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

Launched by AESCULAP AG · Sep 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new type of hip implant called a modular dual mobility insert, which is designed to provide better stability and movement for patients undergoing total hip replacement surgery. The trial compares this new insert, which has a special ceramic coating, to the standard type made from polyethylene. The goal is to see which option is better for patients with coxarthrosis, a common hip condition.

To participate in this study, you must be between 65 and 74 years old and have a specific type of hip problem that requires surgery. You should be in good overall health and able to give your consent to join the trial. Unfortunately, if you have certain conditions like severe obesity, ongoing cancer treatment, or have had previous hip trauma or surgeries, you won't be eligible. If you join the study, you will receive one of the two types of implants and will be monitored regularly to see how well it works for you. This trial is currently recruiting participants, and your involvement could help improve hip surgery outcomes for future patients.

Gender

ALL

Eligibility 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