A customized modular reference array clamp for navigated spine surgery

Introduction

The current authors have developed a modular system of reference array fixation which is tailored specifically to the spinal level being operated upon. They believe that this system may further increase the precision and accuracy of pedicle screw placement.

Materials and methods

Two formalin-fixed whole body cadavers were used for this study. For cervical spine evaluation of the reference clamp, four odontoid screws (two per cadaver) for C1/C2-fusion and four lateral mass screws (two per cadaver) were implanted. Following navigated screw placement with 2D and 3D fluoroscopic verification, insertion of two lateral mass screws was performed. In the same way, lumbar and thoracic pedicle screws were implanted. Two pedicle screws were placed at two levels of the lumbar and two levels of the thoracic areas giving an overall of 16 screws implanted (8 cervical, 4 thoracic, and 4 lumbar). Postoperative evaluation involved comparison of postoperative 3D scans and preoperative planning images. A simple classification system was used for evaluation of any deviation from the planned trajectory.

Results

All pedicle screw placements were performed as planned without any technical problems. The reference array clamps remained in position at all the spinal levels at which they were employed with no loosening or displacement and no secondary damage to any of the spinous processes. Manual manipulation was performed but no displacement or slippage was observed. Image artefacts caused by the reference clamp were not significant as to obscure the area of interest. Both imaging modalities (Iso-C 3D and Vario 3D) generated sufficiently precise 3D images. There was no substantial difference in quality when those two systems were compared.

Discussion

Insufficient fixation of the reference clamp can lead to failure and complications. To date, no reference clamp systems have been developed specifically for navigated spine surgery.

Conclusions

Stable reference array fixation is a critical step in navigated surgery. To date, the same reference clamps have been applied to the spinal anatomy as have been developed originally for the appendicular skeleton. The current investigators have developed a novel modular clamp and have demonstrated its efficacy in a cadaveric model.     

CT-navigation versus fluoroscopy-guided placement of pedicle screws at the thoracolumbar spine: single center experience of 4,500 screws

Purpose

Single center evaluation of the placement accuracy of thoracolumbar pedicle screws implanted either with fluoroscopy or under CT-navigation using 3D-reconstruction and intraoperative computed tomography control of the screw position. There is in fact a huge variation in the reported placement accuracy of pedicle screws, especially concerning the screw placement under conventional fluoroscopy most notably due to the lack of the definition of screw misplacement, combined with a potpourri of postinstrumentation evaluation methods.

Methods

The operation data of 1,006 patients operated on in our clinic between 1995 and 2005 is analyzed retrospectively. There were 2,422 screws placed with the help of CT-navigation compared to 2,002 screws placed under fluoroscopy. The postoperative computed tomography images were reviewed by a radiologist and an independent spine surgeon.

Results

In the lumbar spine, the placement accuracy was 96.4 % for CT-navigated screws and 93.9 % for pedicle screws placed under fluoroscopy, respectively. This difference in accuracy was statistically significant (Fishers Exact Test, p = 0.001). The difference in accuracy became more impressing in the thoracic spine, with a placement accuracy of 95.5 % in the CT-navigation group, compared to 79.0 % accuracy in the fluoroscopy group (p < 0.001).

Conclusion

This study underlines the relevance of CT-navigation-guided pedicle screw placement, especially when instrumentation of the middle and upper thoracic spine is carried out.     

Accuracy of percutaneous pedicle screws for thoracic and lumbar spine fractures: a prospective trial

Purpose

The percutaneous insertion technique requires surgical skill and experience. However, there have been few clinical reports evaluating the accuracy of minimally invasive pedicle screw placement using the conventional fluoroscopy method. The purpose of this study was to evaluate the accuracy of percutaneous pedicle screw placement in the treatment of thoracic and lumbar spine fractures using two-plane conventional fluoroscopy.

