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.

100 Complex posterior spinal fusion cases performed with robotic instrumentation.

Robotic navigation has been shown to increase precision, accuracy, and safety during spinal reconstructive procedures. There is a paucity of literature describing the best techniques for robotic-assisted spine surgery for complex, multilevel cases or in cases of significant deformity correction. We present a case series of 100 consecutive multilevel posterior spinal fusion procedures performed for multilevel spinal disease and/or deformity correction. 100 consecutive posterior spinal fusions were performed for multilevel disease and/or deformity correction utilizing robotic-assisted placement of pedicle screws. The primary outcome was surgery-related failure, which was defined as hardware breakage or reoperation with removal of hardware. A total of 100 consecutive patients met inclusion criteria. Among cases included, 31 were revision surgeries with existing hardware in place. The mean number of levels fused was 5.6, the mean operative time was 303 min, and the mean estimated blood loss was 469 mL. 28 cases included robotic-assisted placement of S2 alar-iliac (S2AI) screws. In total, 1043 pedicle screws and 53 S2AI screws were placed with robotic-assistance. The failure rate using survivorship analysis was 18/1043 (1.7%) and the failure rate of S2AI screws using survivorship analysis was 3/53 (5.7%). Four patients developed postoperative wound infections requiring irrigation and debridement procedures. None of the 1043 pedicle screws nor the 53 S2AI screws required reoperation due to malpositioning or suboptimal placement. This case series of 100 multilevel posterior spinal fusion procedures demonstrates promising results with low failure rates. With 1043 pedicle screws and 53 S2AI screws, we report low failure rates of 1.7% and 5.7%, respectively with zero cases of screw malpositioning. Robotic screw placement allows for accurate screw placement with no increased rate of postoperative infection compared to historical controls. Level of evidence: IV, Retrospective review.

Robot for Ligament Tensioning and Assessment of Spinal Stability.

STUDY DESIGN: An in vitro human cadaveric biomechanics study. OBJECTIVE: A proof-of-concept study to quantify whether or not differences in segmental mobility associated with spinal instability could be detected by a robotic distraction system. METHODS: Testing was performed in fresh human cadaveric tissue. A prototype Robotic Middle Column Distractor was attached unilaterally to the pedicles of L3-4. Distraction forces up to 150 N were applied first in the intact state, and following discectomy of L3-4. Motions were recorded by time-indexed visual and fluoroscopic images, and analyzed to measure actual motions achieved. Functions of the robot unit were monitored during the procedure and evaluated qualitatively. RESULTS: A difference of 2.5 mm in z-axis motion was detected at 150 N load between the intact and post-discectomy states. The robot coupled with the image analysis method was able to clearly detect the difference between the intact ("stable") and post-discectomy ("unstable") spine. Data analysis of fluoroscopic images taken during the procedure showed greater motion than perceived by the investigators from qualitative review of visual data. All monitored robot functions performed within design parameters without error. CONCLUSION: The study demonstrates the feasibility and utility of utilizing an intraoperative robotic distractor to measure the amount of spinal mobility present at a level. This could lead to an important clinical tool for both diagnostic functions as well as operative assist functions.

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.

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.

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.

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.

Effects of a cervical disc prosthesis on maintaining sagittal alignment of the functional spinal unit and overall sagittal balance of the cervical spine.

The object of this study is to review the early clinical results and radiographic outcomes following insertion of the Bryan Cervical Disc Prosthesis (Medtronic Sofamor Danek, Memphis, TN), together with its effect on maintaining sagittal alignment of the functional spinal unit (FSU) and overall sagittal balance of the cervical spine for the treatment of single-level or two-level symptomatic disc disease. Forty-seven patients with symptomatic single or two-level cervical disc disease who received the Bryan Cervical Artificial Disc were reviewed prospectively. A total of 55 Bryan disc were placed in 47 patients. A single-level procedure was performed in 39 patients and a two-level procedure in the other eight. Radiographic and clinical assessments were made preoperatively and at 1.5, 3, 6, 9, 12, and 18 and up to 33 months postoperatively. Mean follow-up duration was 24 months, ranging from 13 to 33 months. Periods were categorized as early follow up (1.5-3 months) and late follow up (6-33 months). The visual analogue scale (VAS), neck disability index(NDI), Odom's criteria were used to assess pain and clinical outcomes. Static and dynamic radiographs were measured by hand and computer to determine the range of motion (ROM), the angle of the functional segmental unit (FSU), and the overall cervical alignment (C2-7 Cobb angle). With all of these data, we evaluated the change of the preoperative lordosis (or kyphosis) of the FSU and Overall sagittal balance of the cervical spine during the follow-up period. There was a statistically significant improvement in the VAS score from 7.0 +/- 2.6 to 2.0 +/- 1.5 (paired-t test, P = 0.000), and in the NDI from 21.5 +/- 5.5 to 4.5 +/- 3.9 (paired-t test P = 0.000). All of the patients were satisfied with the surgical results by Odom's criteria. The postoperative ROM of the implanted level was preserved without significant difference from preoperative ROM of the operated level. Only 36% of patients with a preoperative lordotic sagittal orientation of the FSU were able to maintain lordosis following surgery. However, the overall sagittal alignment of the cervical spine was preserved in 86% of cases at the final follow up. Interestingly, preoperatively kyphotic FSU resulted in lordotic FSU in 13% of patients during the late follow-up, and preoperatively kyphotic overall cervical alignment resulted in lordosis in 33% of the patients postoperatively. Clinical results are encouraging, with significant improvement seen in the Bryan Cervical Artificial disc. The Bryan disc preserves motion of the FSU. Although the preoperative lordosis (or kyphosis) of the FSU could not always be maintained during the follow-up period, the overall sagittal balance of the cervical spine was usually preserved.

Effect of age on clinical and radiographic outcomes and adverse events following 1-level lumbar arthroplasty after a minimum 2-year follow-up.

OBJECT: Lumbar arthroplasty is approved in the US for the treatment of degenerative disc disease at 1 level in skeletally mature patients. However, a bias toward older patients (> 45 years of age) who are otherwise indicated for the procedure may exist. In this study, the clinical outcomes of patients from the Charité Investigational Device Exemption (IDE) study were analyzed on the basis of patient age. METHODS: There were 276 patients enrolled in the IDE study of the Charité Artificial Disc who underwent 1-level arthroplasty at either L4-5 or L5-S1, including 71 nonrandomized and 205 randomized individuals. Patient data were analyzed based on age (18-45 years [217 patients, Group 1] compared with 46-60 years [59 patients, Group 2]). Statistical analyses were performed based on 2-year postoperative improvements in Oswestry Disability Index (ODI), 36-item Short Form Health Survey (SF-36), and visual analog scale (VAS) scores (clinical outcome), as well as range of motion (radiographic outcome), and adverse events. RESULTS: There was no significant difference between the groups with respect to level implanted, operative time, blood loss, changes in ODI and VAS scores or any of the 8 component scores of the SF-36, compared with baseline, at all time points throughout the 24-month follow-up period (p > 0.10). Patient satisfaction was equivalent at 24 months, with 87% satisfaction in Group 1 and 85% satisfaction in Group 2 (no statistical difference). In addition, no significant differences were identified with respect to adverse events including approach related, neurological, technique related, or reoperation. CONCLUSIONS: Although patients > 45 years of age may have comorbidities or contraindications for arthroplasty for a number of reasons, particularly osteopenia, this analysis demonstrates that patients who are indicated for 1-level arthroplasty experience similar clinical outcome, satisfaction, or adverse events compared with their younger counterparts.

Effect of previous surgery on clinical outcome following 1-level lumbar arthroplasty.

OBJECT: A secondary lumbar surgery at a previously surgically treated level is believed to result in minimal clinical improvement. The clinical results of the CHARITE Investigational Device Exemption (IDE) study were analyzed to assess the effect of previous surgery on clinical outcomes following either total disc replacement with the CHARITE device or anterior lumbar interbody fusion with a BAK cage and iliac crest autograft. METHODS: Patients with prior microdiscectomy, laminectomy, or minimal medial facetectomy were not excluded from enrollment in the CHARITE IDE study. Thus, the following 3 groups were analyzed: all patients treated with the CHARITE Artificial Disc, whether randomized or nonrandomized; only patients treated with CHARITE devices randomized against patients with BAK devices; and control patients with BAK devices. Each group was further subdivided based on the patients' medical history, whether they had undergone prior surgery (prior surgery group) or had not (no prior surgery group). For all groups, baseline demographics were collected and compared for any potential recruitment bias. Postoperative improvements based on Oswestry Disability Index (ODI), visual analog scale (VAS), and patient satisfaction scores were further collected and statistically analyzed. RESULTS: For all 3 groups, there were no statistical differences in clinical improvement from 3 months to 2 years postoperatively as measured using ODI and VAS scores between the subgroups (those who had prior surgery and those who did not). CONCLUSIONS: Patients indicated for 1-level lumbar arthroplasty with previous lumbar decompressive surgery can be expected to have similar clinical outcomes to patients undergoing arthroplasty without prior lumbar decompressive surgery. Similarly, candidates for anterior lumbar fusion with prior decompressive surgery may experience similar benefits from the surgical procedure as those without.

Patient selection for lumbar arthroplasty and arthrodesis: the effect of revision surgery in a controlled, multicenter, randomized study.

OBJECT: Patient selection is perhaps the most important factor in successful lumbar surgery. In this study, the authors analyzed the clinical outcomes of patients enrolled in the CHARITE investigational device exemption (IDE) trial who underwent revision surgery after primary total disc replacement with CHARITE or an anterior lumbar interbody fusion (ALIF) with placement of a BAK cage and iliac crest autograft. This revision surgery was either a supplemental posterior lumbar fixation or a 360 degrees fusion. Statistical analysis was conducted to compare clinical success in patients who underwent revision surgery with those who did not. METHODS: The patients enrolled in the CHARITE IDE study were divided into 6 groups according to treatment and repeated operation status, and their Oswestry Disability Index (ODI) and visual analog scale (VAS) scores at the 2-year follow-up and at baseline were compared. The patients had received the following treatments by group: A) ALIF without reoperation; B) ALIF with conversion to 360 degrees fusion; C) arthroplasty (randomized) without repeated operation; D) arthroplasty with supplemental posterior lumbar fixation; E) arthroplasty (nonrandomized) without repeated operation; and F) arthroplasty (nonrandomized) with supplemental posterior lumbar fixation. Outcome scores in the groups of patients who required revision surgeries (Groups B, D, and F; 23 patients) were compared with the groups that did not require revision surgery (Groups A, C, and E; 299 patients). RESULTS: Patients who required revision surgery had a significantly lower level of clinical improvement than those who did not. The mean change in ODI score was -53.0% in Groups A, C, and E, but just -12.7% in Groups B, D, and F (p < 0.0001). The mean change in VAS score was -59.1% in Groups A, C, and E, compared to -23.4% in Groups B, D, and F (p < 0.0001). No significant differences were identified in analyzing absolute change in scores and the percentage change. A comparison of outcomes in patients who had undergone arthroplasty without reoperation (Groups C and E) with all patients who had undergone revision surgery (Groups B, D, and F) demonstrated similar results (p < 0.0001). CONCLUSIONS: The 7.1% of patients who underwent a secondary stabilization procedure had poor clinical improvement. This finding may indicate that if the alternative treatment had been the initial treatment, these patients would not have benefited, and further implies a 7.1% rate of imprecision in preoperative evaluation.

Distribution of in vivo and in vitro range of motion following 1-level arthroplasty with the CHARITE artificial disc compared with fusion.

OBJECT: One of the goals of lumbar arthroplasty is to restore and maintain range of motion (ROM) and to protect adjacent levels from abnormal motion, which may be a factor in transition syndrome following arthrodesis. In this study, in vitro ROM results were compared with in vivo, 2-year postoperative radiographic ROM evaluations. METHODS: Radiographs of patients enrolled in the CHARITE investigational device exemption study were analyzed at baseline and at 2 years postoperatively. The ROM in flexion/extension at the implanted and adjacent levels was measured, normalized, and compared with ROM results obtained using cadaver (in vitro) evaluations. RESULTS: Preoperative ROM distributions in patients enrolled for arthroplasty or fusion at the L4-5 level was as follows: 28% motion was observed at L3-4, 35% at L4-5 and 37% at L5-S1. Following a one-level arthroplasty at L4-5, the in vivo ROM distribution from L-3 to S-1 at the 2-year time point was 36% at L3-4, 30% at L4-5 and 35% at L5-S1. Following a one-level fusion with BAK and pedicle screws at L4-5, the in vivo ROM distribution from L-3 to S-1 at the 2-year time point was 45% at L3-4, 9% at L4-5 and 46% at L5-S1. CONCLUSIONS: The baseline as well as the 2-year in vivo data confirmed previously published in vitro data. One-level arthroplasty was shown herein to replicate the normal distribution of motion of the intact spine.

