Segmental Motion of Cervical Arthroplasty Leads to Decreased Adjacent-Level Degeneration: Analysis of the 7-Year Postoperative Results of a Multicenter Randomized Controlled Trial.

BACKGROUND: Cervical artificial disc replacement (C-ADR) has become a common and accepted surgical treatment for many patients with cervical disc degeneration/herniation and radiculopathy who have failed nonoperative treatment. Midterm follow-up studies of the original investigational device exemption trials comparing C-ADR to traditional anterior cervical discectomy and fusion (ACDF) have revealed C-ADR patients have less adjacent-level disease and fewer reoperations at 5 to 7 years. The purpose of this study was to examine the relationship of radiographic adjacent-level disease (R-ALD) with the amount of index-level segmental range of motion (ROM) in C-ADR patients using the long-term follow-up data from the ProDisc-C investigational device exemption trial. METHODS: This was a post hoc analysis of a 1:1 randomized controlled trial. The initial previously described Food and Drug Administration-approved 2-year study was extended, and consenting patients in the original study were followed at annual intervals up to 7 years. Logistic regression was used to assess any progression in adjacent-level disease (ALD). Ordinal logistic regression was also used to assess the relationship between any progressive R-ALD and final flexion extension (F/E) ROM in C-ADR patients. Spearman's rank-order correlation was used when R-ALD was kept as an ordinal variable to assess the same relationship. RESULTS: At the last follow-up visit, the rate of progressive R-ALD was significantly higher in ACDF patients than in C-ADR patients. When C-ADR patients were divided into 3 groups based on final F/E ROM, those with 0° to 3° (n = 19), 4° to 6° (n = 15), and 7° (n = 42) of segmental motion at the index procedure level, the rate of progressive R-ALD trended significantly with final ROM (P = 0.01). CONCLUSIONS: C-ADR leads to a significant decrease in R-ALD compared to ACDF. The difference in R-ALD is related to the preservation of motion at the index level and resultant preservation of kinematics and forces across the adjacent disc space.

Enhanced Recovery After Surgery Trends in Adult Spine Surgery: A Systematic Review.

BACKGROUND: Enhanced Recovery After Surgery (ERAS) is a multimodal, multidisciplinary approach to optimizing the postsurgical recovery process through preoperative, perioperative, and postoperative interventions. ERAS protocols are emerging quickly within orthopedic spine surgery, yet there is a lack of consensus on optimal ERAS practices. OBJECTIVE: The aim of this systematic review is to identify and discuss the trends in spine ERAS protocols and the associated outcomes. METHODS: A literature search on PubMed was conducted to identify clinical studies that implemented ERAS protocols for various spine procedures in the adult population. The search included English-language literature published through December 2019. Additional sources were retrieved from the reference lists of key studies. Studies that met inclusion criteria were identified manually. Data regarding the study population, study design, spine procedures, ERAS interventions, and associated outcome metrics were extracted from each study that met inclusion criteria. RESULTS: Of the 106 studies identified from the literature search, 22 studies met inclusion criteria. From the ERAS protocols in these studies, common preoperative elements include patient education and modified preoperative nutrition regimens. Perioperative elements include multimodal analgesia and minimally invasive surgery. Postoperative elements include multimodal pain management and early mobilization/rehabilitation/nutrition regimens. Outcomes from ERAS implementation include significant reductions in length of stay, cost, and opioid consumption. Although these trends were observed, there remained great variability among the ERAS protocols, as well as in the reported outcomes. CONCLUSIONS: ERAS may improve cost-effectiveness to varying degrees for spinal procedures. Specifically, the use of multimodal analgesia may reduce overall opioid consumption. However, the benefits of ERAS likely will vary based on the specific procedure. CLINICAL RELEVANCE: This review contributes to the assessment of ERAS protocol implementation in the field of adult spine surgery.

The effect of vascular approach surgeons on perioperative complications in lateral transpsoas lumbar interbody fusions.

