Kee D. Kim

Computer-assisted thoracic pedicle screw placement: An in vitro feasibility study

Study Design In this cadaveric study, a computer-assisted image guidance system was tested for accuracy of thoracic pedicle screw placement. Objectives Evaluate the system’s accuracy for thoracic pedicle screw placement in vitro. Summary of Background Data The effective use and reliability of pedicle screw instrumentation in providing short-segment stabilization and correction of deformity is well known in the lumbar spine. Pedicle screw placement in the thoracic spine is difficult because of the small dimensions of the thoracic pedicles and risk to the adjacent spinal cord and neurovascular structures. Investigators have shown the improved accuracy of computer-assisted lumbar pedicle screw placement; but the accuracy of computer-assisted thoracic pedicle screw placement, which is becoming more widely used, has not been shown. Methods In five human cadavers, 120 thoracic pedicle screws were placed with computer-assisted image guidance. The largest clinically feasible screw was used based on the cross-sectional dimensions of each pedicle. The accuracy was assessed by postoperative computed tomography and visual inspection. Results The overall pedicle cortex violation was 23 of 120 pedicles (19.2%). Nine violations (7.5%) were graded as major and 14 (11.7%) as minor. A marked and progressive learning curve was evident with the perforation rates that decreased from 37.5% in the first cadaver to 4.2% in the last two cadavers. Conclusions Accurate thoracic pedicle screw placement is feasible with computer-assisted surgery. However, as with any other new surgical technology, the learning curve must be recognized and incorporated into the necessary fundamental knowledge and experience for these procedures.

Biomechanical Analysis and Review of Lateral Lumbar Fusion Constructs

Study Design. Biomechanical study and the review of literature on lumbar interbody fusion constructs. Objective. To demonstrate the comparative stabilizing effects of lateral interbody fusion with various supplemental internal fixation options. Summary of Background Data. Lumbar interbody fusion procedures are regularly performed using anterior, posterior, and more recently, lateral approaches. The biomechanical profile of each is determined by the extent of resection of local supportive structures, implant size and orientation, and the type of supplemental internal fixation used. Methods. Pure moment flexibility testing was performed using a custom-built 6 degree-of-freedom system to apply a moment of ±7.5 Nm in each motion plane, while motion segment kinematics were evaluated using an optoelectronic motion system. Constructs tested included the intact spine, stand-alone extreme lateral interbody implant, interbody implant with lateral plate, unilateral and bilateral pedicle screw fixation. These results were evaluated against those from literature-reported biomechanical studies of other lumbar interbody constructs. Results. All conditions demonstrated a statistically significant reduction in range of motion (ROM) as a percentage of intact. In flexion-extension, ROM was 31.6% stand-alone, 32.5% lateral fixation, and 20.4% and 13.0% unilateral and bilateral pedicle screw fixation, respectively. In lateral bending, the trend was similar with greater reduction with lateral fixation than in flexion-extension; ROM was 32.5% stand-alone, 15.9% lateral fixation, and 21.6% and 14.4% unilateral and bilateral pedicle screw fixation. ROM was greatest in axial rotation; 69.4% stand-alone, 53.4% lateral fixation, and 51.3% and 41.7% unilateral and bilateral pedicle screw fixation, respectively. Conclusion. The extreme lateral interbody construct provided the largest stand-alone reduction in ROM compared with literature-reported ALIF and TLIF constructs. Supplemental bilateral pedicle screw-based fixation provided the overall greatest reduction in ROM, similar among all interbody approach techniques. Lateral fixation and unilateral pedicle screw fixation provided intermediate reductions in ROM. Clinically, surgeons may evaluate these comparative results to choose fixation options commensurate with the stability requirements of individual patients.

Cervical total disc replacement with the mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: A prospective, randomized, controlled multicenter clinical trial: Clinical article

