O1166 COMPUTER ASSISTANCE DID NOT AFFECT THE 2-YEAR CLINICAL RESULTS OF SURGERY – AN RCT IN 100 LUMBAR FUSION PATIENTS

Abstract

Aims: Computer guidance has improved the accuracy and safety of pedicle screw insertion. The aim of this study was to evaluate whether CT-based computer assisted pedicle screw insertion enhances the clinical results of lumbar fusion. Methods: 100 lumbo- and thora-columbosacral operations were randomized either into i) conventional pedicle screw insertion (Group 1) or into ii) computer assisted technique using the SurgiGATE Spine 2.1 optoelectronic navigation system (Group 2). Clinical results were analyzed using the Oswestry index. Radiological analysis was performed by an independent radiologist. Results: 95 patients completed the follow-up. Three had died and two were lost. Thus, there were 48 patients (265 screws) in Group 1, 38 patients (201 screws) in Group 2, and 9 dropouts from the original randomization. There was no statistical difference between the groups regarding age, gender, diagnosis, type of operation, operating time or number of screws per patient. The follow-up time was 24.2 ± 1.6 months. The preoperative Oswestry score in Group 1 was 47.7 ± 16.6, and in Group 2 51.4 ± 16.3 (NS). The postoperative scores were, respectively, 27.1 ± 19.1 and 30.8 ± 22.7 (NS). The fusion rate in Group 1 was 85.1%, and in Group 2 92.1% (NS). In Group 1 4.5% of the screws were loose or broken as compared to 7.0% in Group 2 (NS). Conclusions: Despite superior accuracy, at 2-year follow-up no clinical benefit from computer assisted pedicle screw insertion could be demonstrated in this randomized controlled clinical study.