BACKGROUND CONTEXT: Lateral lumbar interbody fusion (LLIF) is a popular technique used in spine surgery. It is minimally invasive, provides indirect decompression, and allows for coronal plane deformity correction. Despite these benefits, the approach to LLIF has been linked to complications associated with the lumbosacral plexus and vascular anatomy. As a result, vascular surgeons may be recruited for the exposure portion of the procedure. PURPOSE: The purpose of this study was to compare exposure-related complication and postoperative (postop) neuropraxia rates between exposure (EXP) and spine surgeon only (SSO) groups while performing the approach for LLIF. STUDY DESIGN/SETTING: Retrospective analysis of patients treated at a single institution. PATIENT SAMPLE: Patients undergoing LLIF procedures between 2012 and 2018. OUTCOME MEASURES: Operative time, estimated blood loss, fluoroscopy, length of stay (LOS), intra- and postoperative complications, and physiologic measures including pre- and postoperative motor examinations and unresolved neuropraxia. METHODS: Patients who underwent LLIF were separated into EXP and SSO groups based on the presence or absence of vascular/general surgeon during the approach. The entire clinical history of patients with a decrease in pre- and postop motor examination was reviewed for the presence of neuropraxia. All other intra- and postop exposure-related complications were recorded for comparison. Propensity score matching (PSM) was performed to account for age, Charlson Comorbidity Index (CCI) percentage of LLIFs including L4-L5, and number of levels fused. Independent t test and chi-square analyses were used to identify significant differences between EXP and SSO groups. Statistical significance was set at p<.05. RESULTS: Two hundred and seventy-five patients underwent LLIF procedures, 155 SSO and 120 EXP. Postoperatively, 26 patients (11.1%) experienced a drop in any Medical Research Council (MRC) score, and two patients (0.7%) experienced unresolved quadriceps palsies. The mean recovery time for MRC scores was 84.4 days. Other complications included 2 pneumothoraces (0.7%), 1 iliac vein injury (0.4%), 14 cases of ileus (5.1%), 3 pulmonary emboli (1.1%), 2 deep vein thrombosis (0.7%), 3 cases of abdominal wall paresis (1.1%), and one abdominal hematoma (0.4%). After PSM, demographics including age, gender, body mass index, CCI, levels fused, and operative time were similar between cohorts. Twenty patients had changes in pre- to postop motor scores (SSO 9.4%, EXP 12.4%, p>.05). Iliopsoas motor scores decreased at the highest rate (EXP 12.4%, SSO 8.2%, p>.05) followed by quadriceps (EXP 5.2%, SSO 4.7%, p>.05). One SSO patient's postop course was complicated by a foot drop but returned to baseline within 1 year. One patient in EXP group developed an unresolved quadriceps palsy (EXP 1.0%, SSO 0.0%, p>.05). Intraoperative exposure complications included one pneumothorax (EXP 1.0%, SSO 0.0%, p>.05). There were no differences in PE/DVT, Ileus, or LOS. In the EXP cohort, three patients experienced abdominal wall paresis (EXP 2.9%, SSO 0.00%, p=.246). CONCLUSIONS: Comparing the LLIF exposures performed by EXP and SSO, we found no significant difference in the rates of complications. Additional research is needed to determine the etiology of the abdominal wall complications. In conclusion, neuropraxia- and approach-related complications are similarly low between exposure and spine surgeons.

Three-dimensional printing in spine surgery: a review of current applications.

In recent years, the use of three-dimensional printing (3DP) technology has gained traction in orthopedic spine surgery. Although research on this topic is still primarily limited to case reports and small cohort studies, it is evident that there are many avenues for 3DP innovation in the field. This review article aims to discuss the current and emerging 3DP applications in spine surgery, as well as the challenges of 3DP production and limitations in its use. 3DP models have been presented as helpful tools for patient education, medical training, and presurgical planning. Intraoperatively, 3DP devices may serve as patient-specific surgical guides and implants that improve surgical outcomes. However, the time, cost, and learning curve associated with constructing a 3DP model are major barriers to widespread use in spine surgery. Considering the costs and benefits of 3DP along with the varying risks associated with different spine procedures, 3DP technology is likely most valuable for complex or atypical spine disorder cases. Further research is warranted to gain a better understanding of how 3DP can and will impact spine surgery.

Five-Year Reoperation Rates of 2-Level Lumbar Total Disk Replacement Versus Fusion: Results of a Prospective, Randomized Clinical Trial.

STUDY DESIGN: Long-term analysis of prospective randomized clinical trial data. SUMMARY OF BACKGROUND DATA: Lumbar total disk replacement (TDR) has been found to have equivalent or superior clinical outcomes compared with fusion and decreased radiographic incidence of adjacent level degeneration in single-level cases. OBJECTIVE: The purpose of this particular analysis was to determine the incidence and risk factors for secondary surgery in patients treated with TDR or circumferential fusion at 2 contiguous levels of the lumbar spine. METHODS: A total of 229 patients were treated and randomized to receive either TDR or circumferential fusion to treat degenerative disk disease at 2 contiguous levels between L3 and S1 (TDR, n=161; fusion, n=68). RESULTS: Overall, at final 5-year follow-up, 9.6% of subjects underwent a secondary surgery in this study. The overall rate of adjacent segment disease was 3.5% (8/229). At 5 years, the percentage of subjects undergoing secondary surgeries was significantly lower in the TDR group versus fusion (5.6% vs. 19.1%, P=0.0027).Most secondary surgeries (65%, 17/26) occurred at the index levels. Index level secondary surgeries were most common in the fusion cohort (16.2%, 11/68 subjects) versus TDR (3.1%, 5/161 subjects, P=0.0009). There no statistically significant difference in the adjacent level reoperation rate between TDR (2.5%, 4/161) and fusion (5.9%, 4/68). The most common reason for index levels reoperation was instrumentation removal (n=9). Excluding the instrumentation removals, there was not a significant difference between the treatments in index level reoperations or in reoperations overall. CONCLUSIONS: There were significantly fewer reoperations in TDR patients compared with fusion patients. However, most of the secondary surgeries were instrumentation removal in the fusion cohort. Discounting the instrumentation removals, there was no significant difference in reoperations between TDR and fusion. These results are indicative that lumbar TDR is noninferior to fusion.

