What is this study studying for knee replacement patients?

This study is evaluating the presence and perception of noises like clicking or popping in patients after total knee replacement surgery. Researchers aim to compare two types of knee prostheses to understand how often these noises occur and their impact on patient comfort and satisfaction. The sponsor supporting this research is Elsan.

Who may be eligible for this knee replacement clinical trial?

Adults 18 years or older receiving their first total knee replacement may be eligible. Participants must be able to comply with study requirements and be affiliated with a social security scheme. People with prior knee surgery on the target knee or certain knee deformities may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this knee replacement clinical trial?

Study-related care, including the surgical procedure and all trial visits, is provided at no cost. However, personal travel expenses to attend study visits may vary and are not guaranteed to be covered. Participants can plan accordingly based on their location and resources.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06880497

Monocentric, Randomized Study Comparing Articular Noise and Its Perception Between Two Types of Total Knee Arthroplasty

Led by Elsan · Updated on 2026-03-04

170

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the presence and perception of articular noise, such as clicking or popping sounds, in patients who have undergone total knee replacement surgery. The study aims to compare the prevalence of these noises between two types of knee prostheses an ultra-congruent total knee prosthesis Score 2, Amplitude and a posterior-stabilized total knee prosthesis Anatomic, Amplitude. This is important because previous studies have shown mixed results regarding the association between noise and patient discomfort or satisfaction after knee replacement. The study involves two groups receiving different types of total knee arthroplasty TKA. One group will receive the Score II ultra-congruent mobile-bearing cemented prosthesis designed to prevent femoral condyle subluxation during knee movement. The other group will receive the Anatomic posterior-stabilized fixed-bearing cemented prosthesis, which has a cam and post mechanism to provide knee stability. Only the cemented versions of both prostheses will be used in this randomized trial. Participants will be followed for up to two years, with assessments at one and two years after surgery. Researchers will measure the prevalence of articular noise, characterize the noise by discomfort, type, and location, and evaluate its impact on quality of life. Patient-reported outcome scores will also be collected. The study will monitor participant compliance and outcomes to better understand how these prosthesis designs affect noise perception and patient satisfaction over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adult patients receiving a primary total knee arthroplasty
Signed informed consent
Patients affiliated to a social security scheme
Patients willing and able to comply with study protocol requirements based on the investigator's judgment.

You will not qualify if you...

History of knee surgery on the concerned/studied knee (except arthroscopic surgery)
Patients presenting coronal deformities > 20°, varus laxity > 10° and/or valgus laxity > 15°
Patients receiving revision total knee arthroplasty
Pregnancy or breast-feeding
Patients with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code
Unable to comply with study procedures, based on the investigator's judgment.

Research Team

Stéphane Van DRIESSCHE, MD

Aurélia Cassany

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