Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing

March 2, 2023 updated by: Anders Troelsen, Hvidovre University Hospital

Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing - A Randomized Controlled Trial With 5-years Follow up Including 75 Patients

The investigators aimed to investigate the possible differences in metal ion concentrations in patients following one of two types of metal-on-metal articulating hip prosthesis regarding chromium and cobalt concentration, radiological findings, patient reported outcome measures and rate of revision at 5-years follow up.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The metal-on-metal large-diameter-head (MoM-LDH) hip replacements increased in popularity during the start of the 21st century. Subsequently reports raised concerns regarding adverse reactions due to elevated chromium (Cr) and cobalt (Co) concentrations as well as high rates of other complications and revisions.

This was a single center parallel-group randomized controlled trial. The primary outcome was to compare Cr and Co concentrations at 5-years follow up following MoM-LDH total hip arthroplasty (MoM-LDH-THA) or MoM-LDH hip resurfacing (MoM-LDH-HR).

Secondary outcomes were radiological findings, patient reported outcome measures and revision rate at 5-years follow up.

The study was prematurely terminated in 2012 due to alerts and safety communications from the Danish national regulatory agency regarding early failure rates and high incidence of ARMD in patients with MoM hip implants [13]. At that time the study population consisted of 75 patients out of 200 planned for inclusion.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary or secondary hip osteoarthritis eligible for hip replacement surgery
  • Able to give informed consent
  • Able to complete follow up consultations

Exclusion Criteria:

  • Earlier or present infection of the hip
  • Severe systemic or metabolic disease leading to weakening of the bone
  • Severe congenital hip dysplasia
  • Osteoporosis and/or renal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Magnum
A metal-on-metal large diameter head total hip arthroplasty
Device: Magnum, Zimmer Biomet, Warsaw, IN
Active Comparator: Recap
A metal-on-metal hip resurfacing arthroplasty
Device: Recap, Zimmer Biomet, Warsaw, IN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metal Ion Concentrations in Blood
Time Frame: at 5 years follow up
Chromium and cobalt concentrations in whole blood
at 5 years follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris Hip Score
Time Frame: at 5 years follow up
Harris Hip Score (0-100, higher values meaning better outcome)
at 5 years follow up
SF-36
Time Frame: at 5 years follow up
Short Form 36 Health Survey Questionnaire (SF-36) (0-100, higher values meaning better outcome)
at 5 years follow up
Number of Patients Undergoing Revision
Time Frame: at 5 years follow up
Rate of revision during the follow-up period, calculated as number of revisions (numerator) out of the total number of patients starting the study (denominator)
at 5 years follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hvidovre University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2006

Primary Completion (Actual)

January 11, 2017

Study Completion (Actual)

January 11, 2017

Study Registration Dates

First Submitted

September 23, 2020

First Submitted That Met QC Criteria

October 10, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KF 01-309171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD are to be shared with other researchers.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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