The Effect of Smoking on Spinal Fusion.

BACKGROUND: Spinal fusion surgery is performed about half a million times per year in the United States and millions more worldwide. It is an effective method for reducing pain, increasing stability, and correcting deformity in patients with various spinal conditions. In addition to being a well-established risk factor for a variety of medical conditions, smoking has deleterious effects on the bone healing of spinal fusions. This review aims to specifically analyze the ways in which smoking affects the outcomes of spinal fusion and to explore ways in which these negative consequences can be avoided. PURPOSE: This article provides a complete understanding of the ways smoking affects spinal fusion from a biochemical and clinical perspective. Recommendations are also provided for ways in which surgeons can limit patient exposure to the most serious negative outcomes associated with cigarette smoking. STUDY DESIGN/SETTING: This study was a retrospective literature review done using the NCBI database. The research was compiled at NYU Hospital for Joint Diseases and the NYU Center for Musculoskeletal Care. METHODS: A comprehensive literature review was done spanning research on a variety of subjects related to smoking and spinal fusion surgery. The biochemistry of smoking and fusion healing were examined in great detail. In addition, both in vivo animal studies and human clinical studies were evaluated to explore fusion success related to the effects of smoking and its biochemical factors on spinal fusion surgery. RESULTS: Smoking significantly increases the risk of pseudoarthrosis for patients undergoing both lumbar and cervical fusions. In addition to nonunion, smoking also increases the risk of other perioperative complications such as infection, adjacent-segment pathology, and dysphagia. Treatment options are available that can be explored to reduce the risk of smoking-related morbidity, such as nicotine replacement therapy and use of bone morphogenetic proteins (BMPs). CONCLUSIONS: It has been clearly demonstrated from both a biochemical and clinical perspective that smoking increases the rate of perioperative complications for patients undergoing spinal fusion surgery, particularly pseudoarthosis. It has also been shown that there are certain approaches that can reduce the risk of morbidity. The most important recommendation is smoking cessation for four weeks after surgery. In addition, patients may be treated with certain surgical techniques, including the use of BMPs, to reduce the risk of pseudoarthrosis. Lastly, nicotine replacement therapy is an area of continued interest in relation to spinal fusion outcomes and more research needs to be done to determine its efficacy moving forward.

Cost-Effectiveness of Lumbar Spondylolisthesis Surgery at 2-Year Follow-up.

OBJECTIVES: The purpose of this study was to determine the cost/quality-adjusted life-year (QALY) of the operative treatment of lumbar spondylolisthesis and identify factors associated with cost-effectiveness at 2 years. METHODS: We evaluated patients who underwent surgery for spondylolisthesis. The QALY was determined from the EQ5D. Outcomes were also assessed using the Oswestry Disability Index (ODI). Surgical, neuromonitoring, and anesthesia Current Procedural Terminology (CPT) codes as well as hospital Diagnosis-Related Group codes were used to determine the Medicare direct care costs of surgery. Indirect costs were modeled based on existing literature. A discounting rate of 3% was applied. Analysis was performed to determine which factors were associated with a cost/QALY less than $100,000. RESULTS: There were 44 patients who underwent surgery for either degenerative (30) or isthmic spondylolisthesis (14). There were 27 women and 17 men, with an average age at surgery of 59.7 years (standard deviation [SD] = 14.69) and an average follow-up of 2 years (SD = 0.82). The average postoperative improvement in ODI was 24.77 (SD = 23.9), and change in QALY was 0.43 (SD = 0.30). The average cost/QALY at 2 years for direct care costs was $89,065. The average cost/QALY at 2 years for direct plus indirect costs was $112,588. Higher preoperative leg pain and greater leg pain change was associated with a cost/QALY <$100,000 (p < .005, p < .028). The cost-effective group had a higher proportion of patients with disease extent of two or more levels (p = .021). When comparing surgical techniques of anterior-posterior and posterior only, there was no difference in cost-effectiveness. CONCLUSIONS: Spondylolisthesis surgery is cost-effective at 2 years, with a QALY change of 0.43 and a direct cost/QALY of $89,065. Higher preoperative leg pain and larger extent of disease was associated with cost-effectiveness. LEVEL OF EVIDENCE: IV.

