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

1

Research Sites

N/A

Total Duration

On this page

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

Eligible

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.
Not Eligible

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.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate recovery period

Participants undergo total knee arthroplasty surgery using one of two types of knee implants.

1 surgical procedure and hospital stay

Post-operative Follow-up

Duration - Up to 2 years

Participants are monitored for articular noise, discomfort, and impact on quality of life after surgery.

Visits at 1 year and 2 years post-surgery

Trial Site Locations

Total: 1 location

1

St Marguerite clinic

Auxerre, France, 89000

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Research Team

S

Stéphane Van DRIESSCHE, MD

A

Aurélia Cassany

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Noise after total knee arthroplasty has limited effect on joint awareness and patient-reported clinical outcomes: retrospective study.

Hiroto Taniguchi, Masafumi Itoh, Nobuyuki Yoshimoto...

https://pubmed.ncbi.nlm.nih.gov/32085760