Comparison of transforaminal and posterior lumbar interbody fusion outcomes in patients receiving a novel allograft versus rhBMP-2: a radiographic and patient-reported outcomes analysis.

OBJECTIVE: Recombinant human bone morphogenetic protein-2 (rhBMP-2) has been demonstrated to achieve the highest rates of arthrodesis in multilevel lumbar fusion but is also associated with possible perioperative morbidity. A novel allograft (OSTEOAMP) is a differentiated allograft that retains growth factors supporting bone healing. The authors sought to compare the clinical and radiographic outcomes of rhBMP-2 and the novel allograft in lumbar interbody arthrodesis to determine if the latter may be a safer and equally effective alternative to rhBMP-2 for single- and multilevel posterior or transforaminal lumbar interbody fusion (PLIF or TLIF). METHODS: Patients who underwent single- or multilevel TLIF or PLIF using either OSTEOAMP or rhBMP-2 at the authors' institution over a 2-year period were prospectively followed for 12 months. Healthcare utilization, safety measures, patient satisfaction, physical disability (measured on the Oswestry Disability Index [ODI]), back and leg pain (on the numeric rating scale [NRS]), quality of life (on the EQ-5D scale), and return to work (RTW) were prospectively recorded. For purposes of this study, this consecutive series was retrospectively analyzed and pseudarthrosis rates were assessed at 2 years of follow-up. All patients (100%) had both 12-month patient-reported outcome follow-up and 24-month clinical and radiographic follow-up. RESULTS: One thousand one hundred fifty-four patients (654 treated with OSTEOAMP, 500 with rhBMP-2) were prospectively enrolled in the institutional registry. After propensity score matching, there were no significant baseline differences between 330 novel allograft and 330 rhBMP-2 cases. Perioperative morbidity and 90-day hospital readmission (3.3% vs 2.4%, p = 0.485) did not significantly differ between the novel allograft and the rhBMP-2 cases. At the 2-year follow-up, symptomatic pseudarthrosis requiring revision surgery occurred in 8 patients (2.4%) with OSTEOAMP and 6 patients (1.8%) with rhBMP-2 (p = 0.589). The overall fusion rate at 2 years was similar between groups (p = 0.213). Both groups showed significant and equivalent improvement in patient-reported outcome measures (PROMs) from baseline to 12-month follow-up, with no significant difference in 1-year mean NRS leg pain score (2.5 vs 2.7), ODI (25 vs 26), quality-adjusted life years (0.73 vs 0.73), satisfaction (83% vs 80%), or RTW (6.6 vs 7 weeks). CONCLUSIONS: In the authors' institutional experience, OSTEOAMP is a clinically viable substitute for rhBMP-2 for single- and multilevel lumbar fusion. This novel allograft provides clinically effective arthrodesis and improvements in PROMs comparable to rhBMP-2 with a similar safety profile. Additional indications and outcome assessment in longitudinal studies are needed to further characterize this allogeneic graft.

Does type of bone graft matter? A retrospective review of the use of biological bone grafts in patients undergoing elective 1-3 level spinal interbody fusion.

OBJECTIVE: There is a lack of strong evidence for use of expensive bone substitutes. This study compares perioperative data and patient reported quality-of-life outcomes across the varied types of bone graft extenders. The study analyzes the existing Quality and Outcomes Database and evaluates patient reported outcomes for 1-3 level lumbar fusion procedures comparing across different types of biologics bone graft. METHODS: We retrospectively analyzed a prospectively collected data registry. Bone graft implant data were collected and grouped into the following categories: (1) Autograft with basic allograft (2) Enhanced, synthetic, or cellular allograft (3) Use of BMP. Preoperative and 1 year patient reported outcomes and perioperative data from the prospective collected registry were analyzed. RESULTS: There were 384 patients included in this study. There were 168 (43.8%) patients in group 1, 133 (34.6%) patients in group 2, and 83 (21.6%) in group 3. There were no group differences in baseline or 1 year back pain, leg pain, ODI, or EQ-5D. The GLM Repeated Measures results indicate a significant difference within each of the three groups between the preoperative and postoperative measures for back pain, leg pain, ODI, and EQ-5D. The change over time was not significantly different between the groups. CONCLUSIONS: Bone graft extenders are a significant contributor to the cost of lumbar fusion. This study demonstrates no difference in preoperative, and 1 year patient reported outcomes between the three groups. There was no significant difference in rate of reoperations across the three groups.

Mental health comorbidities in workers' compensation patients and the effect on pain, disability, quality of life, and return to work after lumbar spine surgery.

OBJECTIVE: The impact of mental health comorbidities on outcomes after lumbar spine surgery in workers' compensation (WC) patients has not been robustly explored. The goal of this study was to examine the impact of mental health comorbidities on pain, disability, quality of life, and return to work after lumbar spine surgery in WC patients. METHODS: A nationwide, prospective surgical outcomes registry (National Neurosurgery Quality Outcomes Database [N2QOD]) was queried for all patients who underwent 1- to 4-level lumbar decompression and/or fusion from 2012 to 2021. Patients were stratified on the basis of compensation status into non-WC (25,507) and WC (1018) cohorts. Baseline demographic data, perioperative safety data, and patient-reported outcome measures were compared between groups. The WC cohort was further subdivided on the basis of mental health status into patients with anxiety and depression (n = 107) and those without anxiety and depression (n = 911). Propensity matching was used to generate parity between these subgroups, generating 214 patients (107 pairs) for analysis. Perioperative safety, facility utilization, 1-year patient-reported outcomes (back and leg pain, disability, and quality of life), and return to work were measured as a function of WC and mental health comorbidity status. RESULTS: A total of 26,525 patients (25,507 non-WC and 1018 WC) who underwent 1- to 4-level lumbar spine surgery were reviewed. WC patients were younger, healthier (lower American Society of Anesthesiologists class), more likely to be minorities, less educated, and more likely to smoke and had greater baseline back pain, disability, and quality of life compared to non-WC patients. The prevalence of anxiety and depression was similar between groups (11%). WC patients had worse outcomes for all measures and lower rates of return to work compared to non-WC patients. WC patients with anxiety and depression demonstrated even greater disparities in all outcomes. After propensity matching, WC patients with anxiety and depression continued to demonstrate significantly worse outcomes in comparison to WC patients without anxiety and depression. CONCLUSIONS: Disparities in outcomes after lumbar spine surgery in WC patients are exacerbated in patients with anxiety and depression. WC patients with mental health comorbidities receive the least benefit from lumbar spine surgery and may represent the most vulnerable subset of patients with spine pathology. Addressing mental health comorbidities preoperatively may represent an opportunity for valuable resource allocation and surgical optimization in the WC population.

Patent bibliometrics in spinal deformity: the first bibliometric analysis of spinal deformity's technological literature.

PURPOSE: Bibliometric analyses have gained popularity for studying scientific literature, but their application to evaluate technological literature (patents) remains unexplored. We conducted a bibliometric analysis on the top 100 most-cited patents in scoliosis surgery. METHODS: Multiple databases were queried using The Lens to identify the top 100 scoliosis surgery patents, which were selected based on forward patent citations. These patents were then categorized into 8 groups based on technological descriptors and assessed based on various factors including earliest priority date, year issued, and expiration status. RESULTS: The top 100 most-cited patents included technology underlying anterolateral tethering and distraction systems (n = 11), posterior tethering and distraction systems (n = 23), posterior segmental bone anchor and rod engagement systems (n = 29), interbody devices (n = 10), biological and electrophysiological agents for scoliosis treatment and/or improved arthrodesis (n = 8), intraoperative arthroplasty devices (n = 5), orthotic devices (n = 12), and implantable devices for non-invasive, postoperative alterations of skeletal alignment (n = 2). Seventy-five patents were expired, 21 are still active, and 4 were listed as inactive. The late 1970s and early 2000s saw increased numbers of patent filings. Demonstrated trends showed no meaningful correlation between patent rank and earliest priority date (linear trendline y = 0.2648x - 477.27; R2 = 0.0114), while a very strong correlation was found between patent rank and citations per year (power trendline y = 118.82x--0.83; R2 = 0.8983). CONCLUSION: Patent bibliometric analyses in the field of spinal deformity surgery provide a means to assess past advancements, better understand what it takes to make a difference in the field, and to potentially facilitate the development of innovative technologies in the future. The method described is a reliable and reproducible technique for evaluating technological literature in our field.

Microendoscopic Posterior Cervical Laminoforaminotomy for C4 Radiculopathy.

OBJECTIVE: Cervical microendoscopic laminoforaminotomy (MELF) has been proven to be an effective, motion preserving procedure for the surgical treatment of cervical radiculopathy. Cervical 4 (C4) radiculopathies are often unrecognized by the initial evaluating physician and may be misdiagnosed as axial neck pain. In this study, we compare MELF to anterior cervical disk fusion (ACDF) for C4 radiculopathy in the largest series of minimally invasive foraminotomy for C4 radiculopathy to date. METHODS: This is a single-institution retrospective chart review of 42 cases for C4 radiculopathy, 21 MELF and 21 ACDF. Primary outcome measures were length of surgery, length of hospital stay, and time to return to work. Secondary outcome measures were visual analog scale (VAS) neck pain and reoperation rate. RESULTS: All patients were diagnosed with a unilateral C4 radiculopathy using magnetic resonance imaging or steroid injections. The length of surgery and length of hospital stay were significantly decreased in the MELF group compared with ACDF. VAS neck pain significantly decreased for patients in both groups, but the difference between MELF and ACDF was not statistically significant. There were no major complications. No patient underwent revision at the index level or adjacent levels in the MELF group. CONCLUSIONS: We demonstrate that C4 radiculopathy can be identified with appropriate history, physical examination, and targeted nerve root injections. When identified, these radiculopathies that fail conservative therapy can be effectively treated with cervical microendoscopic laminoforaminotomy, with comparable outcomes to ACDF. The length of surgery and length of stay are reduced when compared with ACDF.

Effect of workers' compensation status on pain, disability, quality of life, and return to work after anterior cervical discectomy and fusion: a 1-year propensity score-matched analysis.

OBJECTIVE: Patients with workers' compensation (WC) claims are reported to demonstrate poorer surgical outcomes after lumbar spine surgery. However, outcomes after anterior cervical discectomy and fusion (ACDF) in WC patients remain debatable. The authors aimed to compare outcomes between a propensity score-matched population of WC and non-WC patients who underwent ACDF. METHODS: Patients who underwent 1- to 4-level ACDF were retrospectively reviewed from the prospectively maintained Quality Outcomes Database (QOD). After propensity score matching, 1-year patient satisfaction, physical disability (Neck Disability Index [NDI]), pain (visual analog scale [VAS]), EQ-5D, and return to work were compared between WC and non-WC cohorts. RESULTS: A total of 9957 patients were included (9610 non-WC and 347 WC patients). Patients in the WC cohort were significantly younger (50 ± 9.1 vs 56 ± 11.4 years, p < 0.001), less educated, and were more frequently male, non-Caucasian, and active smokers (29.1% vs 18.1%, p < 0.001), with greater baseline VAS and NDI scores and poorer quality of life (p < 0.001). One-year postoperative improvements in VAS, NDI, EQ-5D, and return-to-work rates and satisfaction were all significantly worse for WC compared with non-WC patients. After adjusting for baseline differences via propensity score matching, WC versus non-WC patients continued to demonstrate worse 3- and 12-month VAS neck pain and NDI (p = 0.010), satisfaction (χ2 = 4.03, p = 0.045), and delayed return to work (9.3 vs 5.7 weeks, p < 0.001). CONCLUSIONS: WC status was associated with greater 1-year residual disability and axial pain along with delayed return to work, without any difference in quality of life despite having fewer comorbidities and being a younger population. Further studies are needed to determine the societal impact that WC claims have on healthcare delivery in the setting of ACDF.

Minimally Invasive Transforaminal Lumbar Interbody Fusion in the Ambulatory Surgery Center Versus Inpatient Setting: A 1-Year Comparative Effectiveness Analysis.

BACKGROUND: Ambulatory surgery centers (ASCs) have emerged as an alternative setting for surgical care as part of the national effort to lower health care costs. The literature regarding the safety of minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) in the ASC setting is limited to few small case series. OBJECTIVE: To assess the safety and efficacy of MIS TLIF performed in the ASC vs inpatient hospital setting. METHODS: A total of 775 patients prospectively enrolled in the Quality Outcomes Database undergoing single-level MIS TLIF at a single ASC (100) or the inpatient hospital setting (675) were compared. Propensity matching generated 200 patients for analysis (100 per cohort). Demographic data, resource utilization, patient-reported outcome measures (PROMs), and patient satisfaction were assessed. RESULTS: There were no significant differences regarding baseline demographic data, clinical history, or comorbidities after propensity matching. Only 1 patient required inpatient transfer from the ASC because of intractable pain. All other patients were discharged home within 23 hours of surgery. The rates of 90-day readmission (2.0%) and reoperation (0%) were equivalent between groups. Both groups experienced significant improvements in all PROMs (Oswestry Disability Index, EuroQol-5D, back pain, and leg pain) at 3 months that were maintained at 1 year. PROMs did not differ between groups at any time point. Patient satisfaction was similar between groups at 3 and 12 months after surgery. CONCLUSION: In carefully selected patients, MIS TLIF may be performed safely in the ASC setting with no statistically significant difference in safety or efficacy in comparison with the inpatient setting.

Anterior Cervical Discectomy and Fusion Versus Microendoscopic Posterior Cervical Foraminotomy for Unilateral Cervical Radiculopathy: A 1-Year Cost-Utility Analysis.

BACKGROUND: Anterior cervical discectomy and fusion (ACDF) and posterior cervical foraminotomy (PCF) are the most common surgical approaches for medically refractory cervical radiculopathy. Rigorous cost-effectiveness studies comparing ACDF and PCF are lacking. OBJECTIVE: To assess the cost-utility of ACDF vs PCF performed in the ambulatory surgery center setting for Medicare and privately insured patients at 1-year follow-up. METHODS: A total of 323 patients who underwent 1-level ACDF (201) or PCF (122) at a single ambulatory surgery center were compared. Propensity matching generated 110 pairs (220 patients) for analysis. Demographic data, resource utilization, patient-reported outcome measures, and quality-adjusted life-years were assessed. Direct costs (1-year resource use × unit costs based on Medicare national allowable payment amounts) and indirect costs (missed workdays × average US daily wage) were recorded. Incremental cost-effectiveness ratios were calculated. RESULTS: Perioperative safety, 90-day readmission, and 1-year reoperation rates were similar between groups. Both groups experienced significant improvements in all patient-reported outcome measures at 3 months that was maintained at 12 months. The ACDF cohort had a significantly higher preoperative Neck Disability Index and a significantly greater improvement in health-state utility (ie, quality-adjusted life-years gained) at 12 months. ACDF was associated with significantly higher total costs at 1 year for both Medicare ($11 744) and privately insured ($21 228) patients. The incremental cost-effectiveness ratio for ACDF was $184 654 and $333 774 for Medicare and privately insured patients, respectively, reflecting poor cost-utility. CONCLUSION: Single-level ACDF may not be cost-effective in comparison with PCF for surgical management of unilateral cervical radiculopathy.

Effect of workers' compensation status on pain, disability, quality of life, and return to work after lumbar spine surgery: a 1-year propensity-matched analysis.

