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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

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Device: Magnum, Zimmer Biomet, Warsaw, IN Device: Recap, Zimmer Biomet, Warsaw, IN Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
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
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
Actual Study Start Date : November 1, 2006
Actual Primary Completion Date : January 11, 2017
Actual Study Completion Date : January 11, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Cimetidine

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



Primary Outcome Measures :
  1. Metal ion concentrations in blood [ Time Frame: at 5 years follow up ]
    Chromium and cobalt concentrations in whole blood


Secondary Outcome Measures :
  1. Patient reported outcome measure 1 [ Time Frame: at 5 years follow up ]
    Harris Hip Score (0-100, higher values meaning better outcome)

  2. Patient reported outcome measure 2 [ Time Frame: at 5 years follow up ]
    SF-36 (0-100, higher values meaning better outcome)

  3. Implant survival [ Time Frame: at 5 years follow up ]
    Rate of revision



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04585022


Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Principal Investigator: Anders Troelsen, MD Hvidovre University Hospital
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Responsible Party: Anders Troelsen, MD, PhD, dr.med., Professor, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT04585022    
Other Study ID Numbers: KF 01-309171
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD are to be shared with other researchers.
Keywords provided by Anders Troelsen, Hvidovre University Hospital:
Metal ion concentration
Total hip arthroplasty
Hip resurfacing
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Cimetidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors