NCT05547984

Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA)

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Coxarthrosis; Primary

Interventions

Type	Name	Description
DEVICE	Dual Mobility Cup	Total hip arthroplasty (THA) is a successful and established therapy for coxarthrosis, rheumatic arthritis, hip fractures and femoral head necrosis. The acetabular implant for this arm is the Dual Mobility cup
DEVICE	Standard Acetabular component	Total hip arthroplasty (THA) is a successful and established therapy for coxarthrosis, rheumatic arthritis, hip fractures and femoral head necrosis. The acetabular implant for this arm is the standard device with polyethylene + vitamin E inlay and metal head

Timeline

• Start date: 2022-11-21
• Primary completion: 2027-09-01
• Completion: 2028-08-01
• First posted: 2022-09-21
• Last updated: 2025-12-16

Locations

1 site across 1 country: Czechia