Clinical trial NCT05233930: Total Knee Arthroplasty and Augmented Reality-based Navigation System
Official title: Does an Augmented Reality-based Navigation System in Total Knee Arthroplasty Allow a Better Alignment of the Lower Limb and Does it Improve Functional Results ? An Equivalence, Monocentric, Prospective and Randomized Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gonarthrosis
Keywords: TKR: total knee replacement
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, double-arms, parallel, open-label study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: In this randomised study, TKR will be performed either with the traditional mechanically aligned technique or with an augmented reality-based navigation system using Knee+ technology.

Knee+ is a Class Im software medical device (European classification, Directive 93/42/EEC, Annex IX) and obtained CE Mark 0459 in May 2020.

This technology is used in total knee replacement procedures, and offers the orthopedic surgeon intraoperative assistance in positioning the implants with the help of a pair of augmented reality glasses. The cutting planes are oriented with respect to the mechanical axes calculated according to anatomical landmarks acquired with a pointer. The connected glasses calculate precisely the 3D coordinates of the instruments thanks to the analysis of their specific markers (QR-Code), filmed by the integrated camera. The navigation information is displayed in the surgeon's field of vision, who interacts with the application thanks to the glasses' accelerometers.

Eligibility criteria: Inclusion Criteria:

1. Gonarthrosis on a varum knee requiring a Total Knee Replacement
2. Female or male, 18 years of age or older
3. Affiliation to a social security scheme
4. Patient has been informed of the study and has signed an informed consent form

Exclusion Criteria:

1. Osteonecrosis,
2. Post traumatic osteoarthritis with femoral or tibial callus,
3. History of tibial or femoral osteotomy,
4. Valgum knee,
5. Isolated patellofemoral osteoarthritis,
6. Significant hip dysplasia or other excessive pelvic deformity,
7. Patient already equipped with medical devices that may conflict with the instrumentation required for augmented reality navigation,
8. Pregnant or breastfeeding women,
9. Patients under legal protection.

Primary outcomes:
measure: Radiographic evaluation of the Hip-Knee-Ankle (HKA) angle
timeFrame: 2 months after surgery
Secondary outcomes:
measure: Evaluation of long-term lower limb alignment between the two procedures
timeFrame: 1 year after surgery
measure: Evaluation of the success of the procedure
timeFrame: 2 months after surgery
measure: Assessment of lower limb alignment variability between the two procedures.
timeFrame: 2 months and1 year after surgery
measure: Evaluation of radiological measurements between the two procedures
timeFrame: 2 months and1 year after surgery
measure: Evaluation of the knee score between the two procedures
timeFrame: 2 months and1 year after surgery
measure: Quality of life assessment between the two procedures
timeFrame: 2 months and1 year after surgery
measure: Evaluation of knee pain between the two procedures
timeFrame: From day 0 to day 5 ; Once a week during 1 month ; at 2 months ; at 3 months and 1 year after surgery
measure: Evaluation of the hemoglobin level between the two procedures
timeFrame: From day 1 to day 3 after surgery
measure: Evaluation of the Average Length of Stay between the two procedures
timeFrame: From the day of surgery at the time of hospital discharge up to 1 day
measure: Evaluation of the postoperative complications rate between the two procedures
timeFrame: During 1 year post-operative
measure: Evaluation of the Quality-Adjusted Life Years (QALY) between the two procedures
timeFrame: At 1 year
Other outcomes:
measure: Radiographic assessment
timeFrame: At 2 months after surgery
Locations:
city: Aurillac
country: France
facility: Centre Médico-Chirurgical de Tronquières
Study officials:
affiliation: Centre Médico-Chirurgical de Tronquières
name: Frédéric Dalat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Panjwani TR, Mullaji A, Doshi K, Thakur H. Comparison of Functional Outcomes of Computer-Assisted vs Conventional Total Knee Arthroplasty: A Systematic Review and Meta-Analysis of High-Quality, Prospective Studies. J Arthroplasty. 2019 Mar;34(3):586-593. doi: 10.1016/j.arth.2018.11.028. Epub 2018 Dec 2.
citation: Cheng T, Pan XY, Mao X, Zhang GY, Zhang XL. Little clinical advantage of computer-assisted navigation over conventional instrumentation in primary total knee arthroplasty at early follow-up. Knee. 2012 Aug;19(4):237-45. doi: 10.1016/j.knee.2011.10.001. Epub 2011 Nov 29.