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Analysis of Postoperative Thoracolumbar Spine Infections in a Prospective Randomized Controlled Trial Using the Centers for Disease Control Surgical Site Infection Criteria
McClelland, Shearwood 3rd; Takemoto, Richelle C; Lonner, Baron S; Andres, Tate M; Park, Justin J; Ricart-Hoffiz, Pedro A; Bendo, John A; Goldstein, Jeffrey A; Spivak, Jeffrey M; Errico, Thomas J
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.
PMCID:4943169
PMID: 27441172
ISSN: 2211-4599
CID: 2185062
Cervical disc replacement - emerging equivalency to anterior cervical discectomy and fusion
Buckland, Aaron J; Baker, Joseph F; Roach, Ryan P; Spivak, Jeffrey M
PURPOSE: Cervical disc replacement has become an acceptable alternative to anterior cervical fusion for the surgical treatment of cervical spine spondylosis resulting in radiculopathy or myelopathy following anterior discectomy and decompression. This concise overview considers the current state of knowledge regarding the continued debate of the role of cervical disc replacement with an update in light of the latest clinical trial results. METHODS: A literature review was performed identifying clinical trials pertaining to the use of cervical disc replacement compared to cervical discectomy and fusion. Single level disease and two level disease were considered. Outcome data from the major clinical trials was reviewed and salient points identified. RESULTS: With lengthier follow-up data becoming available, the equivalence of CDR in appropriately selected cases is becoming clear. This is chiefly manifested by reduced re-operation rates and reduced incidence of adjacent level disease in those treated with arthroplasty. CONCLUSION: Cervical disc replacement shows emerging equivalence in outcomes compared to the gold standard anterior cervical discectomy and fusion. Further longer term results are anticipated to confirm this trend.
PMID: 27055447
ISSN: 1432-5195
CID: 2066212
"Reverse Bohlman" technique for the treatment of high grade spondylolisthesis in an adult population
Macagno, Angel E; Hasan, Saqib; Jalai, Cyrus M; Worley, Nancy; de Moura, Alexandre B; Spivak, Jeffrey; Bendo, John A; Passias, Peter G
BACKGROUND/AIMS: Surgical techniques for effective high-grade spondylolisthesis (HGS) remain controversial. This study aims to evaluate radiographic/clinical outcomes in HGS patients treated using modified "Reverse Bohlman" (RB) technique. METHODS: Review of consecutive HGS patients undergoing RB at a single university-center from 2006 to 2013. Clinical, surgical, radiographic parameters collected. RESULTS: Six patients identified: five with L5-S1 HGS with L4-L5 instability and one had an L4-5 isthmic spondylolisthesis and grade 1 L5-S1 isthmic spondylolisthesis. Two interbody graft failures and one L5-S1 pseudoarthrosis. Postoperative improvement of anterolisthesis (62.3% vs. 49.6%, p = 0.003), slip angle (10 vs. 5 degrees , p = 0.005), and lumbar lordosis (49 vs. 57.5 degrees , p = 0.049). CONCLUSIONS: RB technique for HGS recommended when addressing adjacent level instability/slip.
PMCID:4761627
PMID: 26955227
ISSN: 0972-978x
CID: 2023502
Surgical management of lumbar degenerative spondylolistheis
Chapter by: Husain, Qasim M; Norton, Robert P; Spivak, Jeffrey M
in: Spinal disorders and treatments : the NYU-HJD comprehensive textbook by Errico, Thomas J; Cheriyan, Thomas; Varlotta, Gerard P [Eds]
New Delhi : Jaypee Brothers, 2015
pp. 286-293
ISBN: 9351524957
CID: 2709362
Systematic Review of Thigh Symptoms after Lateral Transpsoas Interbody Fusion for Adult Patients with Degenerative Lumbar Spine Disease
Gammal, Isaac D; Spivak, Jeffrey M; Bendo, John A
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.
