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

E

Elsan

Status

Not yet enrolling

Conditions

Knee Replacement Arthroplasty
Knee Replacement, Total
Knee Osteoarthristis

Treatments

Procedure: total knee arthroplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT06880497
2024-02452-45

Details and patient eligibility

About

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).

Enrollment

170 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

170 participants in 2 patient groups

UC TKA
Active Comparator group
Description:
The Score II® is a primary cruciate-sacrificing TKA, with a single-radius femoral component that articulates in an ultra-congruent (UC) mobile-bearing tibial insert. The mobile-bearing tibial insert has high anterior and posterior borders to avoid anterior subluxation of the femoral condyles during knee flexion and a concave articular surface with a radius of curvature that matches that of the femoral component in the sagittal plane to ensure high congruence. The Score II® UC TKA comprises eight sizes and offers the choice of using a cemented or uncemented version. In this study, only the cemented version will be used.
Treatment:
Procedure: total knee arthroplasty
PS TKA
Active Comparator group
Description:
The Anatomic® is a primary PS TKA with a fixed-bearing polyethylene insert. The femoral component has a cam design that engages on a tibial post to provide anterior-posterior stability during flexion. The Anatomic® PS TKA comprises nine cemented sizes. In this study, only the cemented version will be used. The Anatomic® PS TKA comprises nine cemented sizes.
Treatment:
Procedure: total knee arthroplasty

Trial contacts and locations

0

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Central trial contact

Aurélia Cassany; Stéphane Van DRIESSCHE, MD

Data sourced from clinicaltrials.gov

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