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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Device: Magnum, Zimmer Biomet, Warsaw, IN
* Device: Recap, Zimmer Biomet, Warsaw, IN


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score | Harris Hip Score (0-100, higher values meaning better outcome) | at 5 years follow up | 
| SF-36 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metal ion concentration, Total hip arthroplasty, Hip resurfacing