Analysis of Postoperative Thoracolumbar Spine Infections in a Prospective Randomized Controlled Trial Using the Centers for Disease Control Surgical Site Infection Criteria.

INTRODUCTION: Wound infections following spinal surgery place a high toll on both the patient and the healthcare system. Although several large series studies have examined the incidence and distribution of spinal wound infection, the applicability of these studies varies greatly since nearly every study is either retrospective and/or lacks standard inclusion criteria for defining surgical site infection. To address this void, we present results from prospectively gathered thoracolumbar spine surgery data for which the Centers for Disease Control (CDC) criteria were stringently applied to define a surgical site infection (SSI). METHODS: A prospective randomized trial of 314 patients who underwent multilevel thoracolumbar spinal surgery with instrumentation followed by postoperative drain placement was completed (Takemoto et al., 2015). The trial consisted of two antibiotic arms: one for 24-hours, and the other for the duration of the drain; no differences were found between the arms. All infections meeting CDC criteria for SSI were included. RESULTS: A total of 40 infections met CDC criteria for SSI, for an overall incidence of 12.7%. Of these, 20 (50%) were culture-positive. The most common organism was Staphylococcus aureus (4 total: methicillin-sensitive=2; methicillin-resistant=2), followed by coagulase-negative Staphylococcus (3 cases), Propionibacterium acnes and Escherichia coli (2 cases each). Six infections grew multiple organisms, most commonly involving coagulase-negative staphylococcus and enterococcus. CONCLUSIONS: Our findings indicate that thoracolumbar SSI occurs at the higher end of the range cited in the literature (2-13%), which is largely based on retrospective data not subjected to the inclusivity of SSI as defined by the CDC. The three most common organisms in our analysis (S. aureus, P. acnes, E. coli) are consistent with previous reports. Staphylococcus aureus continues to be the most common causative organism and continued vigilance and searching for preventive measures need to be a high priority. This study provides Level I evidence.

ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease: Seven-Year Follow-up of the Prospective Randomized U.S. Food and Drug Administration Investigational Device Exemption Study.

BACKGROUND: In patients with single-level cervical degenerative disc disease, total disc arthroplasty can relieve radicular pain and preserve functional motion between two vertebrae. We compared the efficacy and safety of cervical total disc arthroplasty with that of anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical degenerative disc disease between C3-C4 and C6-C7. METHODS: Two hundred and nine patients at thirteen sites were randomly treated with either total disc arthroplasty with ProDisc-C (n = 103) or with ACDF (n = 106). Patients were assessed preoperatively; at six weeks and three, six, twelve, eighteen, and twenty-four months postoperatively; and then annually until seven years postoperatively. Outcome measures included the Neck Disability Index (NDI), the Short Form-36 (SF-36), postoperative neurologic parameters, secondary surgical procedures, adverse events, neck and arm pain, and satisfaction scores. RESULTS: At seven years, the overall follow-up rate was 92% (152 of 165). There were no significant differences in demographic factors, follow-up rate, or patient-reported outcomes between groups. Both procedures were effective in reducing neck and arm pain and improving and maintaining function and health-related quality of life. Neurologic status was improved or maintained in 88% and 89% of the patients in the ProDisc-C and ACDF groups, respectively. After seven years of follow-up, thirty secondary surgical procedures had been performed in nineteen (18%) of 106 patients in the ACDF group compared with seven secondary surgical procedures in seven (7%) of 103 patients in the ProDisc-C group (p = 0.0099). There were no significant differences in the rates of any device-related adverse events between the groups. CONCLUSIONS: Total disc arthroplasty with ProDisc-C is a safe and effective surgical treatment of single-level symptomatic cervical degenerative disc disease. Clinical outcomes after total disc arthroplasty with ProDisc-C were similar to those after ACDF. Patients treated with ProDisc-C had a lower probability of subsequent surgery, suggesting that total disc arthroplasty provides durable results and has the potential to slow the rate of adjacent-level disease. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Association between compensation status and outcomes in spine surgery: a meta-analysis of 31 studies.

