RecruitingNot ApplicableNCT06880497

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

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


Sponsor

Elsan

Enrollment

170 participants

Start Date

Dec 24, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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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Interventions

PROCEDUREtotal knee arthroplasty

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


Locations(1)

St Marguerite clinic

Auxerre, France

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NCT06880497


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