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Recruiting Not applicable

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

NCT06880497 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Not applicable
Started
2025-12-24
Last updated
2026-03-04

Condition(s) studied

Knee OsteoarthristisKnee Replacement ArthroplastyKnee Replacement, Total

Investigational drug(s) / intervention(s)

total knee arthroplasty

total knee arthroplasty: Replacement of knee articulating surface for patients with end-stage osteoarthritis.

Study summary

Some patients complain of articular noise (such as clicking, snapping, cracking or popping) after a total knee replacement. Controversy remains about whether there is a correlation between articular noise and worse outcomes following a knee replacement. A study by Nam et al. on 1540 patients revealed an association between noise and residual symptoms 30 days after they received a total knee replacement. Conversely, a study by Kuriyama et al. on 60 patients revealed no correlation between noise and patient satisfaction after 1 year of receiving a total knee replacement. The incidence of noise following a knee replacement has rarely been studied as a primary outcome. Like pain, it could be considered an important patient-reported outcome to assess patient satisfaction. The study aims to compare the prevalence of patient-perceived noise of an ultra-congruent total knee prosthesis (Score 2, Amplitude) versus a posterior-stabilized total knee prosthesis (Anatomic, Amplitude).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients receiving a primary TKA * 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. Exclusion Criteria: * 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 TKA * 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.

Primary outcome measure(s)

  • Prevalence of articular noise — 2 years
    The primary outcome is the prevalence of patients with articular noise at 2 years, evaluated by the Investigator during the follow-up visit through clinical examination and using the following question (Q1): Q1: Do you hear noise? Never, rarely, sometimes, often, extremely often

Trial sites (1)

FacilityCityRegionStatus
St Marguerite clinic Auxerre France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06880497 on ClinicalTrials.gov ↗ ← All trials in France