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

RecruitingNAAges 18 Years - anyAllElsan
NCT06880497 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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,

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📋 Eligibility rules (as published)
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.
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What it tests

  • total knee arthroplasty
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Where

1 site
St Marguerite clinic
Auxerre, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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