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

Primary Purpose

Osteoarthritis, Hip

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnum, Zimmer Biomet, Warsaw, IN
Recap, Zimmer Biomet, Warsaw, IN
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Hip focused on measuring Metal ion concentration, Total hip arthroplasty, Hip resurfacing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Magnum

    Recap

    Arm Description

    A metal-on-metal large diameter head total hip arthroplasty

    A metal-on-metal hip resurfacing arthroplasty

    Outcomes

    Primary Outcome Measures

    Metal Ion Concentrations in Blood
    Chromium and cobalt concentrations in whole blood

    Secondary Outcome Measures

    Harris Hip Score
    Harris Hip Score (0-100, higher values meaning better outcome)
    SF-36
    Short Form 36 Health Survey Questionnaire (SF-36) (0-100, higher values meaning better outcome)
    Number of Patients Undergoing Revision
    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)

    Full Information

    First Posted
    September 23, 2020
    Last Updated
    March 2, 2023
    Sponsor
    Hvidovre University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04585022
    Brief Title
    Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Terminated
    Why Stopped
    High early failure rates and adverse reactions in similar devices
    Study Start Date
    November 1, 2006 (Actual)
    Primary Completion Date
    January 11, 2017 (Actual)
    Study Completion Date
    January 11, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hvidovre University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis, Hip
    Keywords
    Metal ion concentration, Total hip arthroplasty, Hip resurfacing

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes 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.
    Allocation
    Randomized
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Magnum
    Arm Type
    Active Comparator
    Arm Description
    A metal-on-metal large diameter head total hip arthroplasty
    Arm Title
    Recap
    Arm Type
    Active Comparator
    Arm Description
    A metal-on-metal hip resurfacing arthroplasty
    Intervention Type
    Device
    Intervention Name(s)
    Magnum, Zimmer Biomet, Warsaw, IN
    Intervention Type
    Device
    Intervention Name(s)
    Recap, Zimmer Biomet, Warsaw, IN
    Primary Outcome Measure Information:
    Title
    Metal Ion Concentrations in Blood
    Description
    Chromium and cobalt concentrations in whole blood
    Time Frame
    at 5 years follow up
    Secondary Outcome Measure Information:
    Title
    Harris Hip Score
    Description
    Harris Hip Score (0-100, higher values meaning better outcome)
    Time Frame
    at 5 years follow up
    Title
    SF-36
    Description
    Short Form 36 Health Survey Questionnaire (SF-36) (0-100, higher values meaning better outcome)
    Time Frame
    at 5 years follow up
    Title
    Number of Patients Undergoing Revision
    Description
    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)
    Time Frame
    at 5 years follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anders Troelsen, MD
    Organizational Affiliation
    Hvidovre University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    No IPD are to be shared with other researchers.
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    Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing

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