Osteoarthritis Of KneePUC NAVIONCT03469193
Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System).
A study testing internal PUC implanted with mechanical ancillary and Internal PUC implanted with robotic assistance in people with Osteoarthritis Of Knee, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Unicompartmental knee arthroplasty by unicompartmental prosthesis (PUC) is a treatment for isolated internal femoro-tibial osteoarthritis. This intervention is justified in cases of significant discomfort, failure of medical treatment and the absence of osteoarthritis in femoro tibial external and patellofemoral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Of Knee
- What is being tested?
- internal PUC implanted with mechanical ancillary and Internal PUC implanted with robotic assistance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2018to 21 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male or female adult (age ≥ 18 years)
- Diagnosis of unicompartmental knee osteoarthritis ( osteoarthritis internal femoral tibial (AFTI))
- Indication of unicompartmental knee arthroplasty of first intention posed
Who cannot join
- History of femoral or tibial osteotomy of valgization or varisation
- Reconstruction of the associated cruciate ligament
- Refusal to participate in the study
- Pregnant women, parturient or nursing mothers
- Persons deprived of their liberty by a judicial decision or administrative staff, persons under psychiatric care, persons admitted to a health or social institution to other purposes.
- Major persons subject to a legal protection measure or unable to express their consent
- Patient not affiliated to a social security scheme
- Patient participating in another interventional research excluding routine care research (former regulation) and category 2 searches not interfering with criterion analysis main
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System). Prospective, Monocentric, Randomized, Open Label Study.
Unicompartmental knee arthroplasty by unicompartmental prosthesis (PUC) is a treatment for isolated internal femoro-tibial osteoarthritis. This intervention is justified in cases of significant discomfort, failure of medical treatment and the absence of osteoarthritis in femoro tibial external and patellofemoral femoro compartments. It aims to replace the native internal femoral tibial articulation by a joint between two implants, without intervening on the other compartments. The functional results of PUC are superior and faster than those obtained with total knee arthroplasty (TKA). Its indications and its realization are on the other hand very demanding to allow an optimal functional result.
Robotic-assisted surgery provides an excellent level of precision, which could allow better positioning of implants, compared to the use of a mechanical ancillary, according to the first published studies. The functional results and survival of these implants could also be improved.
Read more
The internal PUC with mechanical ancillary is carried out for many years in the orthopedic surgery department of Croix Rousse. For 3 years this surgery is sometimes performed with robotic assistance.
The investigators would like to prospectively evaluate the clinical and radiological impact of robotic-assisted surgery when performing a Journey unicompartmental prosthesis (Smith \& Nephew).
The assessment of alignment during walking seems to be a paramount parameter in the results of the PUC and has not so far been evaluated in this type of robotic-assisted surgery.
- Conditions
- Osteoarthritis Of Knee
- Being tested
- internal PUC implanted with mechanical ancillary, Internal PUC implanted with robotic assistance
- Keywords
- knee unicompartmental prosthesis, KneeKG system, robotic-assisted, alignment, implants positioning, International Knee Society, Forgotten joint score
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internal PUC implanted with mechanical ancillaryProcedure or surgery
The control group consists of patients operated with a mechanical ancillary (reference surgery in our department). In this technique, bone sections are made with a standardized ancillary (manually adjusted bone cutting guides), according to preoperative radiological planning. The positioning of the implants is done manually and controlled by the placement of test implants.
