Comparing ceramic dual mobility inserts to standard polyethylene inserts in hip replacement surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a randomized controlled trial that aims to compare the effectiveness of modular dual mobility inserts with a ceramic multilayer coating against standard polyethylene inserts in patients undergoing primary total hip arthroplasty (THA). The study focuses on measuring cobalt and chromium ion serum levels to determine if they are comparable to those found in patients using standard metal-on-polyethylene articulations. The trial is designed to provide insights into the safety and efficacy of dual mobility systems in hip replacements, which have not been extensively compared to traditional methods in previous studies.

Why it matters

Who can join: the full rules

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's running

• Masaryk Hospital
  Ústí nad Labem, Czechia Recruiting

Study contacts

• Study coordinator: Lutz Dreyer, Dr.
• Email: info@aesculap.de
• Phone: +49746195

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.