STUDY DESIGN: Two hundred-forty consecutive patients underwent laparoscopic instrumented interbody fusion using custom-designed instrumentation and BAK (Sulzer Spine Tech, Minneapolis, MN) fusion cages. The surgeries were performed at eight spine centers during U.S. Food and Drug Administration investigational device evaluation clinical trials. This cohort was compared with 591 consecutive patients undergoing open anterior fusion with the same device. OBJECTIVES: To investigate the feasibility and safety of the laparoscopic approach compared with that of open procedures. SUMMARY OF BACKGROUND DATA: In other areas of medicine, advances in laparoscopic surgical procedures have resulted in reduced morbidity, expense, and pain when compared with results of the open counterpart. METHODS: The open anterior procedure was performed using a retroperitoneal approach. The laparoscopic procedure was performed transperitoneally with carbon dioxide insufflation to provide visualization using a 10-mm endoscope. Two hollow, titanium, threaded interbody implants packed with autologous bone were inserted into the diseased interspace. RESULTS: The laparoscopy group had a shorter hospital stay and reduced blood loss but had increased operative time. Operative time improved in the laparoscopy group as surgeons' experience increased. Operative complications were comparable in both groups, with an occurrence of 4.2% in the open approach and 4.9% in the laparoscopic approach. Overall, the device-related reoperation rate was higher in the laparoscopy group (4.7% vs. 2.3%), primarily as a result of intraoperative disc herniation. Conversion to open procedure in the laparoscopy group was 10%, with most cases predictable and preventable. CONCLUSIONS: The laparoscopic procedure is associated with a learning curve, but once mastered, it is effective and safe when compared with open techniques of fusion.
STUDY DESIGN: Two hundred-forty consecutive patients underwent laparoscopic instrumented interbody fusion using custom-designed instrumentation and BAK (Sulzer Spine Tech, Minneapolis, MN) fusion cages. The surgeries were performed at eight spine centers during U.S. Food and Drug Administration investigational device evaluation clinical trials. This cohort was compared with 591 consecutive patients undergoing open anterior fusion with the same device. OBJECTIVES: To investigate the feasibility and safety of the laparoscopic approach compared with that of open procedures. SUMMARY OF BACKGROUND DATA: In other areas of medicine, advances in laparoscopic surgical procedures have resulted in reduced morbidity, expense, and pain when compared with results of the open counterpart. METHODS: The open anterior procedure was performed using a retroperitoneal approach. The laparoscopic procedure was performed transperitoneally with carbon dioxide insufflation to provide visualization using a 10-mm endoscope. Two hollow, titanium, threaded interbody implants packed with autologous bone were inserted into the diseased interspace. RESULTS: The laparoscopy group had a shorter hospital stay and reduced blood loss but had increased operative time. Operative time improved in the laparoscopy group as surgeons' experience increased. Operative complications were comparable in both groups, with an occurrence of 4.2% in the open approach and 4.9% in the laparoscopic approach. Overall, the device-related reoperation rate was higher in the laparoscopy group (4.7% vs. 2.3%), primarily as a result of intraoperative disc herniation. Conversion to open procedure in the laparoscopy group was 10%, with most cases predictable and preventable. CONCLUSIONS: The laparoscopic procedure is associated with a learning curve, but once mastered, it is effective and safe when compared with open techniques of fusion.