Evaluation Protocol of the Installation of Knee Unicompartmental Prosthesis (Journey (Smith & Nephew)) With Mechanical Ancillary Versus Robotic Assisted (Navio System).
NCT ID: NCT03469193
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
66 participants
INTERVENTIONAL
2018-04-17
2022-01-21
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
internal PUC implanted with mechanical ancillary
internal PUC implanted with mechanical ancillary
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 assistance
Internal PUC implanted with robotic assistance
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
internal PUC implanted with mechanical ancillary
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 assistance
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of unicompartmental knee osteoarthritis ( osteoarthritis internal femoral tibial (AFTI))
* Indication of unicompartmental knee arthroplasty of first intention posed
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Smith & Nephew, Inc.
INDUSTRY
Hospices Civils de Lyon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sebastien Lustig
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hopital de la Croix Rousse
Lyon, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-A03292-51
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL17_0512
Identifier Type: -
Identifier Source: org_study_id