Comparing Articular Noise and Its Perception Between Two Different Types of Individualized Total Knee Arthroplasty

Launched by CLINIQUE TRENEL · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the sounds, like clicking or popping, that some patients might hear after having a total knee replacement surgery for osteoarthritis, a condition where the knee joint wears down causing pain and stiffness. The study will compare two different types of customized knee implants to see if one causes more noise than the other. Both types are designed to fit each patient’s knee shape and help restore knee function, but they have different ways of supporting the knee’s ligaments.

Adults aged 65 to 74 who are having their first knee replacement on one knee because of osteoarthritis might be eligible to join. To participate, patients need to have a healthy ligament in the back of their knee, no major knee deformities, and no prior knee surgeries on either leg (except minor arthroscopic procedures). Participants should also be able to communicate in French and agree to follow the study’s guidelines. During the trial, patients will receive one of the two types of customized knee implants, and researchers will ask them about any noises they hear from their new knee after surgery. This study has not started recruiting yet, but it aims to help improve knee replacement surgeries by understanding how implant design affects patient experience.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Adult patients:
• • receiving elective primary TKA as a treatment for osteoarthritis
• • with an intact and functional posterior cruciate ligament
• • with no previous knee surgery, on the ipsi- or contra-lateral knee
• • who signed the informed consent and are willing to comply with the protocol requirements based on the investigator's judgment.
• • affiliated with a social security scheme
• • with an ability to answer questionnaires and to communicate freely in French.
• Exclusion Criteria:
• Patients:
• • that underwent previous knee surgery, except arthroscopic surgery, on their ipsilateral knee
• • with coronal deformities \>20°
• • that are pregnant
• • any contraindication mentioned in the instructions for use of the medical devices under investigation
• • with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code
• • with other significant disease or disorder which, in the opinion of the investigating surgeon, may put the participant at risk because of participation in the study, or may influence the result of the study
• • who cannot comply with the protocol requirements based on the investigator's judgment.