GonarthrosisNaviKneeNCT05435690
Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty
A study testing Computer-assisted arthroplasty in people with Gonarthrosis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Evaluation of a new navigation system in computer-assisted total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gonarthrosis
- What is being tested?
- Computer-assisted arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2023to 31 May 2026
- 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 man or woman who has signed the informed consent for participation in the study,
- Patient with primary uni or bilateral gonarthrosis
- For whom an indication for total knee arthroplasty has been given
Who cannot join
- History of fracture, arthroplasty or osteotomy of the knee
- Severe preoperative laxity warranting a constrained prosthesis
- Inflammatory rheumatic disease or any other progressive concomitant condition that may impact on the patient's functional prognosis
- Traumatic articular or extra-articular deformities of the lower limb
- Neurological disease, after-effects of a stroke
- Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
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- Patient not affiliated to the French social security system
- Patient under legal protection, guardianship or curatorship
- Patient already included in another therapeutic study protocol or having participated in another trial in the previous three months
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of a new navigation system in computer-assisted total knee arthroplasty.
Read the detailed description
Single-blind, randomised, prospective comparative study in two parallel groups (conventional or computer-assisted arthroplasty).
The patient will be evaluated during 3 visits: inclusion D0 (before arthroplasty), M3 (intermediate visit 3 months after arthroplasty) and M12 (final visit 12 months after arthroplasty).
- Conditions
- Gonarthrosis
- Being tested
- Computer-assisted arthroplasty
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-assisted arthroplastyDevice
Computer-assisted arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| Computer-assisted arthroplasty | Experimental | Not described Receives: Device: Computer-assisted arthroplasty |
| Conventional arthroplasty | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
KSS M12
Assessment of functional outcome at 12 months by Knee Scoring System (KSS) score
Measured: Month 12
Secondary outcomes (12)
KSS M3
Assessment of functional outcome at 3 months by Knee Scoring System (KSS) score
Measured: Month 3
KOOS JR M3
Functional self-evaluation of the knee joint: Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: Month 3
KOOS JR M12
Functional self-evaluation of the knee joint: Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: Month 12
EQ-5D M3
Quality of life evaluation on EuroQol 5D
Measured: Month 3
EQ-5D M12
Quality of life evaluation on EuroQol 5D
Measured: Month 12
FJS M3
Self-evaluation of patient satisfaction with Forgotten Joint Score (FJS)
Measured: Month 3
FJS M312
Self-evaluation of patient satisfaction with Forgotten Joint Score (FJS)
Measured: Month 12
Surgery duration
Surgery duration
Measured: Day 0
Hospitalization duration
Hospitalization duration
Measured: Month 1
Lower limb alignment
Measurement of lower limb alignment in degrees of varus or valgus at M3 and M12
Measured: Month 12
Postoperative outcome predictive factor
Description of a possible correlation between preoperative laxity and postoperative outcome
Measured: Month 1
Safety analysis
Descriptive analysis of adverse events
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start6 Jan 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonarthrosisStudies 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
- Single-blind, randomised, prospective comparative study in two parallel groups (conventional or computer-assisted arthroplasty).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435690
- Sponsor's protocol ID
- 2021-A01677-34
- Acronym
- NaviKnee
- Status last verified
- Nov 2025
- First submitted
- 14 Dec 2021
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Navigation System in Computer-assisted Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05435690
- Acronym / sponsor ID
- NaviKnee / 2021-A01677-34
- Conditions
- Gonarthrosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 28 Jun 2022 (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.
Evaluation of a new navigation system in computer-assisted total knee arthroplasty.
Detailed description
Single-blind, randomised, prospective comparative study in two parallel groups (conventional or computer-assisted arthroplasty).
The patient will be evaluated during 3 visits: inclusion D0 (before arthroplasty), M3 (intermediate visit 3 months after arthroplasty) and M12 (final visit 12 months after arthroplasty).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind, randomised, prospective comparative study in two parallel groups (conventional or computer-assisted arthroplasty).
| Arm | Type | Receives |
|---|---|---|
| Computer-assisted arthroplasty | Experimental | Device: Computer-assisted arthroplasty |
| Conventional arthroplasty | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult man or woman who has signed the informed consent for participation in the study,
- Patient with primary uni or bilateral gonarthrosis
- For whom an indication for total knee arthroplasty has been given
Key exclusion criteria (9 listed)
- History of fracture, arthroplasty or osteotomy of the knee
- Severe preoperative laxity warranting a constrained prosthesis
- Inflammatory rheumatic disease or any other progressive concomitant condition that may impact on the patient's functional prognosis
- Traumatic articular or extra-articular deformities of the lower limb
- Neurological disease, after-effects of a stroke
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 |
|---|---|---|
| Computer-assisted arthroplastyComputer-assisted arthroplasty | Device | Computer-assisted arthroplasty |
Primary outcome
KSS M12
Time frame: Month 12
Assessment of functional outcome at 12 months by Knee Scoring System (KSS) score
12 secondary outcomes
KSS M3
Time frame: Month 3
KOOS JR M3
Time frame: Month 3
KOOS JR M12
Time frame: Month 12
EQ-5D M3
Time frame: Month 3
EQ-5D M12
Time frame: Month 12
FJS M3
Time frame: Month 3
FJS M312
Time frame: Month 12
Surgery duration
Time frame: Day 0
Hospitalization duration
Time frame: Month 1
Lower limb alignment
Time frame: Month 12
Postoperative outcome predictive factor
Time frame: Month 1
Safety analysis
Time frame: Month 12
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 3 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-assisted arthroplasty in people with Gonarthrosis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 3 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KSS M12 (time frame: Month 12). 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 3 Dec 2025.