Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing
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|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 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Hip||Device: Magnum, Zimmer Biomet, Warsaw, IN Device: Recap, Zimmer Biomet, Warsaw, IN||Not Applicable|
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 . At that time the study population consisted of 75 patients out of 200 planned for inclusion.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|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.|
|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, 2012|
|Actual Primary Completion Date :||January 11, 2017|
|Actual Study Completion Date :||January 11, 2017|
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
- Metal ion concentrations in blood [ Time Frame: at 5 years follow up ]Chromium and cobalt concentrations in whole blood
- 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
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
|Principal Investigator:||Anders Troelsen, MD||Hvidovre University Hospital|