Gonarthrosis
Conditions
Keywords
TKR: total knee replacement
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.
Interventions
PROCEDURETKR with augmented reality-based navigation system
Surgery
PROCEDURETKR with traditional mechanically aligned technique
As per local practice and standard guidelines.
Sponsors
Elsan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised, double-arms, parallel, open-label study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic evaluation of the Hip-Knee-Ankle (HKA) angle | 2 months after surgery | the Hip-Knee-Ankle (HKA) angle is measured on weight bearing pangonogram. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of long-term lower limb alignment between the two procedures | 1 year after surgery | Radiographic evaluation of the Hip-Knee-Ankle (HKA) angle on lower limb pangonogram at 1 year after surgery |
| Evaluation of the success of the procedure | 2 months after surgery | The success of the procedure is defined by an HKA angle of 180° |
| Assessment of lower limb alignment variability between the two procedures. | 2 months and1 year after surgery | Radiographic evaluation of the Hip-Knee-Ankle (HKA) angle on lower limb pangonogram at 2 months and 1 year after surgery. |
| Evaluation of radiological measurements between the two procedures | 2 months and1 year after surgery | 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 |
| Evaluation of the knee score between the two procedures | 2 months and1 year after surgery | Evolution of the knee score at 2 months and 1 year postoperatively measured by the Knee Society Score (KSS). The KSS is a widely used clinician-assessed outcome score with good published validity data. The clinical part (Knee Score) of the KSS covers pain, range of motion, alignment and stability. The Function Score of the KSS covers patient mobility (walking distance and stairs) and potential walking aids. The KSS scoring scale ranges from 0 to 100 points for each part, with higher scores indicating less severe impairment. |
| Evaluation of knee pain between the two procedures | From day 0 to day 5 ; Once a week during 1 month ; at 2 months ; at 3 months and 1 year after surgery | Evolution of pain every day between D0 (postoperative) and D5, then once a week during the first month, then at 2 months, 3 months and at 1 year postoperative measured by a visual analog scale (VAS). The visual analog scale (VAS) for pain is a pain self-assessment tool. The patient defines his pain on a line 10cm long. The distance (in millimeters) from the left extremity defines the pain. The value zero corresponds to the lower limit defining the absence of pain and 100 to the upper limit corresponding to the worst pain imaginable. |
| Evaluation of the hemoglobin level between the two procedures | From day 1 to day 3 after surgery | Evolution of the hemoglobin level at D1 and D3 |
| Evaluation of the Average Length of Stay between the two procedures | From the day of surgery at the time of hospital discharge up to 1 day | The Average Length of Stay will be evaluated in days from the hospital's entry and exit records. |
| Evaluation of the postoperative complications rate between the two procedures | During 1 year post-operative | Occurrence of a thromboembolic complication (yes/no) during the 1-year post-operative follow-up. Occurrence of a surgical site infection (yes/no) during the 1-year post-operative follow-up. Occurrence of wound healing problems (yes/no) during the 1-year post-operative follow-up |
| Evaluation of the Quality-Adjusted Life Years (QALY) between the two procedures | At 1 year | EQ-5D questionnaire at 1 year and collection of all costs during the first postoperative year. |
| Quality of life assessment between the two procedures | 2 months and1 year after surgery | Change in quality of life at 2 months and 1 year measured by the Short Form-12 (SF-12) questionnaire. The SF-12 is a standardized self-questionnaire for measuring quality of life.The SF-12 is the shortened version of the SF-36. The SF-12 is made up of eight subscores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a scale from 0 to 100 on the assumption that each question has the same weight. The lower the score, the greater the handicap. The higher the score, the lower the handicap, i.e. a score of zero equals maximum handicap and a score of 100 equals zero handicap. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Radiographic assessment | At 2 months after surgery | 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. |
Countries
France
Contacts
Primary ContactFrédéric Dalat, MD
Outcome results
None listed