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

Hvidovre University Hospital

Status: Terminated

Conditions: Osteoarthritis, Hip

Treatments: Device: Magnum, Zimmer Biomet, Warsaw, IN; Device: Recap, Zimmer Biomet, Warsaw, IN

Study type: Interventional

Funder types: Other

Identifiers

NCT04585022

KF 01-309171

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 2 patient groups

Magnum

Active Comparator group

Description:

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

Treatment:

Device: Magnum, Zimmer Biomet, Warsaw, IN

Recap

Active Comparator group

Description:

A metal-on-metal hip resurfacing arthroplasty

Treatment:

Device: Recap, Zimmer Biomet, Warsaw, IN