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NCT Number: NCT06880497

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).

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Key information

Conditions

Knee Osteoarthristis Knee Replacement Arthroplasty Knee Replacement, Total

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Marguerite clinic

Auxerre, 89000, France

Location status: Recruiting

Location contact

Stephane Van Driessche, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total knee arthroplasty

Procedure

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

Other names: knee surgery, knee replacement

Primary outcomes

  1. Prevalence of articular noise

    Time frame: 2 years

    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

Secondary outcomes

  1. Noise characterisation: Discomfort

    Time frame: 1 year and 2 years

    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)

  2. Noise characterisation: Type

    Time frame: 1 and 2 years

    Characterisation of the type of noise:

    Q4: What kind of noise do you hear of feel? (Clunk, crepitus, grinding, clicking, other)

  3. Noise characterisation: Location

    Time frame: 1 and 2 years

    Characterisation of the location of noise:

    Q5: What part of the knee is involved? (Patella, joint, both, other)

  4. Noise characterisation: impact on quality of life

    Time frame: 1 and 2 years

    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)?

  5. Patient reported outcome score

    Time frame: 1 and 2 years

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): worst, 96; best, 0

Other outcomes

  1. Forgotten joint

    Time frame: 1 and 2 years

    Forgotten Joint Score (FJS): worst, 0; best, 100

  2. Patient reported outcome score

    Time frame: 1 and 2 years

    Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): worst, 96; best, 0

  3. Knee mobility: Maximum flexion

    Time frame: 3 weeks, 3 months, 1 years and 2 years

    Clinical evaluation of knee mobility, using measurements of maximum flexion: degrees

  4. Knee mobility: flexion contracture

    Time frame: 3 weeks, 3 months, 1 years and 2 years

    Clinical evaluation of knee mobility, using measurements of flexion contracture (FC): degrees

  5. Knee mobility: Range of motion

    Time frame: 3 weeks, 3 months, 1 years and 2 years

    Clinical evaluation of knee mobility, using measurements of range of motion (ROM): degrees

  6. Joint pain

    Time frame: 3 weeks, 3 months, 1 year and 2 years

    Pain assessment using the numeric scale (0 to 10): 0, no pain; 10, excruciating pain.

  7. Patient satisfaction

    Time frame: 1 and 2 years

    Patient satisfaction assessed using a 5-point Likert scale (very satisfied, satisfied, neutral, dissatisfied, very dissatisfied).

  8. Patient quality of life

    Time frame: 1 and 2 years

    Patient QoL using the EQ-5D-5L questionnaire: 0, worst; 1, best.

  9. Adverse events

    Time frame: 0 to 2 years

    Analysis of adverse events: incidence, severity, and relationship to the medical device.

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélia Cassany

CONTACT

[email protected]

+33(0)638229411

Stéphane Van DRIESSCHE, MD

CONTACT

[email protected]

+33(0)637675746

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study title

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

Acronym: NATKA

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 17, 2025
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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