Comparing ceramic dual mobility inserts to standard polyethylene inserts in hip replacement surgery
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
This study is testing if new ceramic hip replacement inserts are safer and more effective than standard plastic inserts for people getting hip surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 1 site (Ústí nad Labem) |
| Trial ID | NCT05547984 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with primary coxarthrosis who are indicated for cementless total hip arthroplasty.
Not a fit: Patients with hip trauma, revision surgery, or other joint implants, as well as those with elevated metal ion levels or significant comorbidities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and reduced metal ion exposure for patients undergoing hip replacement surgery.
How similar studies have performed: While there have been studies on metal ion release from modular dual mobility systems, this trial's direct comparison with standard articulation hip implants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ústí nad Labem
- Masaryk Hospital — Ústí nad Labem, Czechia (Recruiting)
Study contacts
- Study coordinator: Lutz Dreyer, Dr.
- Email: info@aesculap.de
- Phone: +49746195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.