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

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

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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