BACKGROUND CONTEXT: Numerous studies have demonstrated poorer outcomes in patients with Workers' compensation (WC) when compared with those without WC following treatment of various of health conditions, including spine disorders. It is thus important to consider compensation status when assessing treatment outcomes in spine surgery. However, reported strengths of association have varied significantly (1.31-7.22). PURPOSE: The objective of this study was to evaluate the association of unsatisfactory outcomes on compensation status in spine surgery patients. STUDY DESIGN/SETTING: A meta-analysis was performed. PATIENT SAMPLE: Patient sample is not applicable in this study. OUTCOME MEASURE: Demographics, type of surgery, country, follow-up time, patient satisfaction, return to work and non-union events were the outcome measures. METHODS: Both prospective and retrospective studies that compared outcomes between compensated and non-compensated patients in spine surgery were included. Two independent investigators extracted outcome data. The meta-analysis was performed using Revman software. Random effects model was used to calculate risk ratio (RR, 95% confidence interval [CI]) for dichotomous variables. RESULTS: Thirty-one studies (13 prospective; 18 retrospective) with a total of 3,567 patients were included in the analysis. Follow-up time varied from 4 months to 10 years. Twelve studies involved only decompression; the rest were fusion. Overall RR of an unsatisfactory outcome was 2.12 [1.74, 2.58; p<.001] in patients with WC when compared with those without WC after surgery. The RR of an unsatisfactory outcome in patients with WC, compared with those without, was 2.09 [1.38, 3.17]; p<.01 among studies from Europe and Australia, and 2.14 [1.48, 2.60]; p<.01 among US studies. The RR of decompression-only procedures was 2.53 [1.85, 3.47]; p<.01,and 1.79 [1.45, 2.21]; p<.01 for fusion. Forty-three percent (209 of 491) of patients with WC did not return to work versus 17% (214 of 1250) of those without WC (RR 2.07 [1.43, 2.98]; p<.001). Twenty-five percent (74 of 292) and 13.5% (39 of 287) of patients had non-union in the compensated and non-compensated groups, respectively. This was not statistically significant (RR 1.33 [0.92, 1.91]; p=.07). CONCLUSIONS: Workers' compensation patients have a two-fold increased risk of an unsatisfactory outcome compared with non-compensated patients after surgery. This association was consistent when studies were grouped by country or procedure. Compensation status must be considered in all surgical intervention studies.

A Review of Symptomatic Lumbosacral Transitional Vertebrae: Bertolotti's Syndrome.

BACKGROUND: Lumbosacral transitional vertebrae (LSTV) are increasingly recognized as a common anatomical variant associated with altered patterns of degenerative spine changes. This review will focus on the clinical significance of LSTV, disruptions in normal spine biomechanics, imaging techniques, diagnosis, and treatment. METHODS: A Pubmed search using the specific key words "LSTV," "lumbosacral transitional vertebrae," and "Bertolotti's Syndrome" was performed. The resulting group of manuscripts from our search was evaluated. RESULTS: LSTV are associated with alterations in biomechanics and anatomy of spinal and paraspinal structures, which have important implications on surgical approaches and techniques. LSTV are often inaccurately detected and classified on standard AP radiographs and MRI. The use of whole-spine images as well as geometric relationships between the sacrum and lumbar vertebra increase accuracy. Uncertainty regarding the cause, clinical significance, and treatment of LSTV persists. Some authors suggest an association between LSTV types II and IV and low back pain. Pseudoarticulation between the transverse process and the sacrum creates a "false joint" susceptible to arthritic changes and osteophyte formation potentially leading to nerve root entrapment. The diagnosis of symptomatic LSTV is considered with appropriate patient history, imaging studies, and diagnostic injections. A positive radionuclide study along with a positive effect from a local injection helps distinguish the transitional vertebra as a significant pain source. Surgical resection is reserved for a subgroup of LSTV patients who fail conservative treatment and whose pain is definitively attributed to the anomalous pseudoarticulation. CONCLUSIONS: Due to the common finding of low back pain and the wide prevalence of LSTV in the general population, it is essential to differentiate between symptoms originating from an anomalous psuedoarticulation from other potential sources of low back pain. Further studies with larger sample sizes and longer follow-up time would better demonstrate the effectiveness of surgical resection and help guide treatment.

Appropriateness of Twenty-four-Hour Antibiotic Prophylaxis After Spinal Surgery in Which a Drain Is Utilized: A Prospective Randomized Study.

BACKGROUND: Wound drains that are left in place for a prolonged period of time have a higher rate of bacterial contamination. Following spinal surgery, a drain is often left in place for a longer period of time if it maintains a high output. Given the major consequences of an infection following spinal surgery and the lack of data with regard to the use of antibiotics and drains, we performed a study of patients with a drain following spinal surgery to compare infection rates between those who were treated with antibiotics for twenty-four hours and those who received antibiotics for the duration for which the drain was in place. METHODS: We performed a prospective randomized trial of 314 patients who underwent multilevel thoracolumbar spinal surgery followed by use of a postoperative drain. The patients were randomized into two groups, one of which received perioperative antibiotics for twenty-four hours (twenty-four-hour group) and the other of which received antibiotics for the duration that the drain was in place (drain-duration group). Data collected included demographic characteristics, medical comorbidities, type of spinal surgery, and surgical site infection. RESULTS: Twenty-one (12.4%) of the 170 patients in the twenty-four-hour group and nineteen (13.2%) of the 144 in the drain-duration group developed a surgical site infection (p = 0.48). There were no significant differences between the twenty-four-hour and drain-duration groups with respect to demographic characteristics (except for the American Society of Anesthesiologists [ASA] classification), operative time, type of surgery, drain output, or length of hospital stay. CONCLUSIONS: Continuing perioperative administration of antibiotics for the entire duration that a drain is in place after spinal surgery did not decrease the rate of surgical site infections.