Methods

A prospective clinical trial was performed. A total of 502 percutaneous pedicle screws in 111 patients, all inserted with the assistance of conventional fluoroscopy, were evaluated. The safety and accuracy of pedicle screw placement were based on the evaluation of postoperative axial 3-mm slice computed tomography scans using the scoring system described by Zdichavsky et al. [Eur J Trauma 30:234–240, 2004; Eur J Trauma 30:241–247, 2004].

Results

427/502 pedicle screws (85 %) were classified as good and excellent concerning the best possible screw length and 494/502 (98 %) were found to have good or excellent position. One screw had to be revised due to medial position with a neurological deficit.

Conclusions

This study demonstrates the feasibility of placing percutaneous posterior thoracolumbar pedicle screws with the assistance of conventional fluoroscopy. Minimally invasive transpedicular instrumentation is an accurate, reliable and safe method to treat a variety of spinal disorders, including thoracic and lumbar spine fractures.     

Pedicle screw diameter selection for safe insertion in the thoracic spine

Objective

Many thoracic pedicles are too small for the safe acceptance of a transpedicular screw. However, few studies have so far reported on the methods to select a proper pedicle screw size and to confirm the morphologic changes for such a small thoracic spine pedicle. The objective of this work was to determine the potential limits of a pedicle screw diameter for transpedicular screw placement in the thoracic spine.

Methods

T2–T9 vertebrae from eleven patients that underwent posterior thoracic instrumentation with the use of fluoroscopically assisted insertion method were analyzed. The outcome measures were the pedicle widths, the gap between the outer pedicle width and the selected pedicle screw diameter, and the penetration length of the pedicle screws using computed tomography. The screws were distributed into two groups according to the pedicle width and screw diameter, and the screw perforation rate of the two groups was compared. The relationships of the gap and the distance of the screw penetration were compared and investigated in regard to the pedicle screw diameter selection.

Results

A total of 16 screws demonstrated a smaller diameter than the inner pedicle widths, while 22 screws had a larger diameter than the inner pedicle widths. One screw (6.3%) perforated the pedicle cortex in the smaller screw group, and twelve screws (54.5%) perforated the pedicle cortex in the larger screw group (P?=?0.006). A linear regression analysis in the larger screw group revealed that when the gap was less than 0.5?mm, a risk of a pedicle wall violation was observed.

Conclusions

When the screws with a larger diameter than the inner pedicle width are selected, the screw perforation rate increases. Therefore, the size of the screw diameter must be at least 0.5?mm less than the outer pedicle width to ensure safe transpedicular screw placement.     

Morphometry of the lower thoracic and lumbar pedicles and its relevance in pedicle fixation

Purpose

To assess the pedicle morphology in the lower thoracic and lumbar spine in an Indian population and to determine the causes of pedicle wall violation by pedicle screws.

Methods

Computerised tomographic scans of 135 consecutive patients with thoracolumbar and lumbar spine fractures were prospectively analysed to determine the pedicle morphology. The transverse pedicle angle, pedicle diameter and screw path length at 527 uninjured levels were measured. Post-operative CT scans of 117 patients were analysed to determine the accuracy of 468 pedicle screws at 234 vertebrae.

Results

The lowest (mean ± SD) transverse pedicle width in the lower thoracic spine was 5.4 ± 0.70 mm, whereas in the lumbar spine it was 7.2 ± 0.87 mm. The shortest (mean ± SD) screw path length in lower thoracic pedicles was 35.8 ± 2.10 and 41.9 ± 2.18 mm in the lumbar spine. The mean transverse pedicle angle in the lower thoracic spine was consistently less than 5°, whereas it gradually increased from L1 through L5 from 8.5° to 30°. Forty-one screws violated the pedicle wall, due to erroneous angle of screw insertion.

Conclusions

In the current study, pedicle dimensions were smaller compared to the Western population. In Indian patients, pedicle screws of 5 mm diameter and 30 mm length, and 6 mm diameter and 35 mm length can safely be used in the lower thoracic and lumbar spine, respectively. However, it is important to assess the pedicle morphology on imaging prior to pedicle fixation.

