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A Randomized Controlled Trial Comparing Modular Dual Mobility Inserts With Ceramic Multilayer Coating Versus Standard Polyethylene Inserts for Primary Total Hip Arthroplasty (THA) in a Cementless Acetabular Cup
A randomized controlled trial comparing modular dual mobility inserts with ceramic multilayer coating versus standard polyethylene inserts for primary THA in a cementless acetabular cup
The aim of this study is to show in a randomized controlled trial that cobalt and chromium ion serum levels are comparable to the metal ion levels in patients with standard articulation with metal head. The metal on polyethylene articulation is accepted as standard articulation since many decades, and which is currently in the Czech Republic the most used combination. Most studies which focused on the topic of metal ion release from modular dual mobility systems do not present results of a control group with standard articulation hip implants.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Masaryk Hospital
Ústí nad Labem, Czechia
Start Date
November 21, 2022
Primary Completion Date
September 1, 2027
Completion Date
August 1, 2028
Last Updated
December 16, 2025
100
ESTIMATED participants
Dual Mobility Cup
DEVICE
Standard Acetabular component
DEVICE
Lead Sponsor
Aesculap AG
Data Source & Attribution
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