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

Not Applicable

Terminated

• Conditions: Osteoarthritis, Hip
• Interventions: Device: Magnum, Zimmer Biomet, Warsaw, IN; Device: Recap, Zimmer Biomet, Warsaw, IN

• Registration Number: NCT04585022
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-11-01
• Primary Completion: 2017-01-11
• Study Completion: 2017-01-11
• Study First Submitted: 2020-09-23
• Study First Submitted QC: 2020-10-10
• Study First Posted: 2020-10-14
• Results First Submitted: 2021-09-30
• Status Verified: 2023-03
• Results First Submitted QC: 2023-03-02
• Last Update Submitted: 2023-03-02
• Results First Posted: 2023-03-03
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Primary or secondary hip osteoarthritis eligible for hip replacement surgery
• Able to give informed consent
• Able to complete follow up consultations

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnum	Magnum, Zimmer Biomet, Warsaw, IN	A metal-on-metal large diameter head total hip arthroplasty
Recap	Recap, Zimmer Biomet, Warsaw, IN	A metal-on-metal hip resurfacing arthroplasty

Primary Outcome Measures

Name	Time	Method
Metal Ion Concentrations in Blood	at 5 years follow up	Chromium and cobalt concentrations in whole blood

Secondary Outcome Measures

Name	Time	Method
SF-36	at 5 years follow up	Short Form 36 Health Survey Questionnaire (SF-36) (0-100, higher values meaning better outcome)
Number of Patients Undergoing Revision	at 5 years follow up	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)
Harris Hip Score	at 5 years follow up	Harris Hip Score (0-100, higher values meaning better outcome)