Total Knee Arthroplasty and Augmented Reality-based Navigation System
ConditionGonarthrosis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorElsan
About this trial
The purpose of Total Knee Replacement (TKR) is to remove worn cartilage surfaces and replace them with artificial parts of the same shape. TKR can be used in cases of osteoarthritis, inflammatory rheumatism, bone necrosis of the knee or following malformative or traumatic sequelae.
Implant alignment is paramount in TKR and the last years have seen a proliferation of alignment techniques following the introduction of computer and robotic-assisted surgery. Among Computer-assisted surgery, the augmented reality-based navigation system can be an option to improve accuracy in orthopaedic surgery.
The hypothesis of this study is: the use of augmented reality-based navigation system allows a prosthesis alignment and positioning that is at least as good as with the traditional mechanically aligned technique, and therefore improves knee functional results. This study also aims at assessing the cost-effectiveness of this new technology.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Gonarthrosis on a varum knee requiring a Total Knee Replacement
Female or male, 18 years of age or older
Affiliation to a social security scheme
Patient has been informed of the study and has signed an informed consent form
Disqualifiers
Osteonecrosis,
Post traumatic osteoarthritis with femoral or tibial callus,
History of tibial or femoral osteotomy,
Valgum knee,
Trial design
Design model
Parallel
Treatments tested in this trial
TKR with augmented reality-based navigation system
Procedure/SurgerySurgery
TKR with traditional mechanically aligned technique
Procedure/SurgeryAs per local practice and standard guidelines.
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: TKR with augmented reality-based navigation system.Experimental treatment 1 intervention
Group B: TKR with traditional mechanically aligned technique.Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Radiographic evaluation of the Hip-Knee-Ankle (HKA) angle
the Hip-Knee-Ankle (HKA) angle is measured on weight bearing pangonogram.
Time frame
2 months after surgerySecondary outcomes
1
Evaluation of long-term lower limb alignment between the two procedures
Radiographic evaluation of the Hip-Knee-Ankle (HKA) angle on lower limb pangonogram at 1 year after surgery
Time frame
1 year after surgery2
Evaluation of the success of the procedure
The success of the procedure is defined by an HKA angle of 180°
Time frame
2 months after surgery3
Assessment of lower limb alignment variability between the two procedures.
Radiographic evaluation of the Hip-Knee-Ankle (HKA) angle on lower limb pangonogram at 2 months and 1 year after surgery.
Time frame
2 months and1 year after surgery4
Evaluation of radiological measurements between the two procedures
Evolution of the following radiological parameters at 2 months and 1 year post-surgery: Femoral valgus Tibial varus Posterior tibial slope Flessum of the femoral implant Patellar tilt
Time frame
2 months and1 year after surgeryOther outcomes
1
Radiographic assessment
The primary endpoint of this research will be radiographic assessment of the Hip-Knee-Ankle (HKA) angle on weight-bearing lower extremity pangonometry at 2 months after surgery.
Time frame
At 2 months after surgery Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: