Bernard N Stulberg1, Jayson D Zadzilka1, Stefan Kreuzer2, Yair D Kissin3, Ralph Liebelt4, William J Long5, Valentina Campanelli6. 1. St. Vincent Charity Medical Center, Cleveland, OH, USA. 2. Houston Methodist West Hospital, Houston, TX, USA. 3. Hackensack University Medical Center, Hackensack, NJ, USA. 4. North Carolina Specialty Hospital, Durham, NC, USA. 5. NYU Langone Medical Center, New York, NY, USA. 6. THINK Surgical, Inc., Fremont, CA, USA.
Abstract
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 coronal limb alignment. RESULTS: No pre-defined adverse events occurred and postoperative limb alignment more than ±3° from plan occurred in 11.2 % of cases. CONCLUSION: Active robotics for TKA is safe and effective as demonstrated in this trial.
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 coronal limb alignment. RESULTS: No pre-defined adverse events occurred and postoperative limb alignment more than ±3° from plan occurred in 11.2 % of cases. CONCLUSION: Active robotics for TKA is safe and effective as demonstrated in this trial.
Authors: Robert J Schoderbek; Thomas E Brown; Kevin J Mulhall; Varatharaj Mounasamy; Richard Iorio; Kenneth A Krackow; W Macaulay; Khaled J Saleh Journal: Clin Orthop Relat Res Date: 2006-05 Impact factor: 4.176
Authors: Kathi Thiele; Carsten Perka; Georg Matziolis; Hermann Otto Mayr; Michael Sostheim; Robert Hube Journal: J Bone Joint Surg Am Date: 2015-05-06 Impact factor: 5.284