     

X-Ray assessment of the effect of pedicle screw on vertebra and spinal canal growth in children before the age of 7 years

Purpose

To determine the reliability of pedicle screws placed in children younger than 7 years of age, and to evaluate the effect of pedicle screw insertion on further growth of the vertebra and spinal canal.

Methods

A retrospective study of 35 consecutive patients through Jan 2003–Dec 2010 for congenital scoliosis in <7 years children was performed at one spine center. Patients undergoing pedicle screw instrumentation of at least two levels, which had been followed-up for at least 24 months were included. Measurements were performed in instrumented and adjacent non-instrumented levels. The effect of pedicle screw insertion on further growth was evaluated.

Results

The average age at surgery was 4.4 year (53 months, range, 23–84 months). 190 segments in 35 patients met the inclusion criteria. 77 segments had no screws and 113 had at least one screw. There was a significant difference between the pre-operative and final follow-up values of the measurement of spinal canal and vertebral body parameters (P < 0.001). No significant difference existed between growth rates of vertebral bodies and the sagittal diameters of spinal canal with or without screws. The growth rates of vertebral bodies in lumbar spine were higher than in thoracic spine in both instrumented and adjacent groups.

Conclusion

Pedicle screw instrumentation does not cause a retardation effect on the development of vertebral bodies and the spinal canal in children at an early age. It is a safe and reliable procedure to achieve a stable fixation.     

Reliability and consequences of intraoperative 3D imaging to control positions of thoracic pedicle screws

Introduction

The insertion of thoracic pedicle screws (T1–T10) is subject to a relevant rate of malplacement. The optimum implantation procedure is still a topic of controversial debate. Currently, a postoperative computed tomography is required to evaluate the screw positions. The present study was undertaken to clarify whether intraoperative 3D imaging is a reliable method of determining the position of thoracic pedicle screws.

Methods

This prospective study involved 40 consecutive patients with thoracic spinal injuries, with intraoperative 3D scans being performed to determine the positions of 240 pedicle screws in T1–T10. The results of the 3D scans were compared with the findings of postoperative CT scans, using a clinical classification system.

Results

The positions of 204 pedicle screws could be viewed by means of both 3D and CT scans and the results compared. The 3D scans achieved a sensitivity of 90.9?% and a specificity of 98.8?%. The rate of misclassification by the 3D scans was 2.5?%. Nine pedicle screws were classified as misplaced and their position corrected intraoperatively (3.8?%). No screws required postoperative revision.

Conclusions

Performing an intraoperative 3D scan enables the position of thoracic pedicle screws to be determined with sufficient accuracy. The rate of revision surgery was reduced to 0?%.     

Pullout strength of misplaced pedicle screws in the thoracic and lumbar vertebrae - A cadaveric study

Background:

The objective of this cadaveric study was to analyze the effects of iatrogenic pedicle perforations from screw misplacement on the mean pullout strength of lower thoracic and lumbar pedicle screws. We also investigated the effect of bone mineral density (BMD), diameter of pedicle screws, and the region of spine on the pullout strength of pedicle screws.

Materials and Methods:

Sixty fresh human cadaveric vertebrae (D10–L2) were harvested. Dual-energy X-ray absorptiometry (DEXA) scan of vertebrae was done for BMD. Titanium pedicle screws of different diameters (5.2 and 6.2 mm) were inserted in the thoracic and lumbar segments after dividing the specimens into three groups: a) standard pedicle screw (no cortical perforation); b) screw with medial cortical perforation; and c) screw with lateral cortical perforation. Finally, pullout load of pedicle screws was recorded using INSTRON Universal Testing Machine.

Results:

Compared with standard placement, medially misplaced screws had 9.4% greater mean pullout strength and laterally misplaced screws had 47.3% lesser mean pullout strength. The pullout strength of the 6.2 mm pedicle screws was 33% greater than that of the 5.2 mm pedicle screws. The pullout load of pedicle screws in lumbar vertebra was 13.9% greater than that in the thoracic vertebra (P = 0.105), but it was not statistically significant. There was no significant difference between pullout loads of vertebra with different BMD (P = 0.901).

Conclusion:

The mean pullout strength was less with lateral misplaced pedicle screws while medial misplaced pedicle screw had more pullout strength. The pullout load of 6.2 mm screws was greater than that of 5.2 mm pedicle screws. No significant correlation was found between bone mineral densities and the pullout strength of vertebra. Similarly, the pullout load of screw placed in thoracic and lumbar vertebrae was not significantly different.     

Accuracy of 3D fluoroscopy-navigated anterior transpedicular screw insertion in the cervical spine: an experimental study

Purpose

The technique of pedicle screw stabilization is finding increasing popularity for use in the cervical spine. Implementing anterior transpedicular screws (ATPS) in cervical spine offers theoretical advantages compared to posterior stabilization. The goal of the current study was the development of a new setting for navigated insertion of ATPS, combining the advantage of reduced invasiveness of an anterior approach with the technical advantages of navigation.

Methods

20 screws were implanted in levels C3 to C6 of four cervical spine models (SAWBONES^® Cervical Vertebrae with Anterior Ligament) with the use of 3D fluoroscopy navigation system [Arcadis Orbic 3D, Siemens and VectorVision fluoro 3D trauma software (BrainLAB)]. The accuracy of inserted screws was analyzed according to postoperative CT scans and following the modified Gertzbein and Robbins classification.

Results

20 anterior pedicle screws were placed in four human cervical spine models. Of these, eight screws were placed in C3, two screws in C4, six screws in C5, and four screws in C6. 16 of 20 screws (80 %) reached a grade 1 level of accuracy according to the modified Gertzbein and Robbins Classification. Three screws (15 %) were grade 2, and one screw (5 %) was grade 3. Grade 4 and 5 positions were not evident. Summing grades 1 and 2 together as “good” positions, 95 % of the screws achieved this level. Only a single screw did not fulfill these criteria.

Conclusion

The setting introduced in this study for navigated insertion of ATPS into cervical spine bone models is well implemented and shows excellent results, with an accuracy of 95 % (Gertzbein and Robbins grade 2 or better). Thus, this preliminary study represents a prelude to larger studies with larger case numbers on human specimens.

     

Which posterior instrumentation is better for two-level anterior lumbar interbody fusion: translaminar facet screw or pedicle screw?

Purpose

To determine whether translaminar facet screws can provide stability equivalent to pedicle screws and whether the two posterior instrumentations have the same influence on the adjacent segments in two-level anterior lumbar interbody fusion.

Methods

In a biomechanical study conducted, we used 12 fresh human lumbar spines and tested an intact spine with a stand-alone two-level anterior lumbar interbody fusion and anterior fusion augmented with pedicle screws or translaminar facet screws, under 400 N compressive preloads and 7.5 N m moments in flexion, extension, axial rotation and lateral bending, and measured the stiffness of the operated level, range of motion and intradiscal pressure at the adjacent levels.

Results

We found a significant increase in the stiffness of the segments operated, range of motion and intradiscal pressure at the adjacent superior segment in the stand-alone two-level anterior lumbar interbody fusion during flexion, axial rotation and lateral bending, but a decrease in extension, when compared with the intact spine. The stiffness of operated segments, range of motion and intradiscal pressure in the adjacent segment are significantly higher in the two-level anterior lumbar interbody fusion augmented with posterior instrumentation than in the stand-alone two-level anterior lumbar interbody fusion. There was no significant difference between the two augmented constructs except that, at the adjacent superior segment, the intradiscal pressure was more in the construction augmented with a pedicle screw than with a translaminar facet screw in flexion.

Conclusions

Translaminar facet screws can provide stability equivalent to pedicle screws, but their influence on the adjacent segments is relatively lower; therefore, we suggest that translaminar facet screws be the choice in the optimal posterior instrumentation in a two-level anterior lumbar interbody fusion.     

Biomechanical comparison of sagittal-parallel versus non-parallel pedicle screw placement

Background

While convergent placement of pedicle screws in the axial plane is known to be more advantageous biomechanically, surgeons intuitively aim toward a parallel placement of screws in the sagittal plane. It is however not clear whether parallel placement of screws in the sagittal plane is biomechanically superior to a non-parallel construct. The hypothesis of this study is that sagittal non-parallel pedicle screws do not have an inferior initial pull-out strength compared to parallel placed screws.

Methods

The established lumbar calf spine model was used for determination of pull-out strength in parallel and non-parallel intersegmental pedicle screw constructs. Each of six lumbar calf spines (L1-L6) was divided into three levels: L1/L2, L3/L4 and L5/L6. Each segment was randomly instrumented with pedicle screws (6/45 mm) with either the standard technique of sagittal parallel or non-parallel screw placement, respectively, under fluoroscopic control. CT was used to verify the intrapedicular positioning of all screws. The maximum pull-out forces and type of failure were registered and compared between the groups.

Results

The pull-out forces were 5,394 N (range 4,221 N to 8,342 N) for the sagittal non-parallel screws and 5,263 N (range 3,589 N to 7,554 N) for the sagittal-parallel screws (p?=?0.838). Interlevel comparisons also showed no statistically significant differences between the groups with no relevant difference in failure mode.

Conclusion

Non-parallel pedicle screws in the sagittal plane have at least equal initial fixation strength compared to parallel pedicle screws in the setting of the here performed cadaveric calf spine experiments.     

A CT-based study investigating the relationship between pedicle screw placement and stimulation threshold of compound muscle action potentials measured by intraoperative neurophysiological monitoring

Purpose

Neurophysiological monitoring aims to improve the safety of pedicle screw placement, but few quantitative studies assess specificity and sensitivity. In this study, screw placement within the pedicle is measured (post-op CT scan, horizontal and vertical distance from the screw edge to the surface of the pedicle) and correlated with intraoperative neurophysiological stimulation thresholds.

Methods

A single surgeon placed 68 thoracic and 136 lumbar screws in 30 consecutive patients during instrumented fusion under EMG control. The female to male ratio was 1.6 and the average age was 61.3 years (SD 17.7). Radiological measurements, blinded to stimulation threshold, were done on reformatted CT reconstructions using OsiriX software. A standard deviation of the screw position of 2.8 mm was determined from pilot measurements, and a 1 mm of screw—pedicle edge distance was considered as a difference of interest (standardised difference of 0.35) leading to a power of the study of 75 % (significance level 0.05).

Results

Correct placement and stimulation thresholds above 10 mA were found in 71 % of screws. Twenty-two percent of screws caused cortical breach, 80 % of these had stimulation thresholds above 10 mA (sensitivity 20 %, specificity 90 %). True prediction of correct position of the screw was more frequent for lumbar than for thoracic screws.

Conclusion

A screw stimulation threshold of >10 mA does not indicate correct pedicle screw placement. A hypothesised gradual decrease of screw stimulation thresholds was not observed as screw placement approaches the nerve root. Aside from a robust threshold of 2 mA indicating direct contact with nervous tissue, a secondary threshold appears to depend on patients’ pathology and surgical conditions.     

Prospective comparative study between straight and curved probe for pedicle screw insertion

Purpose

To evaluate difference in accuracy of pedicle screw insertion in thoracic and lumbosacral spine using a straight pedicle probe vis-à-vis a curved one.

Methods

Prospective, comparative, non-randomized, single-blind study. Straight and curved pedicle probes used on opposite sides of same vertebra in patients undergoing thoracolumbar pedicle screw fixation for various indications. Postoperative blinded evaluation for pedicle breaches done with a CT scan. Pedicle breaches graded as grade 0: no breach, grade 1: <2 mm, grade 2: 2–4 mm and grade 3: >4 mm breach.