OBJECTIVE: Workers' compensation (WC) and litigation have been shown to adversely impact prognoses in a vast range of health conditions. Low-back pain is currently the most frequent reason for WC claims. The objective of this study was to conduct the largest propensity-matched comparison of outcomes between patients with WC and non-WC status who underwent lumbar spinal decompression with and without fusion. METHODS: Complete data sets for patients who underwent 1- to 4-level lumbar spinal fusion or decompression alone were retrospectively retrieved from the Quality Outcomes Database (QOD), which included 1-year patient-reported outcomes from more than 200 hospital systems collected from 2012 to 2021. Population demographics, perioperative safety, facility utilization, patient satisfaction, disability, pain, EQ-5D quality of life, and return to work (RTW) rates were compared between cohorts for both subgroups. Statistical significance was set at p < 0.05. RESULTS: There were 29,652 patients included in the study. Laminectomy was performed in 16,939 with non-WC status and in 615 with WC, whereas fusion was performed in 11,767 with non-WC status and in 331 with WC. WC patients were more frequently male, a minority race, younger, less educated, more frequently a smoker, had a healthier American Society of Anesthesiologists grade, and with greater baseline visual analog scale (VAS) and Oswestry Disability Index (ODI) scores (p < 0.001). One-year postoperative improvements in VAS, ODI, quality-adjusted life years (QALYs), RTW rates, and satisfaction were all significantly worse for WC versus non-WC patients for both procedures. After adjusting for baseline differences via propensity matching, WC versus non-WC patients continued to demonstrate worse 3- and 12-month VAS and ODI scores, reduced 12-month QALY gain, and delayed RTW after both procedure types. CONCLUSIONS: WC status was associated with significantly greater residual disability and pain postoperatively, a lower quality of life, and delayed RTW. Utilizing resources to identify the negative influences on outcomes for WC patients may be valuable in preoperative optimization and could yield better outcomes in these patients.

Feasibility and Safety of Microendoscopic Posterior Cervical Foraminotomy in an Ambulatory Surgery Center: A Longitudinal Experience with 1000 Cases.

OBJECTIVE: Ambulatory surgery centers (ASCs) have become an increasingly attractive setting for spine surgery in recent decades. Although posterior cervical foraminotomy (PCF) is widely performed in ASCs, there are no studies supporting the safety of this practice. We aimed to demonstrate the feasibility and safety of microendoscopic (MED)-PCF in a large cohort of patients at a freestanding ASC. METHODS: Consecutive patients undergoing MED-PCF for unilateral cervical radiculopathy at a single freestanding ASC from January 2013 to December 2020 were queried. Standard demographic and perioperative data were collected. Outcomes included need for inpatient transfer, perioperative complications, 30-day readmission, 30-day reoperation, and clinical improvement according to the Odom criteria. RESULTS: A total of 1106 patients underwent MED-PCF during the study period. Mean age was 53.3 ± 10.3 years. Most patients underwent decompression at C5-6 (31.4%) or C6-7 (51.9%). Approximately 10% underwent surgery at multiple levels. Mean operative time was 40.0 ± 16.4 minutes. There were no intraoperative or immediate postoperative complications. All patients were discharged home within a few hours of surgery. The rates of 30-day readmission (0.81%) and reoperation (0.36%) were exceedingly low. Nearly 3 quarters of patients (73.7%) achieved a good or excellent clinical outcome (73.7%) according to the Odom criteria. CONCLUSIONS: MED-PCF can be performed in a freestanding ASC with exceedingly low rates of perioperative complications and short-term readmission or reoperation. Our findings support the ongoing migration of PCF from the hospital to the ambulatory setting. Future studies assessing patient-reported outcomes and long-term reoperation rates are necessary.

Anterior Cervical Discectomy and Fusion in the Ambulatory Surgery Center Versus Inpatient Setting: One-Year Cost-Utility Analysis.

STUDY DESIGN: Retrospective analysis of prospectively collected data. OBJECTIVE: Assess the cost-utility of anterior cervical discectomy and fusion (ACDF) performed in the ambulatory surgery center (ASC) versus inpatient hospital setting for Medicare and privately insured patients at one-year follow-up. SUMMARY OF BACKGROUND DATA: Outpatient ACDF has gained popularity due to improved safety and reduced costs. Formal cost-utility studies for ambulatory versus inpatient ACDF are lacking, precluding an accurate assessment of cost-effectiveness. MATERIALS AND METHODS: A total of 6504 patients enrolled in the Quality Outcomes Database (QOD) undergoing one-level to two-level ACDF at a single ASC (520) or the inpatient hospital setting (5984) were compared. Propensity matching generated 748 patients for analysis (374 per cohort). Demographic data, resource utilization, patient-reported outcome measures, and quality-adjusted life-years (QALYs) were assessed. Direct costs (1-year resource use×unit costs based on Medicare national allowable payment amounts) and indirect costs (missed workdays×average US daily wage) were recorded. Incremental cost-effectiveness ratios were calculated. RESULTS: Complication rates and improvements in patient-reported outcome measures and QALYs were similar between groups. Ambulatory ACDF was associated with significantly lower total costs at 1 year for Medicare ($5879.46) and privately insured ($12,873.97) patients, respectively. The incremental cost-effectiveness ratios for inpatient ACDF was $3,674,662 and $8,046,231 for Medicare and privately insured patients, respectively, reflecting unacceptably poor cost-utility. CONCLUSION: Inpatient ACDF is associated with significant increases in total costs compared to the ASC setting without a safety, outcome, or QALY benefit. The ASC setting is a dominant option from a health economy perspective for first-time one-l to two-level ACDF in select patients compared to the inpatient hospital setting.

Minimally Invasive Transforaminal Lumbar Interbody Fusion in the Ambulatory Setting with an Enhanced Recovery After Surgery Protocol.

OBJECTIVE: Enhanced Recovery After Surgery (ERAS) is a multidisciplinary approach to surgical care that aims to improve outcomes and reduce costs. Its application to spine surgery has been increasing in recent years, with a notable focus on lumbar fusion. This study describes the development, implementation, and outcomes of the first ERAS pathway for ambulatory spine surgery and the largest ambulatory minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) series to date. METHODS: A comprehensive protocol for ambulatory lumbar fusion is described, including patient selection criteria, a multimodal analgesia regimen, and discharge assessment. Consecutive patients undergoing 1- or 2-level MIS TLIF using the described protocol at a single ambulatory surgery center (ASC) over a five-year period were queried. RESULTS: A total of 215 patients underwent ambulatory MIS TLIF over the study period. There were no intraoperative or immediate postoperative complications. All but one patient (99.5%) were discharged home from the ASC. Almost three-quarters (71.2%) were discharged on the day of surgery. Thirty- and 90-day readmission rates were 1.4% and 2.8%, respectively. Only one readmission (0.5%) was for intractable back pain. There were no reoperations or mortalities within 90 days of surgery. CONCLUSIONS: MIS TLIF can be performed safely in a freestanding ambulatory surgery center with minimal perioperative and short-term morbidity. The addition of comprehensive ERAS protocols to the ambulatory setting can promote the transition of fusion procedures to this lower cost environment in an effort to provide higher value care.

Is Thoracic Paddle Lead Spinal Cord Stimulator Implantation Safe in an Ambulatory Surgery Center?

OBJECTIVE: Spinal cord stimulation is an effective treatment modality for chronic pain. Although percutaneous leads are commonly placed in the outpatient setting, paddle leads are typically implanted in the inpatient setting. Given the substantial cost savings associated with the ambulatory setting, we aimed to demonstrate the feasibility and safety of thoracic paddle lead implantation in a freestanding ambulatory surgery center (ASC). METHODS: Consecutive patients undergoing thoracic paddle lead implantation at a single freestanding ASC from January 2015 to December 2020 were queried. Demographic, perioperative, and outcome data were collected. Primary outcomes were incidence of intraoperative or immediate postoperative complications and need for inpatient transfer. Secondary outcomes included readmission at 30 and 90 days and reoperation at 30 days, 90 days, and 1 year. RESULTS: A total of 46 patients underwent ambulatory thoracic paddle lead implantation over the study period. Two patients (4.3%) suffered an immediate postoperative complication requiring return to surgery at the ASC-one for an epidural hematoma, and one for a flank hematoma. All but one patient (97.8%) were discharged home on the day of surgery. The overall 30- and 90-day readmission rates were 4.3% and 6.5%, respectively. One patient (2.2%) required reoperation for a mechanical complication. No device-related infections were noted during the follow-up period. CONCLUSIONS: Thoracic laminotomy for paddle lead spinal cord stimulator implantation can be performed in a freestanding ASC with complication rates comparable to the hospital setting. Future comparative studies that assess clinical outcomes and cost are necessary to determine the cost-effectiveness of the ambulatory setting.

Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis.

OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial. METHODS: The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory. RESULTS: A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4-5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85°) to 24 months (3.86°). CONCLUSIONS: This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.

Percutaneous, Navigated Minimally Invasive Posterior Cervical Pedicle Screw Fixation.

BACKGROUND: Cervical pedicle screws provide significant biomechanical advantage but can be technically challenging and associated with morbid exposure. Improvements in intraoperative navigation guidance and instrumentation have made feasible this biomechanically robust, but technically challenging procedure. We present our initial experience with minimally invasive (MIS) percutaneous pedicle screw fixation in the cervical atlantoaxial and subaxial spine. METHODS: A retrospective review was performed on 27 cases that involved a novel MIS percutaneous cervical pedicle screw technique. Small lateral skin incisions were made bilaterally on the neck using intraoperative navigation guidance. Subsequently, navigated, percutaneous screws were placed using the Proficient Minimally Invasive System (PROMIS; Spine Wave, Shelton, CT). Computed tomography (CT)-guided navigation was used for cervical pedicle screw placement with subsequent placement of percutaneous rods. RESULTS: Indications for surgery included type II odontoid fractures, subaxial fracture dislocations and burst fracture, metastatic pathological burst fracture, and degenerative spondylosis with stenosis. There were 15 men and 12 women, with an average age 63.5 years. Follow-up ranged from 3 to 24 months (average = 16.7 months). One screw was revised intraoperatively. Two patients (7.7%) required reoperation, 1 patient required repositioning of a C5 pedicle screw, and 1 suffered a C7 body fracture. No nerve root injury, spinal cord injury, or vertebral artery injuries were reported. CONCLUSIONS: Percutaneous cervical pedicle screw fixation is a feasible and safe technique when performed with CT-guided intraoperative navigation techniques. Cervical pedicle screw fixation provides a biomechanically superior construct in comparison with a lateral mass technique. In addition, the lack of paraspinal muscle disruption preserves important stabilizers of the posterior ligamentous complex and may reduce wound-healing issues in high-risk cases (eg, trauma patients). Although the current role for percutaneous instrumentation is relatively narrow, the advancement of MIS posterior cervical techniques may provide expanded opportunities in the future.

Case Presentation of Sagittal Balance.

Sagittal balance is an important concept in spinal coronal and kyphotic deformity correction. Sagittal alignment/lumbar lordosis is increasingly recognized and discussed in terms of surgical outcomes. Positive sagittal balance can lead to development of iatrogenic kyphosis, flatback syndrome, adjacent level degeneration, and junctional kyphosis. This concept is no longer associated only with deformity. Spine surgeons have learned that sagittal alignment/lumbar lordosis is very important even in 1-level or 2-level interbody fusion procedures, and that it can be attained, maintained, or lost during any procedure, resulting in complications.

Prospective randomized study of cervical arthroplasty and anterior cervical discectomy and fusion with long-term follow-up: results in 74 patients from a single site.

OBJECT: The purpose of this study was to evaluate the long-term results of cervical total disc replacement (TDR) and anterior cervical discectomy and fusion (ACDF) in the treatment of single-level cervical radiculopathy. METHODS: The results of 2 separate prospective, randomized, US FDA Investigational Device Exemption pivotal trials (Bryan Disc and Kineflex|C) from a single investigational site were combined to evaluate outcomes at long-term follow-up. The primary clinical outcome measures included the Neck Disability Index (NDI), visual analog scale (VAS), and neurological examination. Patients were randomized to receive cervical TDR in 2 separate prospective, randomized studies using the Bryan Disc or Kineflex|C cervical artificial disc compared with ACDF using structural allograft and an anterior plate. Patients were evaluated preoperatively; at 6 weeks; at 3, 6, and 12 months; and then yearly for a minimum of 48 months. Plain radiographs were obtained at each study visit. RESULTS: A total of 74 patients were enrolled and randomly assigned to either the cervical TDR (n = 41) or ACDF (n = 33) group. A total of 63 patients (86%) completed a minimum of 4 years follow-up. Average follow-up was 6 years (72 months) with a range from 48 to 108 months. In both the cervical TDR and ACDF groups, mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the minimum 48-month follow-up (p < 0.001). Similarly, the median VAS pain scores improved significantly by 6 weeks and remained significantly improved throughout the minimum 48-month follow-up (p < 0.001). There were no significant differences between groups in mean NDI or median VAS scores. The range of motion (ROM) in the cervical TDR group remained significantly greater than the preoperative mean, whereas the ROM in the ACDF group was significantly reduced from the preoperative mean. There was significantly greater ROM in the cervical TDR group compared with the ACDF group. There were 3 reoperations (7.3%) at index or adjacent levels in the cervical TDR group; all were cervical laminoforaminotomies. There were 2 adjacent-level reoperations in the cervical TDR group (4.9%). There was 1 reoperation (3.0%) in the ACDF group at an index or adjacent level (a second ACDF at the adjacent level). There was no statistically significant difference in overall reoperation rate or adjacent-level reoperation rate between groups. CONCLUSIONS: Both cervical TDR and ACDF groups showed excellent clinical outcomes that were maintained over long-term follow-up. Both groups showed low index-level and adjacent-level reoperation rates. Both cervical TDR and ACDF appear to be viable options for the treatment of single-level cervical radiculopathy.

Case report: peptic ulcer disease in a professional athlete.

Peptic ulcer disease (PUD) is a common problem that affects 4 million people in the United States. Although its prevalence has not been studied in the athletic population, one would suspect PUD would affect athletes at a similar rate or higher based on the predispositions to certain risk factors of this disease. This case report addresses the particular predispositions for PUD in a professional football athlete.

Gamma Knife surgery targeting the resection cavity of brain metastasis that has progressed after whole-brain radiotherapy.

OBJECT: Salvage treatment of large, symptomatic brain metastases after failure of whole-brain radiotherapy (WBRT) remains challenging. When these lesions require resection, there are few options to lower expected rates of local recurrence at the resection cavity margin. The authors describe their experience in using Gamma Knife surgery (GKS) to target the resection cavity in patients whose tumors had progressed after WBRT. METHODS: The authors retrospectively identified 143 patients in whom GKS had been used to target a brain metastasis resection cavity between 2000 and 2005. Seventy-nine of these patients had undergone WBRT prior to resection and GKS. The median patient age was 53 years, and the median prescribed dose was 18 Gy (range 8-24 Gy), with resection cavities of relatively larger volume (> 15 cm3). The GKS dose was prescribed at the 40 to 95% isodose contour (mode 50%). Local recurrence within 1 cm of the treatment volume occurred in four (5.1%) of 79 cases. The median duration of time to local recurrence was 6.1 months (range 2-13 months). The median duration of time to occurrence of distant metastases following GKS of the resection cavity was 10.8 months (range 2-86 months). Carcinomatous meningitis developed in four (5.1%) of 79 cases. Symptomatic radionecrosis requiring surgical treatment occurred in three (3.8%) of 79 cases. The median duration of survival following GKS of the resection cavity was 69.6 weeks. The median 2- and 5-year survival rates were 20.2 and 6.3%, respectively. CONCLUSIONS: When metastases progress after WBRT and require resection, GKS targeting the resection cavity is a viable strategy. In 75 (94.9%) of 79 cases, GKS of the resection cavity in patients in whom WBRT had failed appears to have achieved its goal of local disease control.

Indications for circumferential surgery for cervical spondylotic myelopathy.

BACKGROUND CONTEXT: The surgical management of patients with cervical spondylotic myelopathy (CSM) remains challenging. PURPOSE: To review the indications, techniques, and results of circumferential fusion for CSM. CONCLUSION: Circumferential decompression and stabilization with instrumentation is a viable option to treat selected complex cervical spine disorders. It provides immediate stabilization of the spine, decreases anterior graft and instrumentation failure, and can obviate the need for postoperative halo immobilization.