Systematic Review of Thigh Symptoms after Lateral Transpsoas Interbody Fusion for Adult Patients with Degenerative Lumbar Spine Disease.

BACKGROUND: Lateral transpsoas interbody fusion (LTIF) is a minimally invasive technique for achieving lumbar spinal fusion. While it has many advantages over open techniques it carries with it a distinct set of risks, most commonly post-operative ipsilateral thigh pain, weakness and sensory disturbances. It is vital for both the surgeon and patient to understand the risks for and outcomes of injury associated with this procedure. We conducted a systematic review of the literature to evaluate the incidence, risks, and long-term clinical outcomes of post-operative thigh symptoms in patients treated with LTIF. METHODS: We conducted a search of MEDLINE, EMBASE, CINAHL, Scopus, Web of Science and the Cochrane Collaboration Library, using keywords and MeSH terms, for English-language literature published through September 2014, as well as reference lists from key articles. Studies were then manually filtered to retrieve articles that met inclusion criteria. We were interested in studies that reported postoperative lower extremity symptoms after LTIF, such as pain, weakness and changes in sensation. The strength of evidence was determined based on precepts outlined by the Grades of Recommendation Assessment, Development and Evaluation Working Group (GRADE). RESULTS: A total of 392 articles were initially retrieved, with 24 ultimately meeting criteria for inclusion. The incidence of any post-operative thigh symptom varied, ranging as high as 60.7%, with 9.3% of patients experiencing a motor deficit related to direct nerve injury. Several studies reported cases of persistent symptoms at 6 months follow up. Additionally, inclusion of the L4-5 disc space and a longer duration of surgery were both identified as risks for developing postoperative thigh symptoms. CONCLUSION: The risk of postoperative thigh symptoms after LTIF is high. Thigh pain, paresthesias and weakness were the most commonly reported symptoms. While most patients' symptoms resolved by 6 months follow up, several studies reported patients with symptoms persistent as far as 12 months removed from surgery. Surgery at the L4-5 disc space and longer surgical duration place the patient at greater risk for developing postoperative and long-term thigh symptoms.

Outcomes and complications of the midline anterior approach 3 years after lumbar spine surgery.

Objective. The purpose of this study was to evaluate a new questionnaire to assess outcomes related to the midline anterior lumbar approach and to identify risk factors for negative patient responses. Methods. A retrospective review of 58 patients who underwent anterior lumbar surgery at a single institution for either degenerative disc disease or spondylolisthesis in 2009 was performed. The outcome measures included our newly developed Anterior Lumbar Surgery Questionnaire (ALSQ), ODI, and EQ-5D. Results. There were 58 patients available for followup, 27 women and 31 men. The average age at surgery was 50.8 years, with an average followup of 2.92 years. The average change in ODI was 34.94 (22.7) and EQ-5D was 0.28 (0.29). The rate of complications with the anterior approach was 10.3% and there was one male patient (3.2%) with retrograde ejaculation. Determination of the effectiveness of the new ALSQ revealed that it significantly correlated to the EQ-5D and ODI (P < 0.05). Smoking was associated with a negative response on thirteen questions. BMP use was not associated with a negative response on any sexual function questions. Conclusions. Our new Anterior Lumbar Surgery Questionnaire determines patient perceived complications related to the midline anterior lumbar surgical approach.

ProDisc-C and anterior cervical discectomy and fusion as surgical treatment for single-level cervical symptomatic degenerative disc disease: five-year results of a Food and Drug Administration study.

STUDY DESIGN: Randomized controlled trial. OBJECTIVE: Analyze the clinical outcomes at 5 years comparing cervical total disc replacement (TDR) with ProDisc-C (Synthes Spine USA Products; LLC, West Chester, PA) with anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA: Previous reports of 2- and 4-year results have shown that ProDisc-C, a TDR for surgical treatment of patients experiencing single-level symptomatic cervical disc disease between C3 and C7, is safe and effective. METHODS: Two hundred nine patients (103 ProDisc-C and 106 ACDF) from 13 sites were randomized and treated. Results including neck disability index, visual analog scale (VAS) neck and arm pain, Short Form-36 (SF-36), neurological examination, device success, adverse event occurrence, and VAS patient satisfaction were analyzed. RESULTS: Demographics were similar between the 2 patient groups (ProDisc-C: 42.1 ± 8.4 yr, 44.7% males; ACDF: 43.5 ± 7.1 yr, 46.2% males). Rates of follow-up at 2 years were 98.1% ProDisc-C and 94.8% ACDF, and at 5 years 72.7% ProDisc-C and 63.5% ACDF. For all clinical outcomes for both groups, there was a statistically and clinically significant improvement at 2 and 5 years compared with baseline. At 5 years, ProDisc-C patients had statistically significantly less neck pain intensity and frequency. Both groups scored high VAS satisfaction scores at 5 years, with ProDisc-C 86.56 and ACDF 82.74. There were no reports of device failures or implant migration with ProDisc-C. The ProDisc-C patients maintained motion at their index level. At 5 years, the ProDisc-C patients had a statistically significantly lower rate of reoperation compared with ACDF patients (2.9% vs. 11.3%). CONCLUSION: Five-year results show that TDR with ProDisc-C is a safe and effective treatment of single-level symptomatic cervical disc disease. Clinical outcomes were comparable with ACDF. ProDisc-C patients maintained motion at the index level and had significantly less neck pain intensity and frequency as well as a lower probability of secondary surgery.

Hospital for joint diseases participates in international spine registry Spine Tango after successful pilot study.

Spine Tango is currently the only international spine registry in existence. It was developed under the auspices of Eurospine, the Spine Society of Europe, and is hosted at the University of Bern, Switzerland. The HJD Spine Center successfully tested Spine Tango during a 3-month pilot study and has since expanded documentation activities to more surgeons. Workflow integration and dedicated research staff are key factors for such an endeavor. Participation enables benchmarking against national and international peers and outcome research and quality assurance of surgical and non-surgical treatments.

Outcomes analysis of anterior-posterior fusion for low grade isthmic spondylolisthesis.

BACKGROUND: Traditional surgical treatment of isthmic spondylolisthesis is posterior-lateral fusion, but the addition of anterior surgery has been explored. The purpose of this study was to evaluate the surgical and clinical outcomes of anterior-posterior surgical treatment for low-grade isthmic spondylolisthesis. METHODS: Retrospectively, we enrolled 23 consecutive patients (mean age of 50) who underwent surgical treatment for low grade isthmic spondylolisthesis. The mean follow-up was 10 months. Basic demographic and radiographic data was collected. Pre- and post-surgical clinical surveys (VAS, ODI, and SF-36) were collected. RESULTS: All 23 patients underwent anterior interbody fusion with a femoral ring allograft or ICBG in combination with posterior lumbar decompression and fusion with instrumentation. The average slip percentage decreased from 23.2% to 19.0% (p = 0.24) while slip angle increased from 9.8° to 17.9° (p < 0.001) and average disc height decreased from 1.9 cm to 0.80 cm (p < 0.001). VAS scores decreased from 7.1 to 2.4 (p < 0.001), ODI scores decreased from 52.5 to 28.1 (p < 0.001), and SF-36 scores increased in the Physical Component Scale (PCS) from 29.5 to 42.6 (p < 0.001). CONCLUSION: In our study, patients demonstrated an improvement in the ODI as well the physical component scores of the SF-36, thus having a good clinical outcome.

The Incidence of Potential Candidates for Total Disc Replacement among Lumbar and Cervical Fusion Patient Populations.

STUDY DESIGN: Retrospective chart review. PURPOSE: To evaluate the incidence of potential total disc replacement (TDR) candidates among cervical and lumbar fusion patient populations using strict Food and Drug Administration (FDA) criteria and with relative exclusion criteria removed. OVERVIEW OF LITERATURE: Recent studies suggest that the potential percentage of patients that are candidates for TDR ranges from 0-5% in lumbar fusions and 43% in cervical fusions. METHODS: We performed a retrospective chart review of 280 consecutive patients who had lumbar (n = 174) and cervical (n = 106) fusion or TDR performed by one of four independent adult orthopaedic spine surgeons. Charts were screened for investigational device exemption (IDE) inclusion/exclusion criteria and later reanalyzed excluding relative exclusion criteria, such as history of chronic medical illness, twolevel disease (cervical cases), and history of prior fusion surgery in the anatomic region. RESULTS: Of the 174 lumbar surgeries, 10 were TDR with Prodisc-L and 164 were lumbar fusions. The most common TDR exclusion criteria were lytic spondylolisthesis or spinal stenosis (47.7% of patients) and more than 2 level degenerative disc disease (37.9%). 14.9% had no IDE exclusion criteria and would be considered candidates for TDR. After excluding the relative lumbar exclusion criteria, this percentage increased to 25.8%. Of the 106 cervical cases, 3 had a TDR with Prodisc-C and 103 had a cervical fusion. Twenty eight percent had no IDE exclusion criteria and would be considered candidates for cervical TDR. CONCLUSIONS: A larger percentage of cervical fusion candidates are potential candidates for TDR (28%) than lumbar fusion candidates (14.9%) based on the strict IDE criteria.

The prevalence of transitional vertebrae in the lumbar spine.

BACKGROUND CONTEXT: Lumbosacral transitional vertebrae (LSTVs) are a congenital vertebral anomaly of the L5-S1 junction in the spine. This alteration may contribute to incorrect identification of a vertebral segment, leading to wrong-level spine surgery and poor correlation with clinical symptoms. Although several studies describe the occurrence of this anomaly in back pain populations, investigation of the prevalence in the American general population is lacking. PURPOSE: To establish the prevalence rates for LSTVs in the general population. STUDY DESIGN: Retrospective review. PATIENT SAMPLE: Consecutive kidney-urinary bladder (KUB) radiographs of subjects from the past 2 years (2008-2009). OUTCOME MEASURES: Clinical demographics, number of lumbar vertebrae, L5-S1 transverse process (TP) height, and rib length. METHODS: Consecutive adult KUB studies of adult subjects were queried with clear visibility of the last rib's vertebral body articulation, all lumbar TPs, and complete sacral wings. Exclusion criteria consisted of any radiologic evidence of previous lumbosacral surgery that would obstruct our measurements. A total of 1,100 abdominal films were reviewed, and 211 were identified as being adequate for the measurement of the desired parameters. RESULTS: Two hundred eleven subjects were identified as eligible for the study, and 75 (35.6%) were classified as positive for a transitional lumbosacral vertebra. The most common anatomical variant was the Castellvi Type IA (14.7%). The average age at the time of the KUB study was 59.8 years (18-95 years). One hundred ninety-seven subjects (93.4%) presented five lumbar (nonribbed) vertebrae, and only 14 (6.6%) had six lumbar vertebrae. CONCLUSIONS: The significance of lumbosacral transitional level changes to the establishment of pain, degenerative changes, stenosis, and disc disease have been well documented in symptomatic patients. Although LSTV's role in low back pain remains controversial, our study has shown that, when the same criteria are used for classification, prevalence among the general population and symptomatic patients may be similar.

Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of the ProDisc-L total disc replacement compared with circumferential arthrodesis for the treatment of two-level lumbar degenerative disc disease: results at twenty-four months.

BACKGROUND: Disc replacement arthroplasty previously has been shown to be an effective alternative to spine fusion for the treatment of single-level lumbar degenerative disc disease. The purpose of the present study was to determine the twenty-four-month results of a clinical trial of the ProDisc-L total disc replacement as compared with spinal fusion for the treatment of degenerative disc disease at two contiguous vertebral levels from L3 to S1. METHODS: A total of 237 patients were treated in a randomized controlled trial designed as a non-inferiority study for regulatory application purposes. Blocked randomization was performed with use of a 2:1 ratio of total disc arthroplasty to circumferential arthrodesis. Evaluations, including patient self-assessments, physical and neurological examinations, and radiographic examinations, were performed preoperatively, six weeks postoperatively, and three, six, twelve, eighteen, and twenty-four months postoperatively. RESULTS: At twenty-four months, 58.8% (eighty-seven) of 148 patients in the total disc replacement group were classified as a statistical success, compared with 47.8% (thirty-two) of sixty-seven patients in the arthrodesis group; non-inferiority was demonstrated. The mean Oswestry Disability Index in both groups significantly improved from baseline (p < 0.0001); the mean percentage improvement for the total disc replacement group was significantly better than that for the arthrodesis group (p = 0.0282). An established clinical criterion for success, a ≥15-point improvement in the Oswestry Disability Index from baseline, occurred in 73.2% (109) of 149 patients in the total disc replacement group and 59.7% (thirty-seven) of sixty-two patients in the arthrodesis group. The Short Form-36 physical component scores were significantly better for the total disc replacement group as compared with the arthrodesis group (p = 0.0141 at twenty-four months). Visual analog scale scores for satisfaction significantly favored total disc replacement from three to twenty-four months. At twenty-four months, 78.2% (111) of 142 patients in the total disc replacement group and 62.1% (thirty-six) of fifty-eight patients in the arthrodesis group responded "yes" when asked if they would have the same surgery again. Lumbar spine range of motion on radiographs averaged 7.8° at the superior disc and 6.2° at the inferior disc in patients with total disc replacement. Reduction in narcotics usage significantly favored the total disc replacement group at twenty-four months after surgery (p = 0.0020). CONCLUSIONS: Despite the relatively short duration of follow-up and design limitations, the present study suggests that two-level lumbar disc arthroplasty is an alternative to and offers clinical advantages in terms of pain relief and functional recovery in comparison with arthrodesis. Longer-term follow-up is needed to determine the risks for implant wear and/or degenerative segment changes.