Middle-Column Gap Balancing and Middle-Column Mismatch in Spinal Reconstructive Surgery.

BACKGROUND: Middle-column gap balancing (MCGB) is a reference measurement of the path of the posterior longitudinal ligament (PLL), which is reconstructed under tension and balanced by the combined height of the posterior one-third of the vertebral bodies and the posterior one-third of the disks, including any intervening load-sharing spacers. This measurement allows for a comparison of the ligamentous component of the middle column (PLL) with the load-sharing components (posterior one-third vertebral body + disk ). This difference gives rise to a "middle-column mismatch," which provides a linear measurement of the redundancy of the ligaments and neural elements, which relates to the correct cage, spacer, or load-bearing height, which is optimized. METHODS: For phase 1 measurement testing, 24 consecutive patients underwent reliable flexion, extension, and neutral lateral radiographic studies with a calibrated marker. The anterior, middle, and posterior columns were measured using a custom software program capable of measuring the length of curved lines specifically written for this purpose. For phase 2 measurement testing, 21 consecutive patients undergoing surgery with multilevel deformities for cervical, thoracic, and lumbar procedures had MCGB height pre- and postoperatively measured by 3 blinded observers. The preoperative and postoperative measurements were compared using a linear regression analysis and Pearson product-moment correlation. RESULTS: In phase 1 measurement testing the flexion, extension, and neutral bending radiographs of spinal segments not containing deformities showed that the middle column had the most reliable measurements of spinal axial height both in the actual measurements of change from flexion to extension (mm) and in percentage of change. In phase 2 measurement testing, a Pearson product-moment correlation was run between each individual's pre- and postoperative middle-column measurements. There was a strong positive correlation between preoperative and postoperative measurements, which was statistically significant (r = 0.983, n = 21, P < .01). CONCLUSIONS: This consecutive series of 21 deformity patients demonstrated the utility of measuring the preoperative middle-column length in predicting the optimal height of the spacers and intervertebral disks, and posterior vertebral body height, simultaneously restoring sagittal and coronal plane alignment. Key points of this study include the following: (1) Spinal balance requires optimizing spinal height, which is a curved line in order to accommodate cervical lordosis, thoracic kyphosis, and lumbar lordosis. (2) Software programs can allow measurement of the preoperative curved circuitous course of the PLL and vertebral body misalignment; this curved length is predictive of the optimal postoperative middle-column height after spinal osteotomies and intervertebral spacer insertion. (3) All 3 dimensions are important to optimize in deformity correction: sagittal plane, coronal plane, and axial spinal height.

The SPOT GRADE: A New Method for Reproducibly Quantifying Surgical Wound Bleeding.

STUDY DESIGN: Benchtop model with prospective surgeon video testing. OBJECTIVE: To create a surface bleeding severity scale, the SPOT GRADE (SG), for quantitative assessment of target bleeding site (TBS) blood loss. This is of particular interest for spinal surgery due to epidural bleeding and an inability to use diathermy and radiofrequency cautery close to nerve roots. SUMMARY OF BACKGROUND DATA: A novel apparatus perfusable at known flow rates and simulating different sized wounds was used to create movies to educate surgeons on specific degrees of bleeding. METHODS: Training (36) and testing (108) videos were created using a benchtop apparatus employing different bleeding severities based on the six-level SG (none, minimal, mild, moderate, severe, and extreme) and TBS sizes (1, 10, and 50 cm). Fourteen surgeons in four specialties (cardiothoracic, abdominal, spine, and orthopedic lower extremity) were trained and tested to evaluate SG characteristics including inter-rater and intrarater reliability. RESULTS: The interclass correlation coefficient was estimated to be 0.89840 (95% confidence interval [CI]: 0.85771, 1), whereas the intraclass correlation coefficient was estimated to be 0.93673 (95% CI: 0.89603, 1). In 98% of cases (95% CI: 0.9736, 0.9927), surgeons correctly identified eligible bleeds for a future clinical trial (scores = 1, 2, or 3) and in 91% of cases (95% CI: 0.8895, 0.9344), surgeons correctly identified noneligible bleeds (scores = 4 or 5). In 98.6% of cases (95% CI: 0.9777, 0.9945), physicians correctly identified true hemostasis (score = 0). Based upon these data the probability of a physician rating a bleed incorrectly as hemostasis (score = 0) is estimated to be 1.51% (95% CI: 0.0061, 0.0363). CONCLUSION: This SG is reproducible and reliable providing a basis for educating surgeons on TBS blood loss. It appears to be a new standard for evaluating wound blood loss. LEVEL OF EVIDENCE: 2.