Internal PUC implanted with robotic assistanceProcedure or surgery
Patients are operated by robotics (surgery that we want to develop systematically in our service). 3D modeling of the knee allows the operator to perform a dynamic planning taking into account the reducibility of the deformation and the model of the implant. The operator can position the implants in three dimensions of the space without difficulty. This makes it possible to visualize, before the bone resections, the angular correction obtained between 0 and 130° flexion and alignment of the prosthesis by visualizing the contact points between the two implants. Bone resections will be performed using a guided retro bone drill. The system retracts more or less the cutter according to the bone thickness to be removed. This technique requires the insertion of two threaded plugs in the tibia and two in the femur to position the sensors that will allow the acquisition of anatomical landmarks of the lower limb and then 3D modeling
| Study group | Role | What they receive |
|---|---|---|
| internal PUC implanted with mechanical ancillary | Active comparator | Not described Receives: Procedure: internal PUC implanted with mechanical ancillary |
| Internal PUC implanted with robotic assistance | Experimental | Not described Receives: Procedure: Internal PUC implanted with robotic assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with Angle Hip Knee Ankle (HKA) (lower limb axis) restitution at 178 ° +/- 2 ° when the foot is touched with the floor and during the single support phase.
This criterion will be measured using a KneeKG system for dynamic analysis of knee movements.
This system is non-invasive, non-radiating, non-painful. It is a dynamic tibiofemoral tracing device by infrared camera validated. The KneeKG system will be used according to its instructions for use.
Measured: At 6 month postsurgery
Secondary outcomes (3)
Radiological positioning of implants
Measurements of HKA, frontal alignment of tibial and femoral implants, sagittal alignment of the femoral implant, tibial implant slope and the presence of peri-prosthetic edgings will be performed on a Standard radiography of the knee operated from the front, in profile and on a standing pangonometry
Measured: At 6 month and 24 month postsurgery
Comparison of the means of the International Knee Society (IKS) overall score between the groups.
This is the international benchmark for clinical and functional evaluation in knee surgery. The 2011 version provides a more accurate, complete and comprehensive vision than the previous version.
Measured: At 6 month and 24 month postsurgery
Comparison of the Forgotten Joint Score
The Forgotten score helps to analyze the patient's attention to the fact that his articulation has been replaced.
Measured: At 6 month and 24 month postsurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start17 Apr 2018
- Primary completion10 Jul 2020
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis Of KneeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Sponsor
- Investigators
- Sebastien Lustig, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469193
- Sponsor's protocol ID
- 69HCL17_0512
- Other IDs
- 2017-A03292-51
- Acronym
- PUC NAVIO
- Status last verified
- Dec 2025
- First submitted
- 12 Mar 2018
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Batailler C, Lording T, Naaim A, Servien E, Cheze L, Lustig S. No difference of gait parameters in patients with image-free robotic-assisted medial unicompartmental knee arthroplasty compared to a conventional technique: early results of a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2023 Mar;31(3):803-813. doi: 10.1007/s00167-021-06560-5. Epub 2021 Apr 11.
PubMed 33839803
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System). Prospective, Monocentric, Randomized, Open Label Study.
- ClinicalTrials.gov ID
- NCT03469193
- Acronym / sponsor ID
- PUC NAVIO / 69HCL17_0512
- Conditions
- Osteoarthritis Of Knee
- Keywords
- knee unicompartmental prosthesis, KneeKG system, robotic-assisted, alignment, implants positioning, International Knee Society, Forgotten joint score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 19 Mar 2018 (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.
Unicompartmental knee arthroplasty by unicompartmental prosthesis (PUC) is a treatment for isolated internal femoro-tibial osteoarthritis. This intervention is justified in cases of significant discomfort, failure of medical treatment and the absence of osteoarthritis in femoro tibial external and patellofemoral femoro compartments. It aims to replace the native internal femoral tibial articulation by a joint between two implants, without intervening on the other compartments. The functional results of PUC are superior and faster than those obtained with total knee arthroplasty (TKA). Its indications and its realization are on the other hand very demanding to allow an optimal functional result.
Robotic-assisted surgery provides an excellent level of precision, which could allow better positioning of implants, compared to the use of a mechanical ancillary, according to the first published studies. The functional results and survival of these implants could also be improved.
The internal PUC with mechanical ancillary is carried out for many years in the orthopedic surgery department of Croix Rousse. For 3 years this surgery is sometimes performed with robotic assistance.
The investigators would like to prospectively evaluate the clinical and radiological impact of robotic-assisted surgery when performing a Journey unicompartmental prosthesis (Smith \& Nephew).