Results

After appropriate statistical power analysis, 300 screws inserted in 59 patients from T4–L5 levels. No significant differences noted between the two probes in terms of screw length [two-tailed p = 0.16]; grade 0 screws [two-tailed p = 0.49] or screws with grade 2/3 breaches [two-tailed  p = 0.68]. With the right-hand-dominant operating-surgeon standing to left of patient during surgery, no difference noted between the two probes for either the right or left-side pedicle screw insertion [two-tailed p = 1]. Repeating these tests in the subset of thoracic pedicle screws too, revealed no significant difference.

Conclusions

No significant difference in outcome of pedicle screw insertion with either a straight or a curved pedicle probe.     

Accuracy of patient-specific template-guided vs. free-hand fluoroscopically controlled pedicle screw placement in the thoracic and lumbar spine: a randomized cadaveric study

Purpose

Dorsal spinal instrumentation with pedicle screw constructs is considered the gold standard for numerous spinal pathologies. Screw misplacement is biomechanically disadvantageous and may create severe complications. The aim of this study was to assess the accuracy of patient-specific template-guided pedicle screw placement in the thoracic and lumbar spine compared to the free-hand technique with fluoroscopy.

Methods

Patient-specific targeting guides were used for pedicle screw placement from Th2–L5 in three cadaveric specimens by three surgeons with different experience levels. Instrumentation for each side and level was randomized (template-guided vs. free-hand). Accuracy was assessed by computed tomography (CT), considering perforations of <2 mm as acceptable (safe zone). Time efficiency, radiation exposure and dependencies on surgical experience were compared between the two techniques.

Results

96 screws were inserted with an equal distribution of 48 screws (50 %) in each group. 58 % (n = 28) of template-guided (without fluoroscopy) vs. 44 % (n = 21) of free-hand screws (with fluoroscopy) were fully contained within the pedicle (p = 0.153). 97.9 % (n = 47) of template-guided vs. 81.3 % (n = 39) of free-hand screws were within the 2 mm safe zone (p = 0.008). The mean time for instrumentation per level was 01:14 ± 00:37 for the template-guided vs. 01:40 ± 00:59 min for the free-hand technique (p = 0.013), respectively. Increased radiation exposure was highly associated with lesser experience of the surgeon with the free-hand technique.

Conclusions

In a cadaver model, template-guided pedicle screw placement is faster considering intraoperative instrumentation time, has a higher accuracy particularly in the thoracic spine and creates less intraoperative radiation exposure compared to the free-hand technique.

     

Accuracy and safety of free-hand pedicle screw fixation in age less than 10 years

Background:

Pedicle screws are being used commonly in the treatment of various spinal disorders. However, use of pedicle screws in the pediatric population is not routinely recommended because of the risk of complications. The present study was to evaluate the safety of pedicle screws placed in children aged less than 10 years with spinal deformities and to determine the accuracy and complication (early and late) of pedicle screw placement using the postoperative computed tomography (CT) scans.

Materials and Methods:

Thirty one patients (11 males and 20 females) who underwent 261 pedicle screw fixations (177 in thoracic vertebrae and 84 in lumbar vertebrae) for a variety of pediatric spinal deformities at a single institution were included in the study. The average age of patients was 7 years and 10 months. These patients underwent postoperative CT scan which was assessed by two independent observers (spine surgeons) not involved in the treatment.

Results:

Breach rate was 5.4% (14/261 screws) for all pedicles. Of the 177 screws placed in the thoracic spine, 13 (7.3%) had breached the pedicle, that is 92.7% of the screws were accurately placed within pedicles. Seven screws (4%) had breached the medial pedicle wall, 4 screws (2.3%) had breached the lateral pedicle wall and 2 screws (1.1%) had breached the superior or inferior pedicle wall respectively. Of the 84 screws placed in the lumbar spine, 83 (98.8%) screws were accurately placed within the pedicle. Only 1 screw (1.2%) was found to be laterally displaced. In addition, the breach rate was found to be 4.2% (11/261 screws) with respect to the vertebral bodies. No neurological, vascular or visceral complications were encountered.

