Abstract
Background
Use of a robotic tool to perform surgery introduces a risk of unexpected soft tissue damage due to the lack of tactile feedback for the surgeon. Early experience with robotics in total hip and knee replacement surgery reported having to abort the procedure in 18–34 percent of cases due to inability to complete preoperative planning, hardware and soft tissue issues, registration issues, as well as concerns over actual and potential soft tissue damage. These damages to the soft tissues resulted in significant morbidity to the patient, negating all the desired advantages of precision and reproducibility with robotic assisted surgery. The risk of soft tissue damage can be mitigated by haptic software prohibiting the cutting tip from striking vital soft tissues and by the surgeon making sure there is a clear workspace path for the cutting tool. This robotic total knee system with a semi-active haptic guided technique was approved by the FDA on 8/5/2015 and commercialized in August of 2016. One year clinical results have not been reported to date.
Objective
To review an initial and consecutive series of robotic total knee arthroplasties for safety in regard to avoidance of known or delayed soft tissue injuries and the necessity to abort the robotic assisted procedure and resort to the use of conventional implantation. Report the clinical outcomes with robotic total knee replacement at or beyond one year to demonstrate satisfactory to excellent performance.
Methods
The initial consecutive series of 100 robotic total knee replacements using a semi-active haptic guided system including 34 from the initial IDE series in 2014 and those performed after commercial approval beginning in 2016 were reviewed. Pre- operative planning utilizing CT determined the implant placement and boundaries and thus the limit of excursion from any part of the end effector saw tip. Self-retaining retractors were also utilized. Operative reports, 2, 6, and 12 week, and yearly follow-up visit reports were reviewed for any evidence of inadvertent injury to the medial collateral ligament, patellar tendon, or a neurovascular structure from the cutting tool. Operative notes were also reviewed to determine if the robotic procedure was partially or completely aborted due to any issue. Knee Society and Functional scores were recorded from pre-operative and yearly.
Results
No cases were unable to be completed robotically. No case had evidence for acute or delayed injury to the medial collateral ligament, patellar tendon, or neurovascular structure. The average follow-up for this series was 1.54 years. Average pre- operative Knee Society and Functional Scores improved from 44.7 and 50 to 98.1 and 87.8 at one year follow-up, 93.8 and 83.1 at two year follow-up, 98.5 and 87.7 at three year follow-up, and 99 and 85 at four year follow-up.
Conclusions
A semi-active haptic guided robotic system is a safe and reliable method to perform total knee replacement surgery. Preliminary short-term outcomes data shows excellent clinical and functional results.
