Catastrophic acute failure of pelvic fixation in adult spinal deformity requiring revision surgery: a multicenter review of incidence, failure mechanisms, and risk factors.

OBJECTIVE: There are few prior reports of acute pelvic instrumentation failure in spinal deformity surgery. The objective of this study was to determine if a previously identified mechanism and rate of pelvic fixation failure were present across multiple institutions, and to determine risk factors for these types of failures. METHODS: Thirteen academic medical centers performed a retrospective review of 18 months of consecutive adult spinal fusions extending 3 or more levels, which included new pelvic screws at the time of surgery. Acute pelvic fixation failure was defined as occurring within 6 months of the index surgery and requiring surgical revision. RESULTS: Failure occurred in 37 (5%) of 779 cases and consisted of either slippage of the rods or displacement of the set screws from the screw tulip head (17 cases), screw shaft fracture (9 cases), screw loosening (9 cases), and/or resultant kyphotic fracture of the sacrum (6 cases). Revision strategies involved new pelvic fixation and/or multiple rod constructs. Six patients (16%) who underwent revision with fewer than 4 rods to the pelvis sustained a second acute failure, but no secondary failures occurred when at least 4 rods were used. In the univariate analysis, the magnitude of surgical correction was higher in the failure cohort (higher preoperative T1-pelvic angle [T1PA], presence of a 3-column osteotomy; p < 0.05). Uncorrected postoperative deformity increased failure risk (pelvic incidence-lumbar lordosis mismatch > 10°, higher postoperative T1PA; p < 0.05). Use of pelvic screws less than 8.5 mm in diameter also increased the likelihood of failure (p < 0.05). In the multivariate analysis, a larger preoperative global deformity as measured by T1PA was associated with failure, male patients were more likely to experience failure than female patients, and there was a strong association with implant manufacturer (p < 0.05). Anterior column support with an L5-S1 interbody fusion was protective against failure (p < 0.05). CONCLUSIONS: Acute catastrophic failures involved large-magnitude surgical corrections and likely resulted from high mechanical strain on the pelvic instrumentation. Patients with large corrections may benefit from anterior structural support placed at the most caudal motion segment and multiple rods connecting to more than 2 pelvic fixation points. If failure occurs, salvage with a minimum of 4 rods and 4 pelvic fixation points can be successful.

Robotic-Assisted Revision Spine Surgery.

As the surgical treatment of spinal degenerative conditions increases, more patients will ultimately require revision spine surgery. Revision spine surgery is more technically demanding than primary surgery with increased complication rates and variable clinical outcomes. The freehand placement of pedicle screws into a previously operated and/or fused level is more difficult due to the altered anatomic landmarks and/or bone loss. Additional benefit of robotic spine surgery is appreciated during such revision spine surgical procedures with unusual anatomic considerations, whereby the preoperative planning using robotic planning software and computer-assisted robotic guidance play a crucial role in assisting the surgeon to "visualize the invisible." We highlight 3 roles of this technology in 3 cases: planning strategic osteotomies, redrilling of screw holes, and insertion of revision screws in previously operated thoracolumbar and cervical spine regions.

Can Robotic Spine Surgery Become the Standard of Care?

Concerns regarding traditional techniques led to the development of robotic systems to facilitate the safe and accurate placement of pedicle screws. The Mazor Spine Assist was the first robotic spine surgery (RSS) platform to receive US Food and Drug Administration approval in 2004. Since then, there has been a steady increase in the application of RSS with several additional iterations of the Mazor platform and other competing systems receiving approval. As the indications, potential benefits, and utilization of RSS continue to expand, the question naturally arises as to whether RSS will eventually become the standard of care for spine surgery. In this article, we review the available evidence and experience with RSS and discuss the potential for RSS to become the medical standard of care.

Robotic Spine Surgery: Past, Present, and Future.

STUDY DESIGN: Systematic review. OBJECTIVE: The aim of this review is to present an overview of robotic spine surgery (RSS) including its history, applications, limitations, and future directions. SUMMARY OF BACKGROUND DATA: The first RSS platform received United States Food and Drug Administration approval in 2004. Since then, robotic-assisted placement of thoracolumbar pedicle screws has been extensively studied. More recently, expanded applications of RSS have been introduced and evaluated. METHODS: A systematic search of the Cochrane, OVID-MEDLINE, and PubMed databases was performed for articles relevant to robotic spine surgery. Institutional review board approval was not needed. RESULTS: The placement of thoracolumbar pedicle screws using RSS is safe and accurate and results in reduced radiation exposure for the surgeon and surgical team. Barriers to utilization exist including learning curve and large capital costs. Additional applications involving minimally invasive techniques, cervical pedicle screws, and deformity correction have emerged. CONCLUSION: Interest in RSS continues to grow as the applications advance in parallel with image guidance systems and minimally invasive techniques. IRB APPROVAL: N/A.

Robotic-guided placement of cervical pedicle screws: feasibility and accuracy.

INTRODUCTION: It has been shown that pedicle screw instrumentation in the cervical spine has superior biomechanical pullout strength and stability. However, due to the complex and variable anatomy of the cervical pedicles and the risk of catastrophic complications, cervical pedicle screw placement is not widely utilized. STUDY DESIGN: A retrospective, consecutive patient review. OBJECTIVE: To review and report our experience with robotic guided cervical pedicle screw placement. METHODS: We retrospectively reviewed preoperative and postoperative CT scans of 12 consecutive patients who underwent cervical pedicle screw fixation with robotic guidance. Screw placement and deviation from the preoperative plan were assessed using the robotic system's planning software by fusing the preoperative CT (with the planned cervical pedicle screws) to the post-op CT. This process was carried out by manually aligning the anatomical landmarks on the two CTs. Once a satisfactory fusion was achieved, the software's measurement tool was used manually to compare the planned vs. actual screw placements in the axial, sagittal and coronal planes within the instrumented pedicle in a resolution of 0.1 mm. Medical charts were reviewed for technical issues and intra-operative complications. RESULTS: Eighty-eight cervical pedicle screws were reviewed in 12 patients; mean age = 65 years, M:F = 2:1, and mean BMI = 27.99. No intra-operative complications related to the cervical pedicle screw placement were reported. Robotic guidance was successful in all 88 screws: eight in C2, 14 in C3, 16 in each of C4 and C5, 19 in C6, and 15 at C7. There were 14 pedicle screw breaches (15.9%); all were medial, less than 1 mm, and with no clinical consequences. In the axial plane, the screws deviated from the preoperative plan by 1.32 ± 1.17 mm and in the sagittal plane by 1.27 ± 1.00 mm. In the trajectory view, the overall deviation was 2.20 ± 1.17 mm. Although differences were observed in screw deviation from the pre-op plan between the right and left sides, they were not statistically significant (p > 0.05). CONCLUSION: This study indicates that robotic-guided cervical pedicle screw placement is feasible and safe. The medial breaches did not result in any clinical consequences.

Minimally Invasive Robotic Lumbar Facet Decortication.

Minimally invasive percutaneous pedicle screws (PPS) are placed through muscle sparing paramedian incisions and provide rigid 3 column fixation to promote stability and fusion. Percutaneous pedicle instrumentation is generally performed as adjunctive posterior stabilization after anterior lumbar interbody fusion or lateral lumbar interbody fusion procedures. In these instances, arthrodesis is often achieved through the interbody fusion rather than posterior column fusion. In some cases, the surgeon may choose to perform posterior facet fusion in addition to PPS and anterior interbody. The addition of a minimally invasive facet fusion to PPS and anterior column interbody fusion creates more fusion surface and enables a truly circumferential fusion. While robotic-guided facet decortication has been suggested, there are currently no published techniques. Here, we describe a novel minimally invasive technique to perform percutaneous robotic facet decortication in conjunction with PPS following anterior lumbar interbody fusion or lateral lumbar interbody fusion.

The predictive accuracy of surgical planning using pre-op planning software and a robotic guidance system.

BACKGROUND: Navigation and robotic-guided systems are being used more often to facilitate efficient and accurate placement of hardware during spinal surgeries. Preoperative surgical planning is a key step in the safe use of these tools. No studies have yet investigated the predictive accuracy of surgical planning using a robotic guidance system. METHODS: Data were prospectively collected from patients in whom Mazor X-Align ™ [Medtronic Inc., Minneapolis, MN., USA] robotic guidance system software was used to plan their spinal instrumentation in order to achieve the best possible correction and the plans executed intraoperatively under robotic guidance. RESULTS: A total of 33 patients (26 females, 7 males) were included. Their mean age was 51 years (12-79), and their mean BMI was 23.90 (15.55-35.91). Their primary diagnoses were scoliosis (20), kyphosis (5), spondylolisthesis (4), adjacent segment degeneration (3), and metastatic tumor (1). Preoperatively, the patients' mean coronal Cobb Angle (CA) was 36.5 ± 14.4°, and their mean sagittal CA was 27.7 ± 20.0°. The mean planned correction coronal CA was 0.2 ± 1.2°, and the mean planned correction sagittal CA was 28.4 ± 16.7°. Postoperatively, the patients' mean coronal CA that was achieved was 5.8 ± 7.4°, and their mean sagittal CA was 31.0 ± 18.3°. The mean difference between the planned and achieved angles was 5.5 ± 7.4° for the coronal, and 9.03 ± 9.01° for the sagittal CA. For the thoracic kyphosis and lumbar lordosis, the mean difference between the planned and postoperatively measured values was 15.3 ± 10.8 and 12.8 ± 9.6, respectively. CONCLUSION: This study indicates that the predictive accuracy of the use of preoperative planning software and robotic guidance to facilitate the surgical plan is within 6° and 9° in the coronal and sagittal planes, respectively.

Representative dynamic ranges of spinal alignment during gait in patients with mild and severe adult spinal deformities.

BACKGROUND CONTEXT: Surgical correction strategies for adult spinal deformity (ASD) relies heavily on radiographic alignment goals, however, there is often debate regarding degree of correction and how static alignment translates to physical ability in daily life. Kinematic analysis has the potential to improve the concept of ideal spinal alignment by providing clinically meaningful estimates of dynamic changes in spinal alignment during activities of daily life. PURPOSE: Estimate representative dynamic ranges of spinal alignment during gait among ASD patients using 3D motion tracking; compare dynamic alignment between mild and severe deformity patients and to healthy adults. STUDY DESIGN/SETTING: Retrospective review at a single institution. PATIENT SAMPLE: Fifty-two ASD patients and 46 healthy adults. OUTCOME MEASURES: Radiographic alignment, kinematic spine motion, spatiotemporal gait measures, patient reported outcomes (VAS pain, ODI, SRS-22r). METHODS: Spinal alignment was assessed radiographically and during standing and overground walking tests. Dynamic alignment was initialized by linking radiographic alignment to kinematic alignment during standing and at initial heel contact during gait. Dynamic changes in maximums and minimums during gait were made relative to initial heel contact for each gait cycle. Total range-of-motion (RoM) was measured for both ASD and healthy subjects. Dynamic alignment measures included coronal and sagittal vertical axes (CVA, SVA), T1 pelvic angle (TPA), lumbar lordosis (LL), and pelvic tilt (PT). ASD patient's deformities were classified as either Mild or Severe based on the SRS-Schwab ASD classification. RESULTS: Severe ASD patients had significantly larger dynamic maximum and minimums for SVA, TPA, LL, and PT (all p<.05) compared with Mild ASD patients. ASD patients exhibited little difference in dynamic alignment compared with healthy subjects. Only PT had a significant difference in dynamic RoM compared with healthy (p<.001). CONCLUSIONS: Mild and Severe ASD patients exhibited similar global dynamic alignment measures during gait and had comparable RoM to healthy subjects except with greater PT and reduced spatiotemporal performance which may be key compensatory mechanisms for dynamic stabilization.

Robotic-Assisted Pedicle Screw Placement During Spine Surgery.

Preoperative planning software and a robotic device facilitate the placement of pedicle screws, especially in patients with difficult anatomy, thereby increasing the feasibility, accuracy, and efficiency of the procedure. The robot functions as a semiactive surgical assistive device whose goal is not to substitute but to offer the surgeon a set of versatile tools that can broaden his or her ability to treat patients1. DESCRIPTION: The robotic guidance system consists of a bed-mounted surgical arm and a workstation. We used the Mazor X Stealth Edition Robotic Guidance System by Medtronic for spine surgery, which has been previously described2-5. Unlike other systems that are navigation-based and require an optical tracking mechanism, this system relies on the preoperative plan to be referenced using the intraoperative registration. The workstation runs an interface software that facilitates preoperative planning, intraoperative image acquisition and registration, kinematic calculations, and real-time robot motion control. The robotic arm is mounted onto the bed as well as rigidly attached to the patient's spine. It can move in 6 degrees of freedom to provide the preplanned screw trajectory and entry point thereby allowing the surgeon to manually perform the drilling and screw insertion through either an open or percutaneous procedure by first seating a drill tube and then drilling and tapping the hole as needed. ALTERNATIVES: Other robotic systems include the ROSA robot by Medtech, the ExcelsiusGPS robot by Globus Medical, and the SurgiBot and ALF-X Surgical Robotic systems (both from TransEnterix). The Da Vinci Surgical System (Intuitive Surgical) has been utilized for laparoscopic anterior lumbar interbody fusion (ALIF), but it has not been approved by the U.S. Food and Drug Administration for actual spinal instrumentation. Alternative surgical techniques for pedicle screw placement include the freehand fluoroscopy-guided technique and intraoperative image-assisted computer navigation techniques, including isocentric C-arm (Iso-C) 3D (3-dimensional) navigation (Siemens), computed tomography (CT) navigation, O-arm navigation (Medtronic), CT-magnetic resonance imaging co-registration technology, and a 3D-visual guidance technique6-8. RATIONALE: The robotic-guided pedicle screw placement offers the following benefits over conventional dorsal instrumentation techniques: improved accuracy and safety in pedicle screw insertion2-4,9-13; precision in screw size selection and planned screw positioning2; a reduction in exposure to radiation for the surgeon, the patient, and the operating-room staff9,11,12,14-19; simplicity and user-friendliness with a moderate learning curve10,11,20,21; ease of registration and reduction of operating time2; significant enhancement of the surgeon's ergonomics and dexterity for repetitive tasks in pedicle screw placement15,22-24; and a wider coverage in function to include utilization during minimally invasive surgery where applicable11,25. EXPECTED OUTCOMES: Accuracy rates between 94.5% and 99%, comparable with those in our study10, have been reported with the robotic-guided pedicle screw insertion technique, even in studies involving complex deformities and revision surgeries for congenital malformations, degenerative disorders, destructive tumors, and trauma2-4,9-13. The safety of this technique, in terms of reduced complications and intraoperative radiation exposure, has also been documented as higher than that for freehand fluoroscopic guidance or other navigation techniques9,11,12,14-19. The feasibility of this procedure has been further extended to minimally invasive procedures and to use in the cervical region, with replication of its advantages. It is associated with a reasonable learning curve, with consistent successful results after 25 to 30 patients. IMPORTANT TIPS: The principles of robotic-guided pedicle screw placement are similar irrespective of the system used.Although initially utilized mainly for thoracolumbar pedicle screw insertion, the latest robots and software have been adapted for use in the cervical spine with equivalent efficiency and accuracy.Robotic guidance can be employed in non-pedicle-screw-insertion procedures.Challenges include radiation exposure, trajectory failure, equipment and software failure, failed registration, logistics, time, and high cost.

Does improved radiographic alignment truly enhance dynamic functional balance?

STUDY DESIGN: Prospective concurrent cohort study. OBJECTIVE: To establish the relationship between radiographic alignment parameters and functional CoE measurements at 1 week before and at 3 months after realignment surgery in ADS patients. Adult degenerative scoliosis (ADS) represents a significant healthcare burden with exceedingly high and increasing prevalence, particularly among the elderly. Radiographic alignment measures and patient-reported outcomes currently serve as the standard means to assess spinal alignment, deformity, and stability. Neurological examinations have served as qualitative measures for indicating muscle strength, motor deficits, and gait abnormalities. Three-dimensional motion analysis is increasingly being used to identify and measure gait and balance instability. Recently, techniques have been established to quantify balance characteristics described by Dubousset as the "cone of economy" (CoE). The relationship between radiographic alignment parameters and CoE balance measures of ADS patients before and after realignment surgery is currently unknown. PATIENT SAMPLE: 29 ADS patients treated with realignment surgery. METHODS: Patients were evaluated at 1 week before realignment surgery and at their 3-month follow-up examination. During each evaluation, patients completed self-reported outcomes (visual analog scales for pain, Oswestry Disability Index, SRS22r) and a functional balance test. Mean changes in dependent measures from before to after surgery were compared using paired t tests. Pearson correlations were used to test for significant correlations between changes in radiographic and CoE measures. RESULTS: Significant improvements were found for all patient-reported outcomes, in several radiographic measures, and in CoE measures. Improvements of scoliosis Cobb angle, coronal pelvic tilt, lumbar lordosis, and thoracic kyphosis showed significant correlations with CoE sway and total distance measures at both the center of mass and center of the head. CONCLUSION: Improved radiographic alignment measures significantly correlated with improved CoE balance measures among ADS patients treated with realignment surgery at their three-month follow-up. These findings indicate that functional balance evaluations when used in conjunction with radiographic measurements, may provide a more robust and improved patient-specific sensitivity for postoperative assessments. CoE balance may represent a new measure of added value for surgical intervention of ADS.