OBJECT Cervical total disc replacement (TDR) is intended to treat neurological symptoms and neck pain associated with degeneration of intervertebral discs in the cervical spine. Anterior cervical discectomy and fusion (ACDF) has been the standard treatment for these indications since the procedure was first developed in the 1950s. While TDR has been shown to be a safe and effective alternative to ACDF for treatment of patients with degenerative disc disease (DDD) at a single level of the cervical spine, few studies have focused on the safety and efficacy of TDR for treatment of 2 levels of the cervical spine. The primary objective of this study was to rigorously compare the Mobi-C cervical artificial disc to ACDF for treatment of cervical DDD at 2 contiguous levels of the cervical spine. METHODS This study was a prospective, randomized, US FDA investigational device exemption pivotal trial of the Mobi-C cervical artificial disc conducted at 24 centers in the US. The primary clinical outcome was a composite measure of study success at 24 months. The comparative control treatment was ACDF using allograft bone and an anterior plate. A total of 330 patients were enrolled, randomized, and received study surgery. All patients were diagnosed with intractable symptomatic cervical DDD at 2 contiguous levels of the cervical spine between C-3 and C-7. Patients were randomized in a 2:1 ratio (TDR patients to ACDF patients). RESULTS A total of 225 patients received the Mobi-C TDR device and 105 patients received ACDF. At 24 months only 3.0% of patients were lost to follow-up. On average, patients in both groups showed significant improvements in Neck Disability Index (NDI) score, visual analog scale (VAS) neck pain score, and VAS arm pain score from preoperative baseline to each time point. However, the TDR patients experienced significantly greater improvement than ACDF patients in NDI score at all time points and significantly greater improvement in VAS neck pain score at 6 weeks, and at 3, 6, and 12 months postoperatively. On average, patients in the TDR group also maintained preoperative segmental range of motion at both treated segments immediately postoperatively and throughout the study period of 24 months. The reoperation rate was significantly higher in the ACDF group at 11.4% compared with 3.1% for the TDR group. Furthermore, at 24 months TDR demonstrated statistical superiority over ACDF based on overall study success rates. CONCLUSIONS The results of this study represent the first available Level I clinical evidence in support of cervical arthroplasty at 2 contiguous levels of the cervical spine using the Mobi-C cervical artificial disc. These results continue to support the use of cervical arthroplasty in general, but specifically demonstrate the advantages of 2-level arthroplasty over 2-level ACDF. Clinical trial registration no.: NCT00389597 (ClinicalTrials.gov).

Prospective, Randomized Comparison of Cervical Total Disk Replacement Versus Anterior Cervical Fusion: Results at 48 Months Follow-up

Study Design: This was a prospective, randomized, controlled multicenter trial. Objective: The purpose of this study was to compare clinical outcomes at 4-year follow-up of patients receiving cervical total disk replacement (TDR) with those receiving anterior cervical discectomy and fusion (ACDF). Summary of Background Data: ACDF has been the traditional treatment for symptomatic disk degeneration. Several studies found single-level TDR to be as safe and effective as ACDF at ≥2 years follow-up. Methods: Patients from 23 centers were randomized in a 2:1 ratio with 164 receiving the investigational device (Mobi-C Cervical Disc Prosthesis) and 81 receiving ACDF using an anterior plate and allograft. Patients were evaluated preoperatively and 6 weeks, 3, 6, 12, 18, 24, 36, and 48 months postoperatively. Outcome assessments included a composite success score, Neck Disability Index, visual analog scales assessing neck and arm pain, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent-segment degeneration. Results: The composite success rate was similar in the 2 groups at 48-month follow-up. Mean Neck Disability Index, visual analog scale, and SF-12 scores were significantly improved in early follow-up in both groups with improvements maintained throughout 48 months. On some measures, TDR had significantly greater improvement during early follow-up. At no follow-up were TDR scores significantly worse than ACDF scores. Subsequent surgery rate was significantly higher for ACDF compared with TDR (9.9% vs. 3.0%, P<0.05). Range of motion was maintained with TDR having a mean baseline value of 8 degrees compared with 10 degrees at 48 months. The incidence of adjacent-segment degeneration was significantly higher with ACDF at inferior and superior segments compared with TDR (inferior: 50% vs. 30%, P<0.025; superior: 53% vs. 34%, P<0.025). Conclusions: Significant improvements were observed in pain and function. TDR patients maintained motion and had significantly lower rates of reoperation and adjacent-segment degeneration compared with ACDF. This study supports the safety and efficacy of TDR in appropriately selected patients.

Polyethylene glycol hydrogel spinal sealant (DuraSeal Spinal Sealant) as an adjunct to sutured dural repair in the spine: results of a prospective, multicenter, randomized controlled study.