PMCID:4710156
PMID: 26767154
ISSN: 2211-4599
CID: 1912712
Complications of unilateral versus bilateral instrumentation in transforaminal lumbar interbody fusion: A meta-analysis [Meeting Abstract]
Cheriyan, T; Lafage, V; Bendo, J A; Spivak, J M; Goldstein, J A; Errico, T J
BACKGROUND CONTEXT: In transforminal lumbar interbody fusion (TLIF), bilateral pedicle screw/rod fixation has been shown to increase fusion construct stability and decrease posterior instrumentation stress when compared to unilateral instrumentation. However, unilateral instrumentation is beneficial over bilateral instrumentation due to shorter operative time, less blood loss and reduced implant costs. It is important to note though that comparative studies between unilateral and bilateral instrumentation in TLIF have shown similar patient satisfaction outcomes, they are limited in their evaluation of complications due to small sample size of studies. PURPOSE: The purpose of this meta-analysis was to evaluate complications, and fusion rates between unilateral and bilateral instrumentation in TLIF. STUDY DESIGN/SETTING: Meta-analysis of randomized controlled trials. PATIENT SAMPLE: 549 patients undergoing one- and multi-levels TLIF. OUTCOME MEASURES: Outcome data extracted included fusion rates, health related quality of life (HRQoL) scores and complications including cage migration, dural tear, deep vein thrombosis, surgical site infections and screw failures. METHODS: Randomized controlled trials (RCTs) that compared outcomes between unilateral and bilateral pedicle screw instrumentation in single- and multi-level TLIF were identified. Data extraction was performed by two independent reviewers. Meta-analysis was performed using RevMan 5. Weighted standardized mean difference (SMD) and odds ratio (OR) 95% confidence intervals (CI) were calculated. Jadad scoring was used to assess bias of included studies. RESULTS: Eight RCTs were included, having a total of 549 patients (267 unilateral/282 bilateral). Minimum follow-up ranged from 3 to 24 months. Bias-assessment scores varied between 0 and 3 indicating high-moderate bias-risk. Six involved open TLIF procedures and two involved minimally invasive TLIF. There was no difference between postoperative Health Related Quality of Life scores in the unilateral and bilateral instrumented groups (SMD = 0.29; [-0.77, 0.18]; p=0.69). There was no statistical difference in fusion rates (OR = 0.47; 95% CI [0.21, 1.04], p=0.68), with 88.9% and 95.0% achieving fusion in the unilateral and bilateral groups, respectively. The unilateral cohort had a higher incidence of cage migration (5.6%) when compared to the bilateral cohort (2.5%), approaching statically significant (p=0.07). Other complications which included dural tears, deep vein thrombosis, surgical site infections and screw failures were comparable between the groups. CONCLUSIONS: Fusion rates and complications appear comparable in unilateral and bilateral instrumentation in TLIF. Though not statistically significant, there was higher incidence of cage migration in the unilateral cohort
EMBASE:72100398
ISSN: 1529-9430
CID: 1905332
Association between compensation and outcomes in spine surgery: A meta-analysis of 31 studies [Meeting Abstract]
Cheriyan, T; Harris, B; Cheriyan, J; Bendo, J A; Spivak, J M; Lafage, V; Goldstein, J A
BACKGROUND CONTEXT: Numerous studies have demonstrated poorer outcomes in patients receiving Workers' Compensation following treatment of various 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: Meta-analysis. PATIENT SAMPLE: 3567 patients undergoing spine surgery. OUTCOME MEASURES: Demographics, type of surgery, country, follow-up time, patient satisfaction, return to work and non-union events. METHODS: Both prospective and retrospective studies that compared outcomes between compensated and non-compensated patients in spine surgery were included. Outcome data extracted by two independent investigators. The meta-analysis was performed using Revman software. Depending on heterogeneity, a fixed or random effects model was used to calculate risk ratio (RR, 95% confidence interval [CI]) for dichotomous variables. RESULTS: 31 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<0.001] in compensated patients when compared to noncompensated patients after surgery. RR of an unsatisfactory outcome in compensated patients compared to noncompensated was 2.09 [1.38, 3.17]; p< 0.01 among studies from Europe and Australia and 2.14 [1.48, 2.60]; p< 0.01 among US studies. RR of decompression-only procedures was 2.53 [1.85, 3.47] and 1.79 [1.45, 2.21] for fusion. 