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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04585022
Recruitment Status : Terminated (High early failure rates and adverse reactions in similar devices)
First Posted : October 14, 2020
Last Update Posted : October 29, 2020
Sponsor:
Information provided by (Responsible Party):
Anders Troelsen, Hvidovre University Hospital

Tracking Information
First Submitted Date  ICMJE September 23, 2020
First Posted Date  ICMJE October 14, 2020
Last Update Posted Date October 29, 2020
Actual Study Start Date  ICMJE November 1, 2006
Actual Primary Completion Date January 11, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2020)
Metal ion concentrations in blood [ Time Frame: at 5 years follow up ]
Chromium and cobalt concentrations in whole blood
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2020)
  • Patient reported outcome measure 1 [ Time Frame: at 5 years follow up ]
    Harris Hip Score (0-100, higher values meaning better outcome)
  • Patient reported outcome measure 2 [ Time Frame: at 5 years follow up ]
    SF-36 (0-100, higher values meaning better outcome)
  • Implant survival [ Time Frame: at 5 years follow up ]
    Rate of revision
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
Both the care provider and patient were blinded until day of surgery. The laboratory analyzing blood metal concentrations were blinded to treatment allocation throughout the study.
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Hip
Intervention  ICMJE
  • Device: Magnum, Zimmer Biomet, Warsaw, IN
  • Device: Recap, Zimmer Biomet, Warsaw, IN
Study Arms  ICMJE
  • Active Comparator: Magnum
    A metal-on-metal large diameter head total hip arthroplasty
    Intervention: Device: Magnum, Zimmer Biomet, Warsaw, IN
  • Active Comparator: Recap
    A metal-on-metal hip resurfacing arthroplasty
    Intervention: Device: Recap, Zimmer Biomet, Warsaw, IN
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 10, 2020)
75
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 11, 2017
Actual Primary Completion Date January 11, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04585022
Other Study ID Numbers  ICMJE KF 01-309171
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No IPD are to be shared with other researchers.
Responsible Party Anders Troelsen, Hvidovre University Hospital
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anders Troelsen, MD Hvidovre University Hospital
PRS Account Hvidovre University Hospital
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP