Basis for error in stereotactic and computer-assisted surgery in neurosurgical applications: literature review.

Technological advancements in optoelectronic motion capture systems have allowed for the development of high-precision computer-assisted surgery (CAS) used in cranial and spinal surgical procedures. Errors generated sequentially throughout the chain of components of CAS may have cumulative effect on the accuracy of implant and instrumentation placement - potentially affecting patient outcomes. Navigational integrity and maintenance of fidelity of optoelectronic data is the cornerstone of CAS. Error reporting measures vary between studies. Understanding error generation, mechanisms of propagation, and how they relate to workflow can assist clinicians in error mitigation and improve accuracy during navigation in neurosurgical procedures. Diligence in planning, fiducial positioning, system registration, and intra-operative workflow have the potential to improve accuracy and decrease disparity between planned and final instrumentation and implant position. This study reviews the potential errors associated with each step in computer-assisted surgery and provides a basis for disparity in intrinsic accuracy versus achieved accuracy in the clinical operative environment.

Comparative in vitro biomechanical analysis of a novel posterior cervical fixation technique versus conventional posterior-based constructs.

STUDY DESIGN: Comparative in vitro, cadaveric biomechanical study. OBJECTIVE: To compare the kinematic response of a new posterior cervical midline surgical technique versus that of conventional fixation techniques. SUMMARY OF BACKGROUND DATA: A new method was designed using alternating bilateral intralaminar screws connected with a single midline rod. This technique provides the theoretical benefits of less operative dissection and reduced implant cost, but the acute flexibility properties remain unknown. Using an in vitro cadaveric model, the study objective was to define the operative level(s) changes in multidirectional flexibility after posterior destabilization/reconstruction from C3 to C6. METHODS: A 6 degree of freedom spine stimulator was used to test flexibility in 7 human cadaveric specimens. Flexion-extension, lateral bending, and axial rotation were tested in the intact condition, followed by destabilization by a simulated posterior column injury from C3 to C6. Specimens were then reconstructed from C3 to C6 and tested in the following sequence: sublaminar hook rod (SH), lateral mass screw rod (LMR), midline laminectomy from C3 to C6 with LMR (MLR), and midline posterior fixation from C3 to C6 (SMF). Range of motion (ROM) and neutral zone were quantified and analyzed. RESULTS: Significant increases in ROM and neutral zone at C3 to C6 were found under all loading conditions for the destabilized condition and intact spine versus all other treatments (P<0.05). The conventional treatments: SH, LMR, and MLR resulted in significantly less ROM than the proposed SMF in flexion-extension and lateral bending (P<0.05). Axial rotation provided similar results; however, no differences were observed between the SH and SMF (P>0.05). Notably, LMR and MLR provided significantly more stability than SH in axial rotation (P<0.05). CONCLUSIONS: Data produced suggest that the new, midline rod fixation approach provides less biomechanical stability than conventional posterior cervical reconstruction techniques. In addition, the high incidence of laminar fracture during screw placement and close proximity of the screw trajectory and polyaxial heads to the dura suggest a practical limitation as well.

Biomechanical Analysis of 2 Versus 4 Rods Across the Cervicothoracic Junction in a Human Cadaveric Model.

BACKGROUND AND OBJECTIVES: Posterior reconstruction of the cervicothoracic junction poses significant biomechanical challenges secondary to transition from the mobile cervical to rigid thoracic spines and change in alignment from lordosis to kyphosis. After destabilization, the objectives of the current investigation were to compare the rod strain and multidirectional flexibility properties of the cervicothoracic junction using a 4-rod vs traditional 2-rod reconstructions. METHODS: Ten human cadaveric cervicothoracic specimens underwent multidirectional flexibility testing including flexion-extension, lateral bending, and axial rotation. After intact analysis, specimens were destabilized from C4 to T3 and instrumented from C3 to T4. The following reconstructions were tested: (1) 3.5-mm titanium (Ti) 2-rod, (2) 3.5-mm Ti 4-rod, (3) 4.0-mm cobalt chrome (CoCr) 2-rod, (4) 4.0-mm CoCr 4-rod, and (5) Ti 3.5- to 5.5-mm tapered rod reconstructions. The operative level range of motion and rod strain of the primary and accessory rods were quantified. RESULTS: The addition of accessory rods to a traditional 2-rod construct improved the biomechanical stability of the reconstructions in all three loading modalities for Ti ( P < .05). The accessory CoCr rods improved stability in flexion-extension and axial rotation ( P < .05). The addition of accessory rods in Ti or CoCr reconstructions did not significantly reduce rod strain ( P < .05). CoCr 2 and 4 rods exhibited less strain than both Ti 2 and 4 rods. CONCLUSION: Supplemental accessory rods affixed to traditional 2-rod constructs significantly improved stability of Ti alloys and CoCr alloy materials. The 4.0-mm CoCr rods provided greater stability than 3.5-mm Ti rods in flexion-extension, lateral bending, and axial rotation. While rod strain was not significantly reduced by the addition of accessory rods, it was reduced in CoCr rod treatment groups compared with the Ti rods.

An investigational time course study of titanium plasma spray on osseointegration of PEEK and titanium implants: an in vivo ovine model.

BACKGROUND CONTEXT: Methods to improve osseointegration of orthopedic spinal implants remains a clinical challenge. Materials composed of poly-ether-ether-ketone (PEEK) and titanium are commonly used in orthopedic applications due to their inherent properties of biocompatibility. Titanium has a clinical reputation for durability and osseous affinity, and PEEK offers advantages of a modulus that approximates osseous structures and is radiolucent. The hypothesis for the current investigation was that a titanium plasma spray (TPS) coating may increase the rate and magnitude of circumferential and appositional trabecular osseointegration of PEEK and titanium implants versus uncoated controls. PURPOSE: Using an in vivo ovine model, the current investigation compared titanium plasma-sprayed PEEK and titanium dowels versus nonplasma-sprayed dowels. Using a time course study of 6 and 12 weeks postoperatively, experimental assays to quantify osseointegration included micro-computed tomography (microCT), biomechanical testing, and histomorphometry. STUDY DESIGN/SETTING: In-vivo ovine model. METHODS: Twelve skeletally mature crossbred sheep were equally randomized into postoperative periods of 6 and 12 weeks. Four types of dowel implants-PEEK, titanium plasma-sprayed PEEK (TPS PEEK), titanium, and titanium plasma-sprayed titanium (TPS titanium) were implanted into cylindrical metaphyseal defects in the distal femurs and proximal humeri (one defect per limb, n=48 sites). Sixteen nonoperative specimens (eight femurs and eight humeri) served as zero time-point controls. Half of the specimens underwent destructive biomechanical pullout testing and the remaining half quantitative microCT to quantify circumferential bone volume within 1 mm and 2 mm of the implant surface and histomorphometry to compute direct trabecular apposition. RESULTS: There were no intra- or perioperative complications. The TPS-coated implants demonstrated significantly higher peak loads at dowel pullout at 6 and 12 weeks compared with uncoated controls (p<.05). No differences were observed across dowel treatments at the zero time-point (p>.05). MicroCT results exhibited no significant differences in circumferential osseointegration between implants within 1 mm or 2 mm of the dowel surface (p>.05). Direct appositional osseointegration of trabecular bone based on histomorphometry was higher for TPS-coated groups, regardless of base material, compared with uncoated treatments at both time intervals (p<.05). CONCLUSIONS: The current in vivo study demonstrated the biological and mechanical advantages of plasma spray coatings. TPS improved histological incorporation and peak force required for implant extraction. CLINICAL SIGNIFICANCE: Plasma spray coatings may offer clinical benefit by improving biological fixation and osseointegration within the first 6 to 12 weeks postoperatively- the critical healing period for implant-based arthrodesis procedures.

Effect of Distal Tibiofibular Destabilization and Syndesmosis Compression on the Flexibility Kinematics of the Ankle Bones: An In Vitro Human Cadaveric Model.

Background: Overcompression of the distal tibiofibular syndesmosis during open reduction and internal fixation of ankle fracture may affect multidirectional flexibility of the ankle bones. Methods: Ten cadaveric lower limbs (78.3±13.0 years, 4 female, 6 male) underwent biomechanical testing in sagittal, coronal, and axial rotation with degrees of motion quantified. The intact force (100%) was the force needed to compress the syndesmosis just beyond the intact position, and overcompression was defined as 150% of the intact force. After intact testing, the anterior inferior tibiofibular ligament (AITFL), interosseus membrane (IOM), and posterior inferior tibiofibular ligament (PITFL) were sectioned and testing was repeated. The IOM and AITFL were reconstructed in sequence and tested at 100% and 150% compression. Results: Overcompression of the syndesmosis did not significantly reduce ROM of the ankle bones for any loading modality (P > .05). IOM+AITFL reconstruction restored distal tibiofibular axial rotation to the intact condition. Axial rotation motion was significantly lower with AITFL fixation compared with IOM fixation alone (P < .05). The proximal tibiofibular syndesmosis demonstrated significantly higher motion in axial rotation with all distal reconstruction conditions. Conclusion: As assessed by direct visualization, overcompression of the distal tibiofibular syndesmosis did not reduce ROM of the ankle bones. Distal tibiofibular axial rotation was significantly lower with IOM+AITFL fixation compared with IOM augmentation alone. Distal tibiofibular axial rotation did not differ significantly from the intact condition after combined IOM+AITFL fixation. Dynamic fixation of the distal tibiofibular syndesmosis resulted in increased axial rotation at the proximal tibiofibular syndesmosis. Clinical Relevance: These biomechanical data suggest that inadvertent overcompression of the distal tibiofibular syndesmosis when fixing ankle fractures does not restrict subsequent ankle bone ROM. The AITFL is an important stabilizer of the distal tibiofibular syndesmosis in external rotation. Level of Evidence: controlled laboratory study.

3D-Printed Model in Preoperative Planning of Sciatic Nerve Decompression Because of Heterotopic Ossification: A Case Report.

CASE: A 31-year-old patient presented with an encapsulated sciatic nerve secondary to extensive hip heterotopic ossification (HO), which prevented visualization of a safe osteotomy site to avoid nerve damage. The 3D-printed model demonstrated an easily identifiable osseous reference point along the inferior aspect of the heterotopic mass, allowing for a vertical osteotomy to be safely performed. CONCLUSION: HO is associated with loss of normal anatomic topography. The current case report illustrates the use of a 3D-printed model to identify pertinent anatomic landmarks required for safe decompression of an encapsulated sciatic nerve within the anatomic region of the hip.

The contribution of E3D imaging integrated with robotic navigation: analysis of the first 80 consecutive posterior spinal fusion cases.

Eighty consecutive complex spinal robotic cases utilizing intraoperative 3D CT imaging (E3D, Group 2) were compared to 80 age-matched controls using the Excelsius robot alone with C-arm Fluoroscopic registration (Robot Only, Group 1). The demographics between the two groups were similar-severity of deformity, ASA Score for general anesthesia, patient age, gender, number of spinal levels instrumented, number of patients with prior spinal surgery, and amount of neurologic compression. The intraoperative CT scanning added several objective factors improving patient safety. There were significantly fewer complications in the E3D group with only 3 of 80 (4%) patients requiring a return to the operating room compared to 11 of 80 (14%) patients in the Robot Only Group requiring repeat surgery for implant related problems (Chi squared analysis = 5.00, p = 0.025). There was a significant reduction the amount of fluoroscopy time in the E3D Group (36 s, range 4-102 s) compared to Robot only group (51 s, range 15-160 s) (p = 0.0001). There was also shorter mean operative time in the E3D group (257 ± 59.5 min) compared to the robot only group (306 ± 73.8 min) due to much faster registration time (45 s). A longer registration time was required in the Robot only group to register each vertebral level with AP and Lateral fluoroscopy shots. The estimated blood loss was also significantly lower in Group 2 (mean 345 ± 225 ml) vs Group 1 (474 ± 397 ml) (p = 0.012). The mean hospital length of stay was also significantly shorter for Group 2 (3.77 ± 1.86 days) compared to Group 1 (5.16 ± 3.40) (p = 0.022). There was no significant difference in the number of interbody implants nor corrective osteotomies in both groups-Robot only 52 cases vs. 42 cases in E3D group.Level of evidence: IV, Retrospective review.

Validation of Impaction Grafting for Single-Level Transforaminal Lumbar Interbody Fusion-Technical Pearls and MicroCT Analysis.

STUDY DESIGN: Cadaveric study. BACKGROUND CONTEXT: Transforaminal lumbar interbody fusion (TLIF) represents a well-documented operative surgical technique utilized in the management of lumbar pathology requiring interbody arthrodesis. The microstructural properties of impaction grafting (IG) after TLIF has yet to be reported. PURPOSE: The current study was designed first, to quantify the degree, to which IG augmentation would increase intrabody final bone volume and bone graft surface contact area with the endplates; secondly to quantify the volumes of locally harvested bone and bone needed for maximal impaction. MATERIALS AND METHODS: Three cadaveric lumbosacral spine specimens were dissected into L1-L2, L3-L4, and L5-S1 motion segments for a total of 9 functional spinal units. Each interbody unit underwent a TLIF procedure with the implantation of an interbody spacer containing autogenous morselized bone. Microcomputed tomography scans were then performed to evaluate the final bone volume and bone surface contact area (BSCA). Subsequently, IG augmented TLIF procedure was carried and microcomputed tomography scans were repeated. RESULTS: IG augmentation of TLIF exhibited a 346% increase in final bone volume (TLIF: 0.30 ± 0.07 cm 3 ; IG-TLIF: 1.34 ± 0.42 cm 3 ; P < 0.05) and a 152% increase in BSCA (TLIF: 45.06 ± 15.47%; IG-TLIF: 68.28 ± 6.85%; P < 0.05) when compared with the nonimpacted TLIF treatment. In addition, the average amount of autogenous bone collected was 8.21±2.08 cm 3 , which sufficiently fulfilled the requirements for bone grafting (TLIF: 1.23 ± 0.40 cm 3 ; IG-TLIF 6.42 ± 1.20 cm 3 ). CONCLUSIONS: IG augmentation of TLIF significantly improved final bone volume in the disc space and BSCA with vertebral endplates in vitro. CLINICAL SIGNIFICANCE: Greater BSCA and final volume of bone graft reflect promisingly on their potential to increase fusion rates. Clinical studies will be needed to corroborate these findings.

Comparative Analysis of Optoelectronic Accuracy in the Laboratory Setting Versus Clinical Operative Environment: A Systematic Review.

STUDY DESIGN: Systematic review. OBJECTIVES: The optoelectronic camera source and data interpolation process serve as the foundation for navigational integrity in robotic-assisted surgical platforms. The current systematic review serves to provide a basis for the numerical disparity observed when comparing the intrinsic accuracy of optoelectronic cameras versus accuracy in the laboratory setting and clinical operative environments. METHODS: Review of the PubMed and Cochrane Library research databases was performed. The exhaustive literature compilation obtained was then vetted to reduce redundancies and categorized into topics of intrinsic accuracy, registration accuracy, musculoskeletal kinematic platforms, and clinical operative platforms. RESULTS: A total of 465 references were vetted and 137 comprise the basis for the current analysis. Regardless of application, the common denominators affecting overall optoelectronic accuracy are intrinsic accuracy, registration accuracy, and application accuracy. Intrinsic accuracy equaled or was less than 0.1 mm translation and 0.1 degrees rotation per fiducial. Controlled laboratory platforms reported 0.1 to 0.5 mm translation and 0.1 to 1.0 degrees rotation per array. Accuracy in robotic-assisted spinal surgery reported 1.5 to 6.0 mm translation and 1.5 to 5.0 degrees rotation when comparing planned to final implant position. CONCLUSIONS: Navigational integrity and maintenance of fidelity of optoelectronic data is the cornerstone of robotic-assisted spinal surgery. Transitioning from controlled laboratory to clinical operative environments requires an increased number of steps in the optoelectronic kinematic chain and error potential. Diligence in planning, fiducial positioning, system registration and intra-operative workflow have the potential to improve accuracy and decrease disparity between planned and final implant position.

Single Position Lateral Lumbar Interbody Fusion With Posterior Instrumentation Utilizing Computer Navigation and Robotic Assistance: Retrospective case review and surgical technique considerations.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To determine safety and short-term outcomes of single-position lateral lumbar interbody fusion (LLIF) with bilateral posterior instrumentation and robotic assistance. The article also describes surgical technique considerations for the procedure. METHODS: 20 patients underwent single-position LLIF with posterior instrumentation and robotic assistance. The patients were followed for a minimum of 3 months post-operatively. RESULTS: Average operative time was 211 ± 34 minutes, average blood loss was 51.25 ± 17 cc's, and average length of stay was 1.4 ± .75 days. There were no intraoperative complications, readmissions, revision surgeries, and no incidence of hardware malposition. Significant improvement in pain and ODI scores was noted at 3 month follow up. CONCLUSIONS: The study demonstrated safety and short-term clinical efficacy of minimally invasive single-position lateral lumbar interbody fusion with bilateral posterior instrumentation utilizing robotic assistance and navigation. There are certain surgical technique considerations that must be followed to ensure optimal surgical workflow and predictable outcomes.

Computer Simulated Enhancement and Planning, Robotics and Navigation With Patient Specific Implants and 3-D Printed Cages.

STUDY DESIGN: This is a retrospective cohort study. OBJECTIVES: Pre and postop Measurement Testing. This is a retrospective study of 33 consecutive interbody spacers in 21 patients who underwent pre, intra, and postoperative measurement of the middle column to determine if this would lead to more precise restoration of middle column height and spacer fit. Scaled transparencies of the pre-operative simulation of angular correction and spacer geometry could be overlayed on the post-operative imaging studies. METHODS: Multiple Observers Measurement Testing. 33 consecutive vertebral levels requiring interbody spacers for multilevel deformities had middle column height pre and post operatively measured by 3 blinded observers. The preoperative and postoperative measurements were compared using a linear regression analysis and Pearson product-moment correlation. RESULTS: Pre and postop Measurement Testing: Thirty-three interbody devices in 21 patients had pre-operative planning, simulation of cage dimensions to determine the proper cage fit which would provide for the desired correction of foraminal height and sagittal balance parameters. The simulated preoperative plan overlayed the final post-operative radiograph and was a near-perfect match in 20 of 21 patients (95.2%). Multiple Observers Measurement Testing: A Pearson product-moment correlation was run between each individual's pre-op and post-op middle column measurements. There was a strong, positive correlation between pre-operative and post-operative measurements, which was statistically significant (r = 0.903, n = 33, P < 0.001). CONCLUSIONS: This consecutive series of 33 cases demonstrated the utility of measuring the preoperative middle column length in predicting the optimal height of the spacers, intervertebral disks, and posterior vertebral body height simultaneously restoring sagittal and coronal plane alignment.

Dimensional Changes of the Neuroforamen After Anterior Decompression of the Cervical Spine: An In Vitro Micro-Computed Tomography Investigation.

OBJECTIVE: The purpose of this preliminary cadaveric study was to quantify the dimensional changes of the neuroforamen and area available for the cord (AAC) after implantation of various interbody devices with and without posterior longitudinal ligament (PLL) removal. METHODS: Eight cervical spines (C3-T1) underwent micro-computed tomography (micro-CT) scanning of the intact spine, followed by discectomy and reconstruction at 3 contiguous levels (C4-C7). Under conditions of intact and resected PLL, the following interbody device configurations were evaluated: 1) parallel, 2) lordotic, and 3) optimal lordotic. Neuroforaminal measurements were calculated from an oblique angle and the AAC was calculated by quantifying the empty space compared with the total space available for the cord. Posterior disc height and operative range lordosis were measured and compared between groups. RESULTS: Neuroforaminal height and area significantly increased for all reconstruction groups compared with intact. The increase in neuroforaminal height and area was greatest after PLL resection and placement of parallel (27.1% and 43.6%, respectively) and optimal lordotic (30.5% and 41.5%, respectively) implants. The AAC increased as a function of implant placement compared with intact and increased further after resection of the PLL (P < 0.05). There were no significant differences in operative range lordosis between parallel and lordotic implants. CONCLUSIONS: Similar to the lumbar spine, segmental distraction via placement of an interbody device produces indirect decompression of the cervical neuroforamen. Results indicate that a 34% increase in neuroforaminal area and a 51% increase in AAC are achievable with appropriately sized interbody devices and adequate distraction at the posterior aspect of the vertebral body.

Accuracy of Robotic-Assisted Spinal Surgery-Comparison to TJR Robotics, da Vinci Robotics, and Optoelectronic Laboratory Robotics.

BACKGROUND: The optoelectronic camera source and data interpolation serve as the foundation for navigational integrity in the robotic-assisted surgical platform. The objective of the current systematic review serves to provide a basis for the numerical disparity that exists when comparing the intrinsic accuracy of optoelectronic cameras: accuracy observed in the laboratory setting versus accuracy in the clinical operative environment. It is postulated that there exists a greater number of connections in the optoelectronic kinematic chain when analyzing the clinical operative environment to the laboratory setting. This increase in data interpolation, coupled with intraoperative workflow challenges, reduces the degree of accuracy based on surgical application and to that observed in controlled musculoskeletal kinematic laboratory investigations. METHODS: Review of the PubMed and Cochrane Library research databases was performed. The exhaustive literature compilation obtained was then vetted to reduce redundancies and categorized into topics of intrinsic optoelectronic accuracy, registration accuracy, musculoskeletal kinematic platforms, and clinical operative platforms. RESULTS: A total of 147 references make up the basis for the current analysis. Regardless of application, the common denominators affecting overall optoelectronic accuracy are intrinsic accuracy, registration accuracy, and application accuracy. Intrinsic accuracy of optoelectronic tracking equaled or was less than 0.1 mm of translation and 0.1° of rotation per fiducial. Controlled laboratory platforms reported 0.1 to 0.5 mm of translation and 0.1°-1.0° of rotation per array. There is a huge falloff in clinical applications: accuracy in robotic-assisted spinal surgery reported 1.5 to 6.0 mm of translation and 1.5° to 5.0° of rotation when comparing planned to final implant position. Total Joint Robotics and da Vinci urologic robotics computed accuracy, as predicted, lies between these two extremes-1.02 mm for da Vinci and 2 mm for MAKO. CONCLUSIONS: Navigational integrity and maintenance of fidelity of optoelectronic data is the cornerstone of robotic-assisted spinal surgery. Transitioning from controlled laboratory to clinical operative environments requires an increased number of steps in the optoelectronic kinematic chain and error potential. Diligence in planning, fiducial positioning, system registration, and intraoperative workflow have the potential to improve accuracy and decrease disparity between planned and final implant position. The key determining factors limiting navigation resolution accuracy are highlighted by this Cochrane research analysis.

Comparison of 3D-printed titanium-alloy, standard titanium-alloy, and PEEK interbody spacers in an ovine model.

BACKGROUND CONTEXT: Osseointegration is a pivotal process in achieving a rigid fusion and ultimately a successful clinical outcome following interbody fusion surgery. Advancements in 3D printing technology permit commonly used titanium interbody spacers to be designed with unique architectures, such as a highly interconnected and specific porous structure that mimics the architecture of trabecular bone. Interbody implants with a microscale surface roughness and biomimetic porosity may improve bony ongrowth and ingrowth compared to traditional materials. PURPOSE: The purpose of this study was to compare the osseointegration of lumbar interbody fusion devices composed of surgical-grade polyetheretherketone (PEEK), titanium-alloy (TAV), and 3D-printed porous, biomimetic TAV (3DP) using an in vivo ovine model. STUDY DESIGN: In Vivo Preclinical Animal Study METHODS: Eighteen sheep underwent two-level lateral lumbar interbody fusion randomized with either 3DP, PEEK, or TAV interbody spacers (n=6 levels for each spacer per time point). Postoperative time points were 6 and 12 weeks. Microcomputed tomography and histomorphometry were used to quantify bone volume (BV) within the spacers (ingrowth) and the surface bone apposition ratio (BAR) (ongrowth), respectively. RESULTS: The 3DP-treatment group demonstrated significantly higher BV than the PEEK and TAV groups at 6 weeks (77.3±44.1 mm3, 116.9±43.0 mm3, and 108.7±15.2 mm3, respectively) (p<.05). At 12 weeks, there were no BV differences between groups (p>.05). BV increased in all groups from the 6- to 12-week time points (p<.05). At both time points, the 3DP-treated group (6w: 23.6±10.9%; 12w: 36.5±10.9%) had significantly greater BAR than the PEEK (6w: 8.6±2.1%; 12w: 14.0±5.0%) and TAV (6w: 6.0±5.7%; 12w: 4.1±3.3%) groups (p<.05). CONCLUSIONS: 3DP interbody spacers facilitated greater total bony ingrowth at 6 weeks, and greater bony ongrowth postoperatively at both 6 and 12 weeks, in comparison to solid PEEK and TAV implants. CLINICAL SIGNIFICANCE: Based on these findings, the 3DP spacers may be a reasonable alternative to traditional PEEK and TAV spacers in various clinical applications of interbody fusion.

Lower incidence of dysphagia with cervical arthroplasty compared with ACDF in a prospective randomized clinical trial.

STUDY DESIGN: The current study of 251 consecutive 1-level anterior cervical reconstructions was undertaken to compare the incidence of dysphagia between cervical disk replacement and conventional anterior cervical fusion and instrumentation. OBJECTIVES: This is a report of 251 patients from 5 investigational centers in the Food and drug Administration's prospective, randomized porous-coated motion (PCM) trial using a validated dysphagia outcomes instrument. The dysphagia data for both PCM and anterior cervical diskectomy and fusion (ACDF) patients were reviewed from 5 centers to (1) compare the severity of dysphagia, (2) compare the postoperative incidence of dysphagia, and (3) to compare the resolution of perioperative dysphagia. SUMMARY OF BACKGROUND DATA: Dysphagia and dysphonia after anterior surgical approaches to the cervical spine have been previously reported. The current prospective, randomized investigation quantifies clinical dysphagia based on 3 criteria-severity, incidence, and resolution-in a time-course evaluation. METHODS: Patients between 18 and 65 years with 1-level symptomatic cervical radiculopathy and/or myelopathy for progressive neurologic symptoms, were randomized to undergo anterior decompression and PCM arthroplasty (N=151) or ACDF (control) (N=100). Patients self-reported dysphagia severity using the Bazaz scale preoperatively and at follow-up. The Bazaz scale has 4 classes of severity based upon the problems with swallowing that the patient has with both liquids and solids. RESULTS: The Bazaz results demonstrate that although both the PCM and ACDF groups exhibited an initial postoperative problem with swallowing, the PCM group continued to improve with increasing time after implantation, whereas the ACDF only improved minimally. The PCM treatments indicated significantly lower incidence of dysphagia at 3 and 12 months postoperatively compared with ACDF controls (P<0.05). An increase in dysphagia severity at either the 6-week or 3-month follow-up visit was reported in 35 (42%) PCM and 29 (64%) ACDF subjects. Long-term resolution of these symptoms was noted in 74% (26/35) of the PCM subjects as compared with 41.4% (12/29) of the ACDF subjects (P=0.015). CONCLUSIONS: In a prospective randomized clinical study the incidence of postoperative dysphagia and the long-term resolution of the dysphagia was greatly improved in the PCM group compared with the instrumented ACDF control group.

Biomechanical analysis of occipitocervical stabilization techniques: emphasis on integrity of osseous structures at the occipital implantation sites.

OBJECTIVE: The objective of the current study was to quantify and compare the multidirectional flexibility properties of occipital anchor fixation with conventional methods of occipitocervical screw fixation using nondestructive and destructive investigative methods. METHODS: Fourteen cadaveric occipitocervical specimens (Oc-T2) were randomized to reconstruction with occipital anchors or an occipital plate and screws. Using a 6-degree-of-freedom spine simulator with moments of ± 2.0 Nm, initial multidirectional flexibility analysis of the intact and reconstructed conditions was performed followed by fatigue loading of 25,000 cycles of flexion-extension (x-axis, ± 2.0 Nm), 15,000 cycles of lateral bending (z-axis, ± 2.0 Nm), and 10,000 cycles of axial rotation (y-axis, ± 2.0 Nm). Fluoroscopic images of the implantation sites were obtained before and after fatigue testing and placed on an x-y coordinate system to quantify positional stability of the anchors and screws used for reconstruction and effect, if any, of the fatigue component. Destructive testing included an anterior flexural load to construct failure. Quantification of implant, occipitocervical, and atlantoaxial junction range of motion is reported as absolute values, and peak flexural failure moment in Newton-meters (Nm). RESULTS: Absolute value comparisons between the intact condition and 2 reconstruction groups demonstrated significant reductions in segmental flexion-extension, lateral bending, and axial rotation motion at the Oc-C1 and C1-2 junctions (p < 0.05). The average bone mineral density at the midline keel (1.422 g/cm3) was significantly higher compared with the lateral occipital region at 0.671 g/cm3 (p < 0.05). There were no significant differences between the occipital anchor and plate treatments in terms of angular rotation (degrees; p = 0.150) or x-axis displacement (mm; p = 0.572), but there was a statistically significant difference in y-axis displacement (p = 0.031) based on quantitative analysis of the pre- and postfatigue fluoroscopic images (p > 0.05). Under destructive anterior flexural loading, the occipital anchor group failed at 90 ± 31 Nm, and the occipital plate group failed at 79 ± 25 Nm (p > 0.05). CONCLUSIONS: Both reconstructions reduced flexion-extension, lateral bending, and axial rotation at the occipitocervical and atlantoaxial junctions, as expected. Flexural load to failure did not differ significantly between the 2 treatment groups despite occipital anchors using a compression-fit mechanism to provide fixation in less dense bone. These data suggest that an occipital anchor technique serves as a biomechanically viable clinical alternative to occipital plate fixation.

Regeneration of a spinal ligament after total lumbar disk arthroplasty in primates.

Total disk arthroplasty (TDA) is a new procedure that replaces the intervertebral disk space with an artificial motion segment and necessitates the resection of the anterior longitudinal ligament (ALL). We assessed whether a collagen-based graft made from porcine small-intestine submucosa (SIS) can be used as a regenerative scaffold to restore the function and structure of the ALL in the lumbar spine. A total of 10 mature male baboons underwent TDA at L5-L6 using one of two treatments: (1) TDA only (n = 5) or (2) TDA combined with SIS (n = 5). Six months postoperatively, mock revision surgery was performed to assess tissue adhesions followed by non-destructive multidirectional flexibility testing of the spinal segment. The vertebral segments were then processed for histology. The tissue adhesion score was 2.8 +/- 0.8 in the TDA only group and 1.8 +/- 1.4 in the TDA-SIS group (p = 0.2). Segmental range of motion and the length of the neutral zone were similar in both groups. Histology showed that the SIS scaffold led to an organized ligamentous structure with a significantly (p = 0.027) higher thickness (2.18 +/- 0.25 mm) compared to the connective tissue structure in the TDA-only group (1.66 +/- 0.33 mm). We concluded that using a SIS bioscaffold after TDA did not lead to increased great vessel adhesion while its use facilitated the formation of highly organized ligamentous tissues. However, the SIS- induced and newly formed ligamentous tissue anterior to the spinal segment did not lead to a measurable limitation of spinal extension.

Ceramic granules enhanced with B2A peptide for lumbar interbody spine fusion: an experimental study using an instrumented model in sheep.

OBJECT: New generations of devices for spinal interbody fusion are expected to arise from the combined use of bioactive peptides and porous implants. The purpose of this dose-ranging study was to evaluate the fusion characteristics of porous ceramic granules (CGs) coated with the bioactive peptide B2A2-K-NS (B2A) by using a model of instrumented lumbar interbody spinal fusion in sheep. METHODS: Instrumented spinal arthrodesis was performed in 40 operative sites in 20 adult sheep. In each animal, posterior instrumentation (pedicle screw and rod) and a polyetheretherketone cage were placed in 2 single-level procedures (L2-3 and L4-5). All cages were packed with graft material prior to implantation. The graft materials were prepared by mixing (1:1 vol/vol) CGs with or without a B2A coating and morselized autograft. Ceramic granules were coated with B2A at 50, 100, 300, and 600 microg/ml granules (50-B2A/CG, 100-B2A/CG, 300-B2A/CG, and 600-B2A/CG, respectively), resulting in 4 B2A-coated groups plus a control group (uncoated CGs). Graft material from each of these groups was implanted in 8 operative sites. Four months after arthrodesis, interbody fusion status was assessed with CT, and the interbody site was further evaluated with quantitative histomorphometry. RESULTS: All B2A/CG groups had higher CT-confirmed interbody fusion rates compared with those in controls (CGs only). Seven of 8 sites were fused in the 50-B2A/CG, 100-B2A/CG, and 300-B2A/CG groups, whereas 5 of 8 sites were fused in the group that had received uncoated CGs. New woven and lamellar bone spanned the fusion sites with excellent osseointegration. There was no heterotopic ossification or other untoward events attributed to the use of B2A/CG in any group. Each B2A/CG treatment produced more new bone than that in the CG group. CONCLUSIONS: Bioactive treatment with B2A effectively enhanced the fusion capacity of porous CGs. These findings suggest that B2A/CG may well represent a new generation of biomaterials for lumbar interbody fusion and indicate that additional studies are warranted.

An investigational study of a dual-layer, chorion-free amnion patch as a protective barrier following lumbar laminectomy in a sheep model.

The inherent properties of the human amniotic membrane (HAM) suggest its potential for use as a physical barrier during surgery to protect neural elements and vessels from the surrounding environment. The objective of this study was to evaluate the effect of a dual-layer, chorion-free amnion patch (DLAM; ViaShield®, Globus Medical Inc., Audubon, PA, USA) processed from HAM as a protective barrier following lumbar laminectomy in a sheep model. A multiplex immunoassay was performed to quantify the inherent cytokines present in the amnion after processing. Twelve skeletally mature female crossbred Suffolk sheep were randomly divided into two equal post-operative periods (4 and 10 weeks). Each sheep underwent a laminectomy at L3 and L5, and one of the surgical sites randomly received the DLAM treatment. At each postsurgical time point, the extent of epidural fibrosis and neurohistopathological responses at the laminectomy sites was assessed based on epidural fibrosis-dura tenacity scores and decalcified histology, respectively. Immunoassay results showed that inflammatory mediators and immunomodulatory cytokines were present in the amnion after processing, but no proangiogenic cytokines were detected. At 10 weeks, tissue tenacity was significantly less in the DLAM treatment group when compared with the operative control (1.2 ± 0.4 vs. 2.8 ± 0.4, p < 0.05), demonstrating the ability of DLAM to act as a barrier and cover the dura. Gross observations showed fewer fibroblasts in the DLAM group in comparison with the control at both post-operative time points. Fibroblast infiltration analysis indicated that at both 4 and 10 weeks, there were significantly more infiltrated fibroblasts in the operative control sites than in the DLAM-treated sites, expressed as a percentage of the total number of fibroblasts present (4 weeks: 72.3 ± 10.2% vs. 10.8 ± 10.1%, p < .05; 10 weeks: 84.9 ± 15.8% vs. 43.1 ± 11.6%, p < .05). Additionally, fibroblasts travelled further into the dura in the operative control group compared with the DLAM-treated group at both time points. In conclusion, this study found that DLAM reduced fibroblast infiltration and tissue tenacity following lumbar laminectomy in a sheep animal model. These findings support the potential use of DLAM in clinical practice as a protective barrier for neural elements and anterior vessels.

A comprehensive biomechanical analysis of sacral alar iliac fixation: an in vitro human cadaveric model.

In BriefIn this in vitro investigation, we compared the multidirectional flexibility properties of sacral alar iliac fixation with conventional methods of sacral and sacroiliac fixation using nondestructive and destructive investigative methods. The study demonstrated that S1-2 sacral fixation alone significantly increases sacroiliac motion under all loading modalities, while sacral alar iliac fixation reduced motion in axial rotation at the sacroiliac joint and offers potential advantages of a lower instrumentation profile and ease of assembly compared to conventional sacroiliac screw instrumentation.