52% (182/491) of compensated patients returned to work versus 82% (1034/1250) of non-compensated (RR 0.73 [0.59, 0.90]; p<0.001). 25 % (74/292) and 13.5% (39/ 287) of patients had nonunion in the compensated and noncompensated groups, respectively. This was not statistically significant (RR 1.33 [0.92, 1.91]; p=0.07). CONCLUSIONS: Workers' Compensation patients have a two-fold increased risk of an unsatisfactory outcome compared to noncompensated 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
EMBASE:72100351
ISSN: 1529-9430
CID: 1905352
The benefit of continued motion of a cervical artificial disc replacement on radiographic adjacent level degeneration at 7-year follow-up [Meeting Abstract]
Spivak, J M; Zigler, J E; Janssen, M E; Darden, II B V; Radcliff, K E
BACKGROUND CONTEXT: Development of symptomatic adjacent level degeneration (ALD) following anterior cervical discectomy and fusion (ACDF) remains a clinical concern. Cervical artificial disc replacement (C-ADR) maintains motion at the surgical level, and has been demonstrated to lower the incidence of developing radiographic ALD (R-ALD) than following ACDF. PURPOSE: To compare the rates of progressive R-ALD 7 years postsurgery in patients treated with ProDisc-C (DePuy Synthes Spine, Raynham, MA) C-ADR or ACDF for one-level symptomatic cervical disc disease, and to examine the effect of final flexion-extension range of motion (ROM) of the C-ADR with the progression of RALD. STUDY DESIGN/SETTING: A prospective randomized FDA approved IDE study was conducted at 13 sites to assess the safety and effectiveness of single-level C-ADR compared to ACDF. The study included annual patient follow-up through 7 years. PATIENT SAMPLE: 209 patients were randomized and treated (106 ACDF; 103 C-ADR). OUTCOME MEASURES: All radiographs were assessed by independent radiologists utilizing a qualitative assessment of disc degeneration at adjacent levels based on the Kellgren-Lawrence system (0-4 scale). Range of motion at the index and adjacent levels were measured. METHODS: Radiographic results are presented for patients at final 7-year follow-up using the last observation carried forward with a minimum 5- year follow up. Progression in R-ALD, and ROM at the C-ADR, at the latest follow-up was assessed. RESULTS: Final follow-up data was available for 156 patients (86 C-ADR, 70 ACDF). Basic demographics were similar between the two patient groups. The rate of progressive R-ALD at either adjacent level (worse case) was statistically significantly lower in the C-ADR cohort compared to ACDF patients (rates: 53% vs 77% respectively (p=0.011). The rate of R-ALD was significantly lower only in the superior adjacent level for the C-ADR vs ACDF patients (36% vs 59%, p=0.0022), although R-ALD trended lower in C-ADR patients for the inferior adjacent level (C-ADR 34% vs ACDF 43% [p=0.21]). The ROM of the C-ADR at final follow up was found to significant correlate (inversely) with the rate of progressive R-ALD. Discs moving 0-3degree had a 68% rate of progressive R-ALD, while the rate was only 53% in discs moving 4-6degree, and only 43% in discs moving 7degree or more (p=0.0113). Severe progression of R-ALD (grade 0-1 initially, 3-4 at follow-up) in C-ADR patients was found in 45% of patients with discs moving 0-3degree, in no patients with discs moving 4-6degree, and in 9.5% of patients with discs moving 7+degree (p=0.002). CONCLUSIONS: Long term results demonstrated that the rate of progressive radiographic adjacent level disc degeneration was significantly lower in C-ADR patients as compared to ACDF patients. The rate of radiographic ALD in the C-ADR patients was found to correlate inversely with the final ROM of the C-ADR
EMBASE:72100272
ISSN: 1529-9430
CID: 1905532
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
Janssen, Michael E; Zigler, Jack E; Spivak, Jeffrey M; Delamarter, Rick B; Darden, Bruce V 2nd; Kopjar, Branko
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.
PMID: 26537161
ISSN: 1535-1386
CID: 1825582
A Review of Symptomatic Lumbosacral Transitional Vertebrae: Bertolotti's Syndrome
Jancuska, Jeffrey M; Spivak, Jeffrey M; Bendo, John A
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.
PMCID:4603258
PMID: 26484005
ISSN: 2211-4599
CID: 1809992