INTRODUCTION: The method of free-hand pedicle screw placement is generally safe although it carries potential risks. For this reason, several highly accurate computer-assisted systems were developed and are currently on the market. However, these devices have certain disadvantages. We have developed a method of pedicle screw placement in the lumbar and sacral region using a multi-level drill guide template, created with the rapid prototyping technology and have validated it in a clinical study. The aim of the study was to manufacture and evaluate the accuracy of a multi-level drill guide template for lumbar and first sacral pedicle screw placement and to compare it with the free-hand technique under fluoroscopy supervision. MATERIALS AND METHODS: In 2011 and 2012, a randomized clinical trial was performed on 20 patients. 54 screws were implanted in the trial group using templates and 54 in the control group using the fluoroscopy-supervised free-hand technique. Furthermore, applicability for the first sacral level was tested. Preoperative CT-scans were taken and templates were designed using the selective laser sintering method. Postoperative evaluation and statistical analysis of pedicle violation, displacement, screw length and deviation were performed for both groups. RESULTS: The incidence of cortex perforation was significantly reduced in the template group; likewise, the deviation and displacement level of screws in the sagittal plane. In both groups there was no significantly important difference in deviation and displacement level in the transversal plane as not in pedicle screw length. The results for the first sacral level resembled the main investigated group. CONCLUSIONS: The method significantly lowers the incidence of cortex perforation and is therefore potentially applicable in clinical practice, especially in some selected cases. The applied method, however, carries a potential for errors during manufacturing and practical usage and therefore still requires further improvements.
RCT Entities:
INTRODUCTION: The method of free-hand pedicle screw placement is generally safe although it carries potential risks. For this reason, several highly accurate computer-assisted systems were developed and are currently on the market. However, these devices have certain disadvantages. We have developed a method of pedicle screw placement in the lumbar and sacral region using a multi-level drill guide template, created with the rapid prototyping technology and have validated it in a clinical study. The aim of the study was to manufacture and evaluate the accuracy of a multi-level drill guide template for lumbar and first sacral pedicle screw placement and to compare it with the free-hand technique under fluoroscopy supervision. MATERIALS AND METHODS: In 2011 and 2012, a randomized clinical trial was performed on 20 patients. 54 screws were implanted in the trial group using templates and 54 in the control group using the fluoroscopy-supervised free-hand technique. Furthermore, applicability for the first sacral level was tested. Preoperative CT-scans were taken and templates were designed using the selective laser sintering method. Postoperative evaluation and statistical analysis of pedicle violation, displacement, screw length and deviation were performed for both groups. RESULTS: The incidence of cortex perforation was significantly reduced in the template group; likewise, the deviation and displacement level of screws in the sagittal plane. In both groups there was no significantly important difference in deviation and displacement level in the transversal plane as not in pedicle screw length. The results for the first sacral level resembled the main investigated group. CONCLUSIONS: The method significantly lowers the incidence of cortex perforation and is therefore potentially applicable in clinical practice, especially in some selected cases. The applied method, however, carries a potential for errors during manufacturing and practical usage and therefore still requires further improvements.
Authors: Ahmed A Aoude; Maryse Fortin; Rainer Figueiredo; Peter Jarzem; Jean Ouellet; Michael H Weber Journal: Eur Spine J Date: 2015-03-07 Impact factor: 3.134