Conclusions:

The accuracy of pedicle screw placement in pedicles and vertebral bodies were 94.6% and 95.8% respectively and there was no complication related to screw placement noted until the last followup. These results suggest that free-hand pedicle screw fixation can be safely used in patients younger than 10 years to treat a variety of spinal disorders.     

Posterior-only correction of Scheuermann kyphosis using pedicle screws: economical optimization through screw density reduction

Introduction

Posterior-only approach using pedicle screws’ fixation has emerged as the preferred surgical technique for Scheuermann kyphosis (SK) correction. Insertion of multiple pedicle screws while increasing stability increases also the risk of complications related to screw malpositioning and surgical cost. The optimal screw density required in surgical correction of SK remains unclear. This study compares the safety and efficacy of low screw density (LSD) versus high screw density (HSD) technique used in posterior-only correction of SK.

Methods

Twenty-one patients underwent surgical correction of SK between 2007 and 2011 and were reviewed after a mean of 29 months. HSD technique (i.e., 100 % of available pedicles, averaged 25.2 ± 4 screws) was used in 10 cases and LSD technique (i.e., 54–69 % of available pedicles in a pre-determined pattern, averaged 16.8 ± 1.3 screws; p < 0.001) was used in 11 cases. Kyphosis correction was assessed by comparing thoracic kyphosis, lumbar lordosis and sagittal balance on preoperative and postoperative radiographs. Cost saving analysis was performed for each group.

Results

Preoperative thoracic kyphosis, lumbar lordosis and sagittal balance were similar for both groups. The average postoperative kyphosis correction was similar in both HSD and LSD groups (29° ± 9° vs. 34° ± 6°, respectively; p = 0.14). Complication occurred in four patients (19 %) in the HSD group and in two patients (9 %) in the LSD group (p = 0.56). Three patients required re-operation. Compared to HSD using LSD saves 4,200£ per patient in hardware and 88,200£ for the entire cohort.

Conclusion

LSD technique is as safe and effective as HSD technique in posterior-only correction of SK. Implant-related cost could be reduced by 32 %.     

A multi-level rapid prototyping drill guide template reduces the perforation risk of pedicle screw placement in the lumbar and sacral spine

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.     

Robot-assisted and fluoroscopy-guided pedicle screw placement: a systematic review

Purpose

At present, most spinal surgeons undertake pedicle screw implantation using either anatomical landmarks or C-arm fluoroscopy. Reported rates of screw malposition using these techniques vary considerably, though the evidence generally favors the use of image-guidance systems. A miniature spine-mounted robot has recently been developed to further improve the accuracy of pedicle screw placement. In this systematic review, we critically appraise the perceived benefits of robot-assisted pedicle screw placement compared to conventional fluoroscopy-guided technique.

Methods

The Cochrane Central Register of Controlled Trials, PubMed, and EMBASE databases were searched between January 2006 and January 2013 to identify relevant publications that (1) featured placement of pedicle screws, (2) compared robot-assisted and fluoroscopy-guided surgery, (3) assessed outcome in terms of pedicle screw position, and (4) present sufficient data in each arm to enable meaningful comparison (>10 pedicle screws in each study group).

Results

A total of 246 articles were retrieved, of which 5 articles met inclusion criteria, collectively reporting placement of 1,308 pedicle screws (729 robot-assisted, 579 fluoroscopy-guided). The findings of these studies are mixed, with limited higher level of evidence data favoring fluoroscopy-guided procedures, and remaining comparative studies supporting robot-assisted pedicle screw placement.

Conclusions

There is insufficient evidence to unequivocally recommend one surgical technique over the other. Given the high cost of robotic systems, and the high risk of spinal surgery, further high quality studies are required to address unresolved clinical equipoise in this field.