Prevalence of heterotopic ossification following total disc replacement. A prospective, randomized study of two hundred and seventy-six patients.

BACKGROUND: Despite reports of good clinical outcomes in patients treated with lumbar and cervical disc replacements, varying degrees of heterotopic bone have been observed around these devices. The purposes of the present study were to determine the prevalence of heterotopic ossification following lumbar disc replacement and to investigate whether heterotopic ossification results in loss of motion or negatively affects clinical outcome. METHODS: All preoperative and postoperative radiographs from a completed prospective, randomized, United States Food and Drug Administration-regulated trial comparing replacement with the CHARITE Artificial Disc with anterior interbody arthrodesis were analyzed. In each of 276 patients treated with disc replacement, heterotopic ossification was categorized with use of a validated 5-point radiographic classification system both preoperatively and at all protocol-specified follow-up intervals to two years. The range of motion on flexion and extension radiographs made preoperatively was compared with that on radiographs made two years postoperatively, and the motion was correlated with the presence or absence of heterotopic ossification. Similarly, validated clinical outcome measures were correlated with the presence or absence of heterotopic ossification at two years. RESULTS: The prevalence of heterotopic ossification in the 276 consecutive patients treated with lumbar disc replacement with the CHARITE Artificial Disc was 4.3%. There were four cases of Class-I heterotopic ossification and eight cases of Class-II heterotopic ossification. In five of the twelve patients, heterotopic bone was visible as early as six weeks postoperatively, and eleven of the twelve patients had evidence of heterotopic ossification by three months postoperatively. The postoperative range of motion exceeded the preoperative range in all of the patients with heterotopic ossification. With the numbers available, no difference in either the range of motion or the clinical outcome at twenty-four months postoperatively was found between the patients who had and those who did not have heterotopic ossification. CONCLUSIONS: Heterotopic ossification is infrequent in patients treated with the CHARITE Artificial Disc, and it does not impact the range of motion or clinical outcome.

Five-Year Follow-Up of a Prospective, Randomized Trial Comparing Two Lumbar Total Disc Replacements.

STUDY DESIGN: This was a prospective, randomized, controlled, multicenter study. OBJECTIVE: The purpose of this study was to compare outcomes of two lumbar total disc replacements (TDRs) at 5-year follow-up and report results of serum ion level analysis in a subgroup of patients receiving a metal-on-metal implant. SUMMARY OF BACKGROUND DATA: Lumbar TDR has been compared with fusion in several randomized studies, finding TDR noninferior to fusion and superior on some measures. Receiving less attention has been comparing TDR devices. Additionally, there is concern about metal-on-metal implants, with little data available for spine devices. METHODS: The study included 204 patients receiving Kineflex-L (investigational) and 190 receiving CHARITÉ (control). Outcome measure included Oswestry Disability Index, visual analog pain scales (VAS), patient satisfaction, neurological status, complications, reoperations, and a composite success score. Radiographic assessment included range of motion, subsidence, and heterotrophic ossification. In 32 investigational patients, serum ion analysis was performed for cobalt and chromium. These values were compared with Medicines and Healthcare Products Regulatory Agency values to merit monitoring total hip replacement patients for potential wear problems. RESULTS: Mean Oswestry and VAS scores in both groups improved significantly by 6 weeks and remained improved during 5-year follow-up (Oswestry Disability Index, scores in both groups were approximately 60 preoperatively vs. 20 at 2- and 5-year follow-up; P < 0.01; VAS scores improved >50% by 6 weeks and remained significantly improved; P < 0.05). Approximately 11% of both groups underwent reoperation. Radiographic analysis found segmental range of motion decreased at 3 month, then increased through 24 months, and was maintained thereafter. Serum ion level analysis found the greatest mean value at any follow-up point was less than 20% of Medicines and Healthcare Products Regulatory Agency recommended minimum value to merit monitoring hip replacement patients. CONCLUSION: This prospective, randomized study comparing two TDRs found no significant differences in outcomes during 5-year follow-up. Both provided statistically significant improvements by 6 weeks that were maintained. This results support other studies. Serum ion levels in TDR patients were well below the recommended threshold levels to merit monitoring.