Knee OsteoarthristisNATKANCT06880497
Comparing Articular Noise and Its Perception Between Two Different Types of Total Knee Arthroplasty
A study testing total knee arthroplasty in people with Knee Osteoarthristis and Knee Replacement Arthroplasty, run by Elsan at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthristis, Knee Replacement Arthroplasty, Knee Replacement, Total
- What is being tested?
- total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 24 Dec 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
St Marguerite clinic
Auxerre, 89000
Stephane Van Driessche, MD
About this study
Official title: 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).
- Being tested
- total knee arthroplasty
- Keywords
- Noise, Articular noise, Total Knee Arthroplasty, TKA, Total Knee Replacement, TKR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee arthroplastyProcedure or surgery
Also called knee surgery, knee replacement
Replacement of knee articulating surface for patients with end-stage osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| UC TKA | Active comparator | 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. Receives: Procedure: total knee arthroplasty |
| PS TKA | Active comparator | 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. Receives: Procedure: total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (5)
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)
Measured: 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)
Measured: 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)
Measured: 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)?
Measured: 1 and 2 years
Patient reported outcome score
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): worst, 96; best, 0
Measured: 1 and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start24 Dec 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, monocentric, comparative, 1:1 randomized, single-blinded study evaluating the prevalence of articular noise following primary TKA using UC versus PS implants.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880497
- Sponsor's protocol ID
- 2024-02452-45
- Acronym
- NATKA
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon a reasonable request, the authors will consider sharing anonymised data while adhering to French and European laws.
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.
PubMed 32085760Nam 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.
PubMed 26762299
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric, Randomized Study, Comparing Articular Noise and Its Perception Between Two Different Types of Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06880497
- Acronym / sponsor ID
- NATKA / 2024-02452-45
- Keywords
- Noise, Articular noise, Total Knee Arthroplasty, TKA, Total Knee Replacement, TKR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 24 Dec 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, monocentric, comparative, 1:1 randomized, single-blinded study evaluating the prevalence of articular noise following primary TKA using UC versus PS implants.
| Arm | Type | Receives |
|---|---|---|
| UC TKA | Active comparator | Procedure: total knee arthroplastyThe 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. |
| PS TKA | Active comparator | Procedure: total knee arthroplastyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total knee arthroplastyAlso: knee surgery, knee replacementReplacement of knee articulating surface for patients with end-stage osteoarthritis. | Procedure or surgery | PS TKA, UC TKA |
Primary outcome
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
5 secondary outcomes
Noise characterisation: Discomfort
Time frame: 1 year and 2 years
Noise characterisation: Type
Time frame: 1 and 2 years
Noise characterisation: Location
Time frame: 1 and 2 years
Noise characterisation: impact on quality of life
Time frame: 1 and 2 years
Patient reported outcome score
Time frame: 1 and 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Results publication: PubMed 32085760Taniguchi 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.
- Results publication: PubMed 26762299Nam 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.
- Individual participant dataSharing planned: Undecided. Upon a reasonable request, the authors will consider sharing anonymised data while adhering to French and European laws.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total knee arthroplasty in people with Knee Osteoarthristis and Knee Replacement Arthroplasty, run by Elsan at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Van DRIESSCHE, MD (+33(0)637675746, svandri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of articular noise (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06880497, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.