knee osteoarthritis
Conditions
Interventions
measured resection group:measured resection
gap balancing group:gap balancing
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) After symptoms, physical examination and imaging examination, the patient was diagnosed as primary knee osteoarthritis with X-ray K-L stage III or above (2) Severe knee pain, limited function, conservative treatment failed, unilateral primary knee replacement was proposed (3) No severe varus deformity of knee joint (varus > 20° or valgus > 10°). (4) The commercially available Mako total knee replacement system, compatible with the robot-assisted system, was available to the patient in the judgment of the study physician.
Exclusion criteria
Exclusion criteria: 1. Patients scheduled to undergo bilateral total knee arthroplasty within 3 months. 2. Patients with previous ipsilateral revision partial or total knee arthroplasty. 3. Patients with bone tumors who had undergone bilateral knee arthroplasty. 4. Patients who had undergone ipsilateral stable painless knee arthrodesis with satisfactory functional position. 5.Patients scheduled for primary total knee arthroplasty had undergone contralateral partial or total knee arthroplasty within 6 months before surgery. 6. Patients with joint area mobility, local infection or previous intra-articular infection. 7. Patients with insufficient bone mass on the femoral or tibial surfaces of the knee. 8. Patients with skeletal immaturity. 9. The patient has osteomalacia or any metabolic disorder that may impair bone formation. 10. The patient has a neurological disorder (e.g., a stroke in the brain). 11. The patient has diseases that can cause instability of the prosthesis, failure of the prosthesis fixation, or postoperative complications (e.g., spinal lesions, scoliosis, lumbar spinal stenosis, etc.). 12. The patient has cuboid joint disease with significant bone loss (e.g., avascular necrosis of the femoral head with collapse, severe dysplasia of the femoral head or cuboid socket). 13. The patient has hip disease with severely limited range of motion (e.g., arthrodesis, severe contracture, chronic severe dislocation). 14. Patients with severe knee instability due to incomplete collateral ligaments, cruciate ligaments and injuries to posterolateral structures. 15. The patient had rheumatoid arthritis with skin ulcers or a history of repeated skin ruptures. 16. Patients with severe knee deformity varus >= 20° or valgus >=10°. 17. The patient has a known or suspected sensitivity or allergy to one or more implant materials. 18. The patient had other contraindications as specified by the implant manufacturer. 19. The patient is pregnant or lactating or is a protected group (e.g. prisoners, mentally incapacitated persons). 20. Patients enrolled in another clinical trial within one month before signing the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Society Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| time of operation;Evaluation of intraoperative and postoperative blood loss;Postoperative pain assessment of affected limb;Patient satisfaction evaluation; | — |
Countries
China
Contacts
Public ContactHua Tian
Peking University Third Hospital
Outcome results
None listed