OsteoarthritisCAN-ARDNCT07574762
Total Knee Arthroplasty With Personalized Implantation: Computer Navigation-Assisted Surgery Versus Robotic-Assisted Surgery
A study testing Robotic-Arm Assisted Surgery (RA) and Computer-Assisted Navigation (CAN) in people with Osteoarthritis, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
Trial summary
Title: Personalized Total Knee Arthroplasty: Computer-Assisted Navigation vs. Robotic Assistance (CAN-ARD). Summary: Knee osteoarthritis is frequently treated with Total Knee Arthroplasty (TKA). However, approximately 20% of patients remain dissatisfied following the procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Robotic-Arm Assisted Surgery (RA) and Computer-Assisted Navigation (CAN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2026to 26 Jan 2029
- 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
- Patient providing written informed consent according to regulatory requirements
- Male or female patients aged ≥18 years
- Patients undergoing primary total knee arthroplasty for osteoarthritis
- Use of Attune® prosthesis with posterior cruciate ligament retention (CR) and patellar resurfacing
Who cannot join
- History of ligament reconstruction
- Previous fracture or bone surgery (osteotomy) of the ipsilateral femur or tibia (except hip or ankle surgery)
- Preoperative knee stiffness with flexion contracture >15° or flexion <90°
- Individuals deprived of liberty by judicial or administrative decision
- Patients not affiliated with a social security system
- Patients unable to understand French
Show all 9Show fewer
- Patients with cognitive impairment
- Patients whose place of residence makes close clinical follow-up impossible -- Women of childbearing potential without effective contraception
- Pregnant or breastfeeding women
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
Groupe hospitalier Diaconesses Croix Saint Simon
Paris, Paris, 75020
About this study
Official title: Total Knee Replacement With Personalized Implantation Navigation-assisted Surgery Versus Robotic Assistance "CAN-ARD"
Title: Personalized Total Knee Arthroplasty: Computer-Assisted Navigation vs. Robotic Assistance (CAN-ARD).
Summary:
Read more
Knee osteoarthritis is frequently treated with Total Knee Arthroplasty (TKA). However, approximately 20% of patients remain dissatisfied following the procedure. This study aims to compare two surgical assistance technologies designed to improve prosthetic placement accuracy: Computer-Assisted Navigation (CAN) and Robotic-Arm Assistance (RA).
The primary objective is to determine if there is a significant difference in functional outcomes and the "forgotten joint" sensation (measured by the Forgotten Joint Score - FJS) between patients operated on with robotic assistance versus those with traditional navigation at 3, 12, and 24 months post-surgery. The study's hypothesis is that there is no major clinical difference between these two techniques when applied within a personalized alignment strategy.
Read the detailed description
Background and Rationale:
Personalized alignment in total knee arthroplasty combines the restoration of the patient's unique anatomy (restricted kinematic alignment) with joint stability. While computer-assisted navigation has been successfully used since 2003 to plan and control implant positioning, robotic assistance is gaining popularity due to its ability to perform more precise bone cuts using a haptic robotic arm. This study seeks to investigate whether this technical gain in precision translates into a real clinical benefit for the patient in terms of satisfaction and joint perception.
Study Design:
This is an interventional, prospective, randomized, single-center study. A total of 140 patients (70 per group) will be enrolled.
Interventions:
Participants will be randomly assigned to one of the following two arms:
Navigation Group: TKA implantation (Attune® CR) guided by an intraoperative computer navigation system.
Robotic Group: TKA implantation using a robotic-arm-assisted system (a motorized saw linked to the navigation software).
Follow-up and Evaluations:
Patients will be followed for 24 months. Evaluations will include:
Primary Endpoint: Forgotten Joint Score (FJS) at 3, 12, and 24 months.
Secondary Endpoints: Satisfaction and functional scores (KOOS, SKV, Net Promoter Score), range of motion measurements, operative time, and monitoring of any complications.
Target Population:
Adults (≥ 18 years) scheduled for primary total knee arthroplasty for osteoarthritis, with no history of major bone surgery on the affected limb.
- Conditions
- Osteoarthritis
- Being tested
- Robotic-Arm Assisted Surgery (RA), Computer-Assisted Navigation (CAN)
- Keywords
- Robotic, Navigation, Arthroplasty, Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-Arm Assisted Surgery (RA)Device
Total Knee Arthroplasty (TKA) performed using a robotic-arm-assisted system connected to navigation software. Like the navigation group, this arm utilizes the personalized alignment strategy and the Attune® CR prosthesis. Instead of manual cutting guides, the surgeon manipulates a robotic arm equipped with a motorized saw to perform the bone cuts according to the pre-planned digital model. This technology is intended to increase the precision of bone resections.
Computer-Assisted Navigation (CAN)Device
Total Knee Arthroplasty (TKA) performed using an intraoperative computer navigation system. The procedure follows a personalized alignment strategy (restricted kinematic alignment combined with joint stability). After creating a digital model of the knee and mapping anatomical landmarks, the navigation system assists the surgeon in manually positioning the bone cutting guides. The primary implant used is the Attune® CR (Cruciate-Retaining) prosthesis with patellar resurfacing.
| Study group | Role | What they receive |
|---|---|---|
| Robotic | Experimental | Patients undergoing Prosthetic knee arthroplasty under robotic assistance Receives: Device: Robotic-Arm Assisted Surgery (RA) |
| Navigation | Active comparator | Patients undergoing Prosthetic knee arthroplasty under navigation assistance Receives: Device: Computer-Assisted Navigation (CAN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forgotten Joint Score (FJS).
Assessment of the patient's ability to forget the artificial joint in daily life. Minimum score: 0, Maximum score: 100. A higher score indicates a better outcome (the patient is less aware of the prosthetic joint)
Measured: 3, 12, and 24 months postoperatively.
Secondary outcomes (6)
Knee Injury and Osteoarthritis Outcome Score (KOOS).
Evaluation of the patient's opinion about their knee and associated problems. Minimum score: 0, Maximum score: 100. A higher score represents a better outcome.
Measured: 3, 12, and 24 months postoperatively.
Self Knee Value (SKV).
Patient's subjective assessment of their knee as a percentage of a normal knee. Scale: 0% to 100%. A higher percentage represents a better outcome.
Measured: 3, 12, and 24 months postoperatively.
Net Promoter Score (NPS)
A single-question survey used to measure patient satisfaction and their willingness to recommend the surgical procedure to others. The score is calculated based on responses to a single question on a scale of 0 to 10 (where 0 is "not at all likely" and 10 is "extremely likely"). Respondents are grouped as Promoters (9-10), Passives (7-8), or Detractors (0-6). The final NPS is calculated by subtracting the percentage of Detractors from the percentage of Promoters, resulting in a score ranging from -100 to +100. A higher score indicates higher patient satisfaction
Measured: 3, 12, and 24 months postoperatively.
Active Range of Motion.
Measurement of the active flexibility (extension and flexion) of the operated knee using a goniometer. Measured in degrees
Measured: Preoperatively, and at 3 months, 12 months, and 24 months postoperatively.
Operative Time
Total duration of the surgical procedure, measured from the initial skin incision to the completion of skin closure.
Measured: During the surgical procedure (Day 0).
Incidence of Surgical and Postoperative Adverse Events.
Documentation of complications including:Intraoperative: Technology-related issues or interruption of surgical assistance. Postoperative: Revision surgery, manipulation under anesthesia, or implant loosening.
Measured: Through 24 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start26 Jan 2026
- Primary completion1 Sep 2028 (estimated)
- Study completion26 Jan 2029 (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 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07574762
- Sponsor's protocol ID
- 2025-A00665-44
- Acronym
- CAN-ARD
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clark TC, Schmidt FH. Robot-Assisted Navigation versus Computer-Assisted Navigation in Primary Total Knee Arthroplasty: Efficiency and Accuracy. ISRN Orthop. 2013 Jun 24;2013:794827. doi: 10.1155/2013/794827. eCollection 2013.
PubMed 24967115Geng X, Zheng Y, Li Y, Zhao M, Liu Y, Li Z, Cai H, Zhang M, Yan X, Sun Z, Lv X, Guo F, Li F, Tian H. Early Radiographic and Clinical Outcomes of Robotic-arm-assisted versus Conventional Total Knee Arthroplasty: A Multicenter Randomized Controlled Trial. Orthop Surg. 2024 Nov;16(11):2732-2740. doi: 10.1111/os.14196. Epub 2024 Aug 12.
PubMed 39135273
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Knee Replacement With Personalized Implantation Navigation-assisted Surgery Versus Robotic Assistance "CAN-ARD"
- ClinicalTrials.gov ID
- NCT07574762
- Acronym / sponsor ID
- CAN-ARD / 2025-A00665-44
- Conditions
- Osteoarthritis
- Keywords
- Robotic, Navigation, Arthroplasty, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 26 Jan 2029 (estimated)
- First posted
- 8 May 2026 (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.
Title: Personalized Total Knee Arthroplasty: Computer-Assisted Navigation vs. Robotic Assistance (CAN-ARD).
Summary:
Knee osteoarthritis is frequently treated with Total Knee Arthroplasty (TKA). However, approximately 20% of patients remain dissatisfied following the procedure. This study aims to compare two surgical assistance technologies designed to improve prosthetic placement accuracy: Computer-Assisted Navigation (CAN) and Robotic-Arm Assistance (RA).
The primary objective is to determine if there is a significant difference in functional outcomes and the "forgotten joint" sensation (measured by the Forgotten Joint Score - FJS) between patients operated on with robotic assistance versus those with traditional navigation at 3, 12, and 24 months post-surgery. The study's hypothesis is that there is no major clinical difference between these two techniques when applied within a personalized alignment strategy.
Detailed description
Background and Rationale:
Personalized alignment in total knee arthroplasty combines the restoration of the patient's unique anatomy (restricted kinematic alignment) with joint stability. While computer-assisted navigation has been successfully used since 2003 to plan and control implant positioning, robotic assistance is gaining popularity due to its ability to perform more precise bone cuts using a haptic robotic arm. This study seeks to investigate whether this technical gain in precision translates into a real clinical benefit for the patient in terms of satisfaction and joint perception.
Study Design:
This is an interventional, prospective, randomized, single-center study. A total of 140 patients (70 per group) will be enrolled.
Interventions:
Participants will be randomly assigned to one of the following two arms:
Navigation Group: TKA implantation (Attune® CR) guided by an intraoperative computer navigation system.
Robotic Group: TKA implantation using a robotic-arm-assisted system (a motorized saw linked to the navigation software).
Follow-up and Evaluations:
Patients will be followed for 24 months. Evaluations will include:
Primary Endpoint: Forgotten Joint Score (FJS) at 3, 12, and 24 months.
Secondary Endpoints: Satisfaction and functional scores (KOOS, SKV, Net Promoter Score), range of motion measurements, operative time, and monitoring of any complications.
Target Population:
Adults (≥ 18 years) scheduled for primary total knee arthroplasty for osteoarthritis, with no history of major bone surgery on the affected limb.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic | Experimental | Device: Robotic-Arm Assisted Surgery (RA)Patients undergoing Prosthetic knee arthroplasty under robotic assistance |
| Navigation | Active comparator | Device: Computer-Assisted Navigation (CAN)Patients undergoing Prosthetic knee arthroplasty under navigation assistance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient providing written informed consent according to regulatory requirements
- Male or female patients aged ≥18 years
- Patients undergoing primary total knee arthroplasty for osteoarthritis
- Use of Attune® prosthesis with posterior cruciate ligament retention (CR) and patellar resurfacing
Key exclusion criteria (9 listed)
- History of ligament reconstruction
- Previous fracture or bone surgery (osteotomy) of the ipsilateral femur or tibia (except hip or ankle surgery)
- Preoperative knee stiffness with flexion contracture >15° or flexion <90°
- Individuals deprived of liberty by judicial or administrative decision
- Patients not affiliated with a social security system
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 |
|---|---|---|
| Robotic-Arm Assisted Surgery (RA)Total Knee Arthroplasty (TKA) performed using a robotic-arm-assisted system connected to navigation software. Like the navigation group, this arm utilizes the personalized alignment strategy and the Attune® CR prosthesis. Instead of manual cutting guides, the surgeon manipulates a robotic arm equipped with a motorized saw to perform the bone cuts according to the pre-planned digital model. This technology is intended to increase the precision of bone resections. | Device | Robotic |
| Computer-Assisted Navigation (CAN)Total Knee Arthroplasty (TKA) performed using an intraoperative computer navigation system. The procedure follows a personalized alignment strategy (restricted kinematic alignment combined with joint stability). After creating a digital model of the knee and mapping anatomical landmarks, the navigation system assists the surgeon in manually positioning the bone cutting guides. The primary implant used is the Attune® CR (Cruciate-Retaining) prosthesis with patellar resurfacing. | Device | Navigation |
Primary outcome
Forgotten Joint Score (FJS).
Time frame: 3, 12, and 24 months postoperatively.
Assessment of the patient's ability to forget the artificial joint in daily life. Minimum score: 0, Maximum score: 100. A higher score indicates a better outcome (the patient is less aware of the prosthetic joint)
6 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS).
Time frame: 3, 12, and 24 months postoperatively.
Self Knee Value (SKV).
Time frame: 3, 12, and 24 months postoperatively.
Net Promoter Score (NPS)
Time frame: 3, 12, and 24 months postoperatively.
Active Range of Motion.
Time frame: Preoperatively, and at 3 months, 12 months, and 24 months postoperatively.
Operative Time
Time frame: During the surgical procedure (Day 0).
Incidence of Surgical and Postoperative Adverse Events.
Time frame: Through 24 months postoperatively.
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 8 May 2026.
- Background: PubMed 24967115Clark TC, Schmidt FH. Robot-Assisted Navigation versus Computer-Assisted Navigation in Primary Total Knee Arthroplasty: Efficiency and Accuracy. ISRN Orthop. 2013 Jun 24;2013:794827. doi: 10.1155/2013/794827. eCollection 2013.
- Background: PubMed 39135273Geng X, Zheng Y, Li Y, Zhao M, Liu Y, Li Z, Cai H, Zhang M, Yan X, Sun Z, Lv X, Guo F, Li F, Tian H. Early Radiographic and Clinical Outcomes of Robotic-arm-assisted versus Conventional Total Knee Arthroplasty: A Multicenter Randomized Controlled Trial. Orthop Surg. 2024 Nov;16(11):2732-2740. doi: 10.1111/os.14196. Epub 2024 Aug 12.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-Arm Assisted Surgery (RA) and Computer-Assisted Navigation (CAN) in people with Osteoarthritis, run by Groupe Hospitalier Diaconesses Croix Saint-Simon 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 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: looking for participants now, as of the sponsor's last update on 8 May 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 Younes KERROUMI, Clinical Research Physician (+33144643384, ykerroumi@hopital-dcss.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forgotten Joint Score (FJS). (time frame: 3, 12, and 24 months postoperatively.). 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 NCT07574762, 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 8 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.