Knee Arthritis
Conditions
Brief summary
The purpose of this study is to compare the outcomes and accuracy of implant positioning in robotic assisted total knee arthroplasty with traditional manually instrumented total knee arthroplasty.
Interventions
Manually instrumented implantation of a total knee prosthesis involves use of cutting guides or jigs that are secured to the femur and the tibia. The femoral guide is secured to the femur after an intramedullary referenced guide is placed into the femur and the rotational alignment is then assessed with use of the epicondylar axis. An extra-medullary tibial alignment guide will be used to create the tibial cut.
Robotically assisted surgery is used in conjunction with the preoperative CT scan and intra-operative bony registration of the patient's knee. Femoral and tibial trackers are placed and then the bone is registered using bony landmarks to allow the computer and robot to know where the patients' femur and tibia are in space. Once this is complete the preoperative templated surgical plan (performed by the PI) is used to register where to make the bony cuts in order to implant the knee components. The cutting process is performed by the surgeon with the robot assisting in guiding the cuts based on the registered CT anatomy. The surgeon has complete control of the cutting process with the assistance of the robot for placement of the cuts.
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients who have knee pain and are candidates for total knee arthroplasty * Patients able to consent to be included in the study
Exclusion criteria
* Patients with previous total or partial knee arthroplasty in need of revision surgery * Patients unable to or unwilling to undergo post-operative CT scans after understanding the risks and benefits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summation of angle differences between pre-operative plan and the final implant position as indicated by computed tomography (CT) | within 2 weeks before surgery, within one month of surgery | The absolute value of the individual differences in various angle measurements will be added together to form a total summation of angle difference. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain as assessed by the PROMIS 10 measurement system | within 2 weeks before surgery | Patient-Reported Outcomes Measurement Information System (PROMIS) |
| Function as assessed by the PROMIS 10 measurement system | within 2 weeks before surgery | — |
| Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system | within 2 weeks before surgery | — |
| Pain as assessed by a Visual Analogue Scale (VAS) | within 2 weeks before surgery | Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain. |
Countries
United States