Journal
JOURNAL OF ORTHOPAEDICS
Volume 26, Issue -, Pages 119-125Publisher
ELSEVIER
DOI: 10.1016/j.jor.2021.07.001
Keywords
Primary TKA; Active robotic TKA; Safe; Effective
Categories
Funding
- Think Surgical, Inc. [16-PROTO-01]
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The study found that the new active robotic system for total knee arthroplasty was safe and effective in a US population, with no predefined adverse events occurring and only 11.2% of cases having postoperative limb alignment more than +/- 3 degrees from the plan.
Background: A novel active robotic system for total knee arthroplasty (TKA) performs automated milling of bone surfaces. Study objectives were to assess system safety and effectiveness in a US population. Methods: A multicenter clinical trial was conducted, following 115 patients for at least 6-months. A pre-defined list of robot-related adverse events was used to evaluate safety. Efficacy was assessed radiographically comparing planned versus achieved corona' limb alignment. Results: No pre-defined adverse events occurred and postoperative limb alignment more than +/- 3 degrees from plan occurred in 11.2 % of cases. Conclusion: Active robotics for TKA is safe and effective as demonstrated in this trial.
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