Study Design. A prospective, multicenter, randomized, two-arm, single-blind, investigational device exemption pivotal study. Objective. To assess the efficacy and the safety of a polyethylene glycol (PEG) hydrogel spinal sealant (DuraSeal Spinal Sealant) as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain a watertight dural closure in patients undergoing an intentional durotomy during spinal surgery. Summary of Background Data. If a watertight dural closure is not achieved, cerebrospinal fluid leak with associated complications may occur. The PEG hydrogel spinal sealant is an Food and Drug Administration (FDA)-approved adjunct to sutured dural repair in spine surgery. This synthetic, absorbable hydrogel sealant works in the presence of fluid, conforms to irregular surfaces, and demonstrates strong adherence and compliance to tissue, without interfering with underlying tissue visibility. Methods. A total of 158 patients were treated at 24 centers after they were randomized on the basis of an approximately 2:1 ratio (sealant:control); 102 received the PEG hydrogel spinal sealant and 56 received standard care. The primary end point was intraoperative watertight closure. Secondary end points included evaluations of postoperative cerebrospinal fluid leak, infection, and wound healing. Results. Patients treated with the PEG hydrogel spinal sealant had a significantly higher rate of watertight closure than the control (100% vs. 64.3%, P < 0.001). No statistical differences were seen in postoperative cerebrospinal fluid leak, infection, and wound healing. No neurologic deficits were seen attributable to the sealant. Conclusion. The PEG hydrogel spinal sealant evaluated in this study is safe and effective for providing watertight closure when used as an adjunct to sutured dural repair during spinal surgery. This readily available tool is superior to other standard of care technologies commonly used to achieve intraoperative watertight dural closure.

Occipitocervical fusion using recombinant human bone morphogenetic protein-2: adverse effects due to tissue swelling and seroma.

Study Design. Case presentation and literature review. Objective. To review the safety of using INFUSE bone graft (recombinant human bone morphogenetic protein-2 applied to an absorbable collagen sponge) in occipitocervical (OC) fusion. Summary of Background Data. Although INFUSE bone graft is currently approved for use in certain tibial fractures, oral maxillary procedures, and anterior lumbar interbody fusion, it has been extensively used “off-label” in posterolateral lumbar and anterior cervical fusions. INFUSE is highly effective in promoting cervical spine fusion via an anterior approach, but its potential role in promoting bony fusion in posterior cervical or OC fixation has not been studied. Methods. A 53-year-old woman with basilar invagination underwent OC fixation using INFUSE bone graft. Three days after surgery she experienced neurologic decline associated with significant tissue swelling and a large postoperative seroma under significant pressure. She made excellent recovery after reoperation and drainage. An extensive review of the literature was performed to propose a modified approach to the use of INFUSE in OC fixation. Results. Proper dosing and delivery of INFUSE for posterior cervical/OC fixation is not currently known. Previously published experience with anterior cervical fusion suggests that INFUSE can have potent inflammatory effects on paraspinal soft tissue. Conclusion. INFUSE should only be used for OC fixation in patients at elevated risk of nonunion. To prevent complications due to soft tissue swelling, consideration should be given to preventing direct exposure of INFUSE to paraspinal musculature, prolonged soft tissue drainage, and prophylactic treatment with perioperative steroid therapy.

Intraoperative fluoroscopy, portable X-ray, and CT: patient and operating room personnel radiation exposure in spinal surgery

BACKGROUND CONTEXT Intraoperative imaging is essential in spinal surgery to both determine the correct level and place implants safely. Surgeons have a variety of options: C-arm fluoroscopy (C-arm), portable X-ray (XR) radiography, and portable cone-beam computed tomography (O-arm). Although these modalities have their respective advantages and disadvantages, direct comparison of radiation exposure to either the patient or the operating room (OR) staff has not been made. PURPOSE To determine the amount of radiation exposure to patients and OR staff during spine surgery with C-arm, XR, and O-arm. STUDY DESIGN An experimental model to assess radiation exposure to OR staff and phantom patient during spine surgery. METHODS A plastic phantom was created to emulate patient volume and absorption scattering characteristics of a typical sized adult abdominal volume. Radiation exposure was measured with ion chamber dosimeters to determine entrance phantom and scatter exposures at common positions occupied by OR staff for C-arm, XR, and O-arm in typical image acquisition during spinal surgery. RESULTS Single lateral (LAT)/posterior-anterior entrance patient radiation exposure for C-arm was on average 116/102 mR, single-exposure XR for LAT/anterior-posterior (AP) was 3,435/2,160 mR, and single-exposure O-arm for LAT/AP was 4,360/5,220 mR. O-arm surface exposure LAT/AP was equivalent to 38/41 C-arm and 1.5/2.4 XR exposures. The surgeon and surgeon assistant had higher levels of scatter radiation for C-arm, followed by O-arm and XR. For the LAT C-arm acquisition, a 7.7-fold increase in radiation exposure was measured on the X-ray tube side compared with the detector side. The anesthesiologist scatter radiation level for a single acquisition was highest for O-arm, followed by XR and C-arm. The radiologic technologist scatter radiation level was highest for XR, followed by O-arm and fluoroscopy. Overall radiation exposure to OR staff was less than 4.4 mR for a single acquisition in all modalities. CONCLUSIONS Assessment of radiation risk to the patient and OR staff should be part of the decision for utilization of any specific imaging modality during spinal surgery. This study provides the surgeon with information to better weigh the risks and benefits of each imaging modality.

Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up

Introduction There is increasing interest in the role of cervical total disc replacement (TDR) as an alternative to anterior cervical discectomy and fusion (ACDF). Multiple prospective randomized studies with minimum 2 year follow-up have shown TDR to be at least as safe and effective as ACDF in treating symptomatic degenerative disc disease at a single level. The purpose of this study was to compare outcomes of cervical TDR using the Mobi-C® with ACDF at 5-year follow-up. Methods This prospective, randomized, controlled trial was conducted as a Food and Drug Administration regulated Investigational Device Exemption trial across 23 centers with 245 patients randomized (2:1) to receive TDR with Mobi-C® Cervical Disc Prosthesis or ACDF with anterior plate and allograft. Outcome assessments included a composite overall success score, Neck Disability Index (NDI), visual analog scales (VAS) assessing neck and arm pain, Short Form-12 (SF-12) health survey, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent segment degeneration. Results The 60-month follow-up rate was 85.5% for the TDR group and 78.9% for the ACDF group. The composite overall success was 61.9% with TDR vs. 52.2% with ACDF, demonstrating statistical non-inferiority. Improvements in NDI, VAS neck and arm pain, and SF-12 scores were similar between groups and were maintained from earlier follow-up through 60 months. There was no significant difference between TDR and ACDF in adverse events or major complications. Range of motion was maintained with TDR through 60 months. Device-related subsequent surgeries (TDR: 3.0%, ACDF: 11.1%, p<0.02) and adjacent segment degeneration at the superior level (TDR: 37.1%, ACDF: 54.7%, p<0.03) were significantly lower for TDR patients. Conclusions Five-year results demonstrate the safety and efficacy of TDR with the Mobi-C as a viable alternative to ACDF with the potential advantage of lower rates of reoperation and adjacent segment degeneration, in the treatment of one-level symptomatic cervical degenerative disc disease. Clinical Relevance This prospective, randomized study with 5-year follow-up adds to the existing literature indicating that cervical TDR is a viable alternative to ACDF in appropriately selected patients. Level of Evidence This is a Level I study.

Cost-effectiveness of Cervical Total Disc Replacement vs Fusion for the Treatment of 2-Level Symptomatic Degenerative Disc Disease

IMPORTANCE Cervical total disc replacement (CTDR) was developed to treat cervical spondylosis, while preserving motion. While anterior cervical discectomy and fusion (ACDF) has been the standard of care for 2-level disease, a randomized clinical trial (RCT) suggested similar outcomes. Cost-effectiveness of this intervention has never been elucidated. OBJECTIVE To determine the cost-effectiveness of CTDR compared with ACDF. DESIGN, SETTING, AND PARTICIPANTS Data were derived from an RCT that followed up 330 patients over 24 months. The original RCT consisted of multi-institutional data including private and academic institutions. Using linear regression for the current study, health states were constructed based on the stratification of the Neck Disability Index and a visual analog scale. Data from the 12-item Short-Form Health Survey questionnaires were transformed into utilities values using the SF-6D mapping algorithm. Costs were calculated by extracting Diagnosis-Related Group codes from institutional billing data and then applying 2012 Medicare reimbursement rates. The costs of complications and return-to-work data were also calculated. A Markov model was built to evaluate quality-adjusted life-years (QALYs) for both treatment groups. The model adopted a third-party payer perspective and applied a 3% annual discount rate. Patients included in the original RCT had to be diagnosed as having radiculopathy or myeloradiculopathy at 2 contiguous levels from C3-C7 that was unresponsive to conservative treatment for at least 6 weeks or demonstrated progressive symptoms. MAIN OUTCOMES AND MEASURES Incremental cost-effectiveness ratio of CTDR compared with ACDF. RESULTS A strong correlation (R2 = 0.6864; P < .001) was found by projecting a visual analog scale onto the Neck Disability Index. Cervical total disc replacement had an average of 1.58 QALYs after 24 months compared with 1.50 QALYs for ACDF recipients. Cervical total disc replacement was associated with

Expandable Versus Nonexpandable Cages for Thoracolumbar Burst Fracture

2139 greater average cost. The incremental cost-effectiveness ratio of CTDR compared with ACDF was