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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Knee Replacement Arthroplasty; Knee Replacement, Total; Knee Osteoarthristis
• Intervention / Treatment: Procedure: total knee arthroplasty

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stéphane Van DRIESSCHE, MD; Phone Number: +33(0)637675746; Email: svandri@gmail.com
• Study Contact Backup: Name: Aurélia Cassany; Phone Number: +33(0)638229411; Email: cassany@elsan.care

Study Locations

• France
  • Auxerre, France, 89000
    • Recruiting
    • St Marguerite clinic
    • Contact: Stephane Van Driessche, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: UC TKA; 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.	Procedure: total knee arthroplasty; Replacement of knee articulating surface for patients with end-stage osteoarthritis.; Other Names: knee replacement; knee surgery
Active Comparator: PS TKA; 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.	Procedure: total knee arthroplasty; Replacement of knee articulating surface for patients with end-stage osteoarthritis.; Other Names: knee replacement; knee surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of articular noise	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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noise characterisation: Discomfort	Characterisation of discomfort due to noise Q2: Do you feel noise? (Never, rarely, sometimes, often, extremely often) Q3: Is the noise a concern, causing discomfort? (Never, rarely, sometimes, often, extremely often)	1 year and 2 years
Noise characterisation: Type	Characterisation of the type of noise: Q4: What kind of noise do you hear of feel? (Clunk, crepitus, grinding, clicking, other)	1 and 2 years
Noise characterisation: Location	Characterisation of the location of noise: Q5: What part of the knee is involved? (Patella, joint, both, other)	1 and 2 years
Noise characterisation: impact on quality of life	Characterisation of impact on quality of life: Q6: What is the impact of the noise on your quality of life, on a scale from 0 (none) to 10 (severe)?	1 and 2 years
Patient reported outcome score	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): worst, 96; best, 0	1 and 2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcome score	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): worst, 96; best, 0	1 and 2 years
Forgotten joint	Forgotten Joint Score (FJS): worst, 0; best, 100	1 and 2 years
Knee mobility: Maximum flexion	Clinical evaluation of knee mobility, using measurements of maximum flexion: degrees	3 weeks, 3 months, 1 years and 2 years
Knee mobility: flexion contracture	Clinical evaluation of knee mobility, using measurements of flexion contracture (FC): degrees	3 weeks, 3 months, 1 years and 2 years
Knee mobility: Range of motion	Clinical evaluation of knee mobility, using measurements of range of motion (ROM): degrees	3 weeks, 3 months, 1 years and 2 years
Joint pain	Pain assessment using the numeric scale (0 to 10): 0, no pain; 10, excruciating pain.	3 weeks, 3 months, 1 year and 2 years
Patient satisfaction	Patient satisfaction assessed using a 5-point Likert scale (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied).	1 and 2 years
Patient quality of life	Patient QoL using the EQ-5D-5L questionnaire: 0, worst; 1, best.	1 and 2 years
Adverse events	Analysis of adverse events: incidence, severity, and relationship to the medical device.	0 to 2 years

Collaborators and Investigators

• Sponsor: Elsan

Publications and helpful links

General Publications

• Taniguchi H, Itoh M, Yoshimoto N, Itou J, Kuwashima U, Okazaki K. Noise after total knee arthroplasty has limited effect on joint awareness and patient-reported clinical outcomes: retrospective study. BMC Musculoskelet Disord. 2020 Feb 21;21(1):115. doi: 10.1186/s12891-020-3134-7.
• Nam D, Barrack T, Nunley RM, Barrack RL. What Is the Frequency of Noise Generation in Modern Knee Arthroplasty and Is It Associated With Residual Symptoms? Clin Orthop Relat Res. 2017 Jan;475(1):83-90. doi: 10.1007/s11999-016-4701-y.

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 4, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 17, 2025

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Total Knee Replacement; TKA; TKR; Noise; Articular noise
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation; Arthroplasty, Replacement, Knee
• Other Study ID Numbers: 2024-02452-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Upon a reasonable request, the authors will consider sharing anonymised data while adhering to French and European laws.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No