Ceramic Modular Dual Mobility in Primary Total Hip Arthroplasty (THA)
Recruiting · NCT05547984 · Interventional (participants receive a specific treatment) · Lead sponsor: Aesculap AG
View the official record on ClinicalTrials.gov →Interventions studied
Dual Mobility CupStandard Acetabular component
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Primary coxarthrosis patients indicated for cementless total hip arthroplasty
- Written informed patient consent
Exclusion criteria
- Hip trauma or revision surgery
- Rheumatoid or neurologic disease
- BMI \>35
- Ongoing oncologic therapy
- Preoperatively elevated Co or Cr serum levels \>1.0 µg/L
- Patients with other joint implants, or anticipated need for another joint replacement surgery within the study period
- Acetabular cup size \<52 expected
- Patients not able to mentally or physically comply with the study demands and follow-up visits
- Patients \<18 years at surgery
- Pregnancy
Where it is running
1 location listed.
- Masaryk Hospital - Ústí nad Labem, Czechia