Total Knee Arthroplasty
Conditions
Interventions
Knee Balancer Solver plus MAKO Robot-Assisted TKA group:Total Knee Arthroplasty Assisted by a Knee Balancer Solver Combined with the MAKO Surgical Robot
MAKO Robot-Assisted TKA Alone group:Total Knee Arthroplasty Assisted by the MAKO Surgical Robot Alone
Sponsors
Beijing Jishuitan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18~80 years old, gender is not limited; 2. The patient is diagnosed with knee osteoarthritis and requires primary unilateral TKA surgery after ineffective conservative treatment; 3. The first unilateral total knee replacement surgery is confirmed by the investigator for the second time; 4. Preoperative examination shows no contraindications to surgery such as serious underlying diseases; 5. Subjects fully understand the benefits and risks of this trial, and are willing to participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previous history of knee, femur, tibia fracture or surgery; 2. Knee joint tumors require unconventional knee replacement surgery; 3. Presence of moderate or more operative knee deformity (varus, flexion deformity, etc.) and joint rigidity; 4. Combined hip and ankle joint diseases; 5. Those who have contraindications to knee replacement surgery, or have severe internal diseases such as heart, lung, liver, kidney, and blood and cannot tolerate surgery; 6. Patients with knee infection or revision; 7. Body mass index (BMI) > 40kg/m^2; 8. Language barriers and inability to complete relevant scores; 9. Severe neuromuscular disease; 10. Limb neuropathy on the surgical side; 11. Patients with mental illness; 12. Patients with missing case data or imaging data or lost follow-up; 13. Patients who have participated in other clinical studies such as drugs and devices and have reached the study endpoint for less than 3 months before inclusion; 14. Those who are not suitable for clinical trials in the opinion of other investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee injury and Osteoarthritis Outcome Score (KOOS) at 1 year postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional outcomes: Visual Analogue Scale (VAS), Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Forgotten Joint Score-12 (FJS-12), and Range of Motion (ROM);Radiographic measurements: Hip–knee–ankle angle (HKA), femoral angle, tibial angle, knee valgus angle, femoral component flexion angle, tibial slope at 90°;Operative time;Total blood loss;Postoperative complications;Adverse events; | — |
Countries
China
Contacts
Public ContactXiangdong Wu
Beijing Jishuitan Hospital, Capital Medical University
Outcome results
None listed