The assessment of alignment during walking seems to be a paramount parameter in the results of the PUC and has not so far been evaluated in this type of robotic-assisted surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| internal PUC implanted with mechanical ancillary | Active comparator | Procedure: internal PUC implanted with mechanical ancillary |
| Internal PUC implanted with robotic assistance | Experimental | Procedure: Internal PUC implanted with robotic assistance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female adult (age ≥ 18 years)
- Diagnosis of unicompartmental knee osteoarthritis ( osteoarthritis internal femoral tibial (AFTI))
- Indication of unicompartmental knee arthroplasty of first intention posed
Key exclusion criteria (8 listed)
- History of femoral or tibial osteotomy of valgization or varisation
- Reconstruction of the associated cruciate ligament
- Refusal to participate in the study
- Pregnant women, parturient or nursing mothers
- Persons deprived of their liberty by a judicial decision or administrative staff, persons under psychiatric care, persons admitted to a health or social institution to other purposes.
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 |
|---|---|---|
| internal PUC implanted with mechanical ancillaryThe control group consists of patients operated with a mechanical ancillary (reference surgery in our department). In this technique, bone sections are made with a standardized ancillary (manually adjusted bone cutting guides), according to preoperative radiological planning. The positioning of the implants is done manually and controlled by the placement of test implants. | Procedure or surgery | internal PUC implanted with mechanical ancillary |
| Internal PUC implanted with robotic assistancePatients are operated by robotics (surgery that we want to develop systematically in our service). 3D modeling of the knee allows the operator to perform a dynamic planning taking into account the reducibility of the deformation and the model of the implant. The operator can position the implants in three dimensions of the space without difficulty. This makes it possible to visualize, before the bone resections, the angular correction obtained between 0 and 130° flexion and alignment of the prosthesis by visualizing the contact points between the two implants. Bone resections will be performed using a guided retro bone drill. The system retracts more or less the cutter according to the bone thickness to be removed. This technique requires the insertion of two threaded plugs in the tibia and two in the femur to position the sensors that will allow the acquisition of anatomical landmarks of the lower limb and then 3D modeling | Procedure or surgery | Internal PUC implanted with robotic assistance |
Primary outcome
proportion of patients with Angle Hip Knee Ankle (HKA) (lower limb axis) restitution at 178 ° +/- 2 ° when the foot is touched with the floor and during the single support phase.
Time frame: At 6 month postsurgery
This criterion will be measured using a KneeKG system for dynamic analysis of knee movements. This system is non-invasive, non-radiating, non-painful. It is a dynamic tibiofemoral tracing device by infrared camera validated. The KneeKG system will be used according to its instructions for use.
3 secondary outcomes
Radiological positioning of implants
Time frame: At 6 month and 24 month postsurgery
Comparison of the means of the International Knee Society (IKS) overall score between the groups.
Time frame: At 6 month and 24 month postsurgery
Comparison of the Forgotten Joint Score
Time frame: At 6 month and 24 month postsurgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 33839803Batailler C, Lording T, Naaim A, Servien E, Cheze L, Lustig S. No difference of gait parameters in patients with image-free robotic-assisted medial unicompartmental knee arthroplasty compared to a conventional technique: early results of a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2023 Mar;31(3):803-813. doi: 10.1007/s00167-021-06560-5. Epub 2021 Apr 11.
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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.
Sebastien Lustig principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internal PUC implanted with mechanical ancillary and Internal PUC implanted with robotic assistance in people with Osteoarthritis Of Knee, run by Hospices Civils de Lyon 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 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: finished, as of the sponsor's last update on 19 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
proportion of patients with Angle Hip Knee Ankle (HKA) (lower limb axis) restitution at 178 ° +/- 2 ° when the foot is touched with the floor and during the single support phase. (time frame: At 6 month postsurgery). 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 NCT03469193, which also lists 1 linked publication.
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 19 Dec 2025.