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
Qualifiers
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
Treatments tested in this trial
- TKR with augmented reality-based navigation system
- TKR with traditional mechanically aligned technique
Treatment groups
88 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov