OsteoarthritisANIKANCT07030049
Comparing Articular Noise and Its Perception Between Two Different Types of Individualized Total Knee Arthroplasty
A study testing Postero-stabilized total knee replacement for knee osteoarthritis and Cruciate-retaining total knee replacement for knee osteoarthritis in people with Osteoarthritis and TKA, run by Clinique Trenel.
Trial summary
Knee osteoarthritis is a degenerative joint disorder leading to pain and limited movement. Total knee arthroplasty (TKA) has transformed the treatment of knee osteoarthritis, resulting in long-term outcomes that enhance the quality of life for patients. Some individuals report experiencing noise after undergoing TKA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, TKA
- What is being tested?
- Postero-stabilized total knee replacement for knee osteoarthritis and Cruciate-retaining total knee replacement for knee osteoarthritis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2025to 30 Sep 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 elective primary TKA as a treatment for osteoarthritis
- with an intact and functional posterior cruciate ligament
- with no previous knee surgery, on the ipsi- or contra-lateral knee
- who signed the informed consent and are willing to comply with the protocol requirements based on the investigator's judgment.
- affiliated with a social security scheme
- with an ability to answer questionnaires and to communicate freely in French.
Who cannot join
- Patients:
- that underwent previous knee surgery, except arthroscopic surgery, on their ipsilateral knee
- with coronal deformities >20°
- that are pregnant
- any contraindication mentioned in the instructions for use of the medical devices under investigation
- with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code
- with other significant disease or disorder which, in the opinion of the investigating surgeon, may put the participant at risk because of participation in the study, or may influence the result of the study
- who cannot comply with the protocol requirements based on the investigator's judgment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Monocentric, Randomized Study, Comparing Articular Noise and Its Perception Between Two Different Types of Individualized Total Knee Arthroplasty
Knee osteoarthritis is a degenerative joint disorder leading to pain and limited movement. Total knee arthroplasty (TKA) has transformed the treatment of knee osteoarthritis, resulting in long-term outcomes that enhance the quality of life for patients. Some individuals report experiencing noise after undergoing TKA. However, there are few randomized controlled trials that assess postoperative noise following the procedure. Additionally, no research has been conducted on individualized TKA, which involves custom-made prostheses tailored to a patient's knee shape. This study aimed to compare the incidence of noise reported by patients who undergo a primary individualized TKA using either cruciate-retaining or posterior-stabilized designs.
Read the detailed description
Articular noise is common after total knee arthroplasty (TKA), yet there is ongoing debate regarding its effect on postoperative outcomes, joint awareness and patient satisfaction. A comparative study on articular noise in 50 patients undergoing bilateral TKA using two different prosthesis designs reported that an ultra-congruent design generated less noise than a posterior-stabilized design (18% compared with 38%; p= 0.026), but there were no differences in patient preference, satisfaction, or Forgotten Joint Score (FJS) at two-year follow-up. A retrospective analysis of 160 robot-assisted and 320 conventional TKA revealed no difference in the prevalence of articular noise (40.7% vs 38.1%; p=0.647), but patients who complained of noise had lower FJS (45.5 vs 66.1; p<0.001) and lower Knee Injury and Osteoarthritis Score Joint Replacement (KOOS-JR) scores (72.0 vs 81.4; p<0.001) at one-year follow-up.
Recent advancements have shifted medicine from standardised approaches to personalised or precision medicine, tailoring treatments and decisions for individual patients based on their specific responses and risk factors. Individualized TKA adapts features to align with pre-arthritic anatomy and restore native movement, often utilising various tools. Recent studies on individualized TKA have demonstrated promising outcomes regarding personalised coronal alignment targets, correction of extra-articular deformities, intra-operative workflow, accommodation of the third compartment, and patient satisfaction rates.
This study will compare a posterior-stabilised (PS) and a cruciate-retaining (CR) individualized TKA implant. The PS implant is selected for patients with a damaged or a non-functional posterior cruciate ligament. In this case, the ligament is removed and substituted with a post-cam mechanism that aids femoral rollback during knee flexion and avoids anterior femoral subluxation. In contrast, the CR implant design can be selected for patients with an intact and functional posterior cruciate ligament. In this case, the ligament is retained, allowing it to guide femoral rollback and prevent anterior subluxation.
- Conditions
- Osteoarthritis, TKA
- Being tested
- Postero-stabilized total knee replacement for knee osteoarthritis, Cruciate-retaining total knee replacement for knee osteoarthritis
- Keywords
- osteoarthritis, TKA, articular noise
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postero-stabilized total knee replacement for knee osteoarthritisDevice
Total knee arthroplasty in which the osteoarthritic knee is replaced with a postero-stabilized total knee replacement. The postero-stabilized TKA consists of a femoral component with a build-in cam mechanism and a tibial component with a post-mechanism.
Cruciate-retaining total knee replacement for knee osteoarthritisDevice
Total knee arthroplasty in which the osteoarthritic knee is replaced with a cruciate-retaining total knee replacement. The cruciate-retaining TKA consists of a femoral component and a tibial component that leaves the posterior cruciate ligament intact.
| Study group | Role | What they receive |
|---|---|---|
| PS-group | Experimental | Individualized PS TKA Receives: Device: Postero-stabilized total knee replacement for knee osteoarthritis |
| CR-group | Active comparator | Individualized CR TKA Receives: Device: Cruciate-retaining total knee replacement for knee osteoarthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Do you hear noise originating from your knee?
The surgeon will ask the blind participant whether they hear articular noise originating from their knee two years after TKA.
Measured: 2 years
Secondary outcomes (5)
Do you feel noise?
The surgeon will ask the blind participant whether they feel articular noise originating from their knee.
Measured: 1 & 2 years
Is the noise a concern or causing discomfort?
The surgeon will ask the blind participant whether the articular noise originating from their knee is a concern or causing discomfort.
Measured: 1 & 2 years
What kind of noise do you hear of feel?
The surgeon will ask the blind participant what kind articular noise originating from their knee (clunk, crepitus, grinding, clicking, other).
Measured: 1 & 2 years
What part of the knee is involved?
The surgeon will ask the blind participant to identify which part of the knee is involved if they hear articular noise originating from their knee.
Measured: 1 & 2 years
What is the impact of the noise on your quality of life, on a scale from 0 (none) to 10 (severe)?
The surgeon will ask the blind participant how their quality of life is affected by the articular noise originating from their knee.
Measured: 1 & 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised controlled single-blinded monocentre trial in a superiority framework with a 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Trenel
- Sponsor type
- University, hospital or other
- Collaborators
- ProSurg
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030049
- Sponsor's protocol ID
- 25.01072.000461
- Other IDs
- 2025-A00647-42
- Acronym
- ANIKA
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It goes against GDPR and other EU regulations
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. 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 Individualized Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07030049
- Acronym / sponsor ID
- ANIKA / 25.01072.000461
- Conditions
- Osteoarthritis, TKA
- Keywords
- osteoarthritis, TKA, articular noise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Clinique TrenelUniversity, hospital or other
- Collaborators
- ProSurg
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 19 Jun 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.
Knee osteoarthritis is a degenerative joint disorder leading to pain and limited movement. Total knee arthroplasty (TKA) has transformed the treatment of knee osteoarthritis, resulting in long-term outcomes that enhance the quality of life for patients. Some individuals report experiencing noise after undergoing TKA. However, there are few randomized controlled trials that assess postoperative noise following the procedure. Additionally, no research has been conducted on individualized TKA, which involves custom-made prostheses tailored to a patient's knee shape. This study aimed to compare the incidence of noise reported by patients who undergo a primary individualized TKA using either cruciate-retaining or posterior-stabilized designs.
Detailed description
Articular noise is common after total knee arthroplasty (TKA), yet there is ongoing debate regarding its effect on postoperative outcomes, joint awareness and patient satisfaction. A comparative study on articular noise in 50 patients undergoing bilateral TKA using two different prosthesis designs reported that an ultra-congruent design generated less noise than a posterior-stabilized design (18% compared with 38%; p= 0.026), but there were no differences in patient preference, satisfaction, or Forgotten Joint Score (FJS) at two-year follow-up. A retrospective analysis of 160 robot-assisted and 320 conventional TKA revealed no difference in the prevalence of articular noise (40.7% vs 38.1%; p=0.647), but patients who complained of noise had lower FJS (45.5 vs 66.1; p<0.001) and lower Knee Injury and Osteoarthritis Score Joint Replacement (KOOS-JR) scores (72.0 vs 81.4; p<0.001) at one-year follow-up.
Recent advancements have shifted medicine from standardised approaches to personalised or precision medicine, tailoring treatments and decisions for individual patients based on their specific responses and risk factors. Individualized TKA adapts features to align with pre-arthritic anatomy and restore native movement, often utilising various tools. Recent studies on individualized TKA have demonstrated promising outcomes regarding personalised coronal alignment targets, correction of extra-articular deformities, intra-operative workflow, accommodation of the third compartment, and patient satisfaction rates.
This study will compare a posterior-stabilised (PS) and a cruciate-retaining (CR) individualized TKA implant. The PS implant is selected for patients with a damaged or a non-functional posterior cruciate ligament. In this case, the ligament is removed and substituted with a post-cam mechanism that aids femoral rollback during knee flexion and avoids anterior femoral subluxation. In contrast, the CR implant design can be selected for patients with an intact and functional posterior cruciate ligament. In this case, the ligament is retained, allowing it to guide femoral rollback and prevent anterior subluxation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomised controlled single-blinded monocentre trial in a superiority framework with a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| PS-group | Experimental | Device: Postero-stabilized total knee replacement for knee osteoarthritisIndividualized PS TKA |
| CR-group | Active comparator | Device: Cruciate-retaining total knee replacement for knee osteoarthritisIndividualized CR TKA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- receiving elective primary TKA as a treatment for osteoarthritis
- with an intact and functional posterior cruciate ligament
- with no previous knee surgery, on the ipsi- or contra-lateral knee
- who signed the informed consent and are willing to comply with the protocol requirements based on the investigator's judgment.
- affiliated with a social security scheme
Key exclusion criteria (8 listed)
- that underwent previous knee surgery, except arthroscopic surgery, on their ipsilateral knee
- with coronal deformities >20°
- that are pregnant
- any contraindication mentioned in the instructions for use of the medical devices under investigation
- 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 |
|---|---|---|
| Postero-stabilized total knee replacement for knee osteoarthritisTotal knee arthroplasty in which the osteoarthritic knee is replaced with a postero-stabilized total knee replacement. The postero-stabilized TKA consists of a femoral component with a build-in cam mechanism and a tibial component with a post-mechanism. | Device | PS-group |
| Cruciate-retaining total knee replacement for knee osteoarthritisTotal knee arthroplasty in which the osteoarthritic knee is replaced with a cruciate-retaining total knee replacement. The cruciate-retaining TKA consists of a femoral component and a tibial component that leaves the posterior cruciate ligament intact. | Device | CR-group |
Primary outcome
Do you hear noise originating from your knee?
Time frame: 2 years
The surgeon will ask the blind participant whether they hear articular noise originating from their knee two years after TKA.
5 secondary outcomes
Do you feel noise?
Time frame: 1 & 2 years
Is the noise a concern or causing discomfort?
Time frame: 1 & 2 years
What kind of noise do you hear of feel?
Time frame: 1 & 2 years
What part of the knee is involved?
Time frame: 1 & 2 years
What is the impact of the noise on your quality of life, on a scale from 0 (none) to 10 (severe)?
Time frame: 1 & 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 26 Jun 2025.
- Individual participant dataSharing planned: No. It goes against GDPR and other EU regulations
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Postero-stabilized total knee replacement for knee osteoarthritis and Cruciate-retaining total knee replacement for knee osteoarthritis in people with Osteoarthritis and TKA, run by Clinique Trenel.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Johanne Beuvelot Beuvelot, PhD (0033 67623373, johanne.beuvelot@clinique-trenel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Do you hear noise originating from your knee? (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2025.