (1)

Wirral University Teaching Hospitals NHS Foundation Trust

Metropolitan Borough of Wirral, Merseyside, CH49 5PE, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Arthritis, Rheumatoid; Developmental Dysplasia of the Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Hip Dislocation; Joint Dislocations; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Hussain Kazi
• Organization: Wirral NHS Trust

hussainkazi@nhs.net

0151 678 6111

Study Officials

• Fintan A Carroll, MBBS, FRCS

  Consultant Orthopaedic Surgeon

  STUDY DIRECTOR

• Hussain A Kazi, MBChB,FRCS

  Specialist Registrar, Trauma & Orthopaedics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist Registrar, Trauma and Orthopaedics

Study Record Dates

• First Submitted: September 16, 2011
• First Posted: September 20, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 6, 2016
• Results First Posted: June 6, 2016

Record last verified: 2016-04

Locations

GB (1)