Total Hip/Knee Arthroplasty, Unicompartmental Knee Arthroplasty, Hip/Knee Revision Surgery
Conditions
Interventions
Total hip arthroplasty group:Experimental group: Robot-assisted total hip arthroplasty (THA) using the novel joint-replacement robot. (n=40)
Control group: Robot-assisted THA using the Mako robotic-a
Total knee arthroplasty group:Experimental group: Robot-assisted total knee arthroplasty (TKA) using the novel joint-replacement robot. (n=40)
Control group: Robot-assisted TKA using the Mako robotic
Unicompartmental knee arthroplasty group:Experimental group: Robot-assisted unicompartmental knee arthroplasty (UKA) using the novel joint-replacement robot. (n=40)
Control group: Robot-assisted UKA
Robot-assisted revision total hip arthroplasty:Robot-assisted revision total hip arthroplasty (rTHA) using the novel joint-replacement robot (n = 10).
Note: Owing to substantial inter-patient heteroge
>=10 cases each of robot-assisted revision THA and revision TKA will be performed with the novel robot.
Robot-assisted revision total knee arthroplasty:Robot-assisted revision total knee arthroplasty (rTKA) using the novel joint-replacement robot (n = 10).
Note: Owing to substantial inter-patient hetero
>= 10 cases each of robot-assisted revision THA and revision TKA will be performed with the novel robot.
Sponsors
Beijing Jishuitan Hospital, Capital Medical University, Fourth Clinical College of Peking University, National Center for Orthopaedics
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: a) Age: 18–80 years, regardless of gender; b) Patients who have signed informed consent and agreed to participate in this study; c) Patients meeting the criteria for surgery eligibility.
Exclusion criteria
Exclusion criteria: a) Pregnant female patients; b) Patients older than 80 years; c) Patients with active infectious foci, including acute or chronic local joint infections or systemic infections; d) Patients who cannot undergo general or spinal anesthesia; e) Patients with severe systemic diseases; f) Patients with coagulation disorders; g) Patients whose bone conditions preclude prosthesis implantation; h) Patients with other metallic implants in the surgical area; i) Patients with known allergies to one or more implant materials; j) Patients with neuromuscular disorders such as paralysis or muscular weakness; k) Patients with chronic pain conditions other than arthritis, requiring long-term analgesic medication; l) Patients deemed unsuitable for the trial by the investigator. Patients should not be enrolled in the unicompartmental knee arthroplasty (UKA) trial if any of the following are present: m) lower-extremity mechanical-axis varus >10°, and/or a fixed flexion deformity of the knee >15°, and/or severe patellofemoral osteoarthritis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of implant positioning;Functional outcome scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| Operative time;Number of repeated operations by the robotic arm;Satisfaction with device performance; | — |
Countries
China
Contacts
Public ContactYixin Zhou
Beijing Jishuitan Hospital, Capital Medical University, Fourth Clinical College of Peking University, National Center for Orthopaedics
Outcome results
None listed