Faculty Bibliography

STUDY DESIGN: A retrospective subgroup analysis was performed on surgically treated patients from the lumbar spinal stenosis (SpS) arm of the Spine Patient Outcomes Research Trial (SPORT), randomized and observational cohorts. OBJECTIVE: To identify risk factors for reoperation in patients treated surgically for SpS and compare outcomes between patients who underwent reoperation with those that did not. SUMMARY OF BACKGROUND DATA: SpS is one of the most common indications for surgery in the elderly; however, few long-term studies have identified risk factors for reoperation. METHODS: A post-hoc subgroup analysis was performed on patients from the SpS arm of the Spine Patient Outcomes Research Trial (SPORT), randomized and observational cohorts. Baseline characteristics were analyzed between reoperation and no reoperation groups using univariate and multivariate analysis on data eight years post-operation. RESULTS: Of the 417 study patients, 88% underwent decompression only, 5% non-instrumented fusion and 6% instrumented fusion. At the 8 year follow up, the reoperation rate was 18%; 52% of reoperations were for recurrent stenosis or progressive spondylolisthesis, 25% for complication or other reason and 16% for new condition. Of patients who underwent a reoperation, 42% did so within 2 yrs, 70% within 4 years and 84% within 6 years. Patients who underwent reoperation were less likely to have presented with any neurological deficit (43% reop vs. 57% no reop, p = 0.04). Patients improved less at follow-up in the re-operation group (p < 0.001). CONCLUSION: In patients undergoing surgical treatment for SpS, the reoperation rate at eight year follow-up was 18%. Patients with a reoperation were less likely to have a baseline neurological deficit. Patients who did not undergo reoperation had better patient reported outcomes at eight year follow up compared to those who had repeat surgery. LEVEL OF EVIDENCE: 2.

BACKGROUND CONTEXT: Surgical management for the treatment of cervical spondylotic myelopathy (CSM) has been extensively documented and supported in recent literature. However, less is known regarding the risk associated with surgical treatment for CSM and factors influencing the development of postoperative surgical complications, which commonly range from 5%-10%. Similarly, the link between nonoperative modalities and associated factors on patient outcomes remains unclear. PURPOSE: This study aimed to investigate risk factors and impact on health related quality of life (HRQL) scores from baseline to 2 years postoperative among CSM surgical patients. STUDY DESIGN/SETTING: Retrospective review of a prospectively collected multicenter database. PATIENT SAMPLE: 203 surgical CSM patients were identified. OUTCOME MEASURES: Primary Measures: Baseline patient demographics, comorbidities, clinical information, nonoperative treatment modalities, surgical procedures and complication rates. Secondary Measures: HRQL data at two years postoperative, including SF-36 Physical (PCS) and Mental (MCS) Component Scores, and Neck Disability Index (NDI) scores. METHODS: A retrospective review performed on a prospectively collected database of CSM patients. Baseline patient demographics, comorbidities, clinical information, nonoperative treatment modalities, surgical procedures, and complication rates were collected. Health-related quality of life (HRQOL) outcomes assessed by SF-36 PCS, SF-36 MCS and NDI at baseline and two years postoperatively. Statistical analyses included paired sample t-tests and multivariate logistic regression controlling for age, gender, BMI. RESULTS: 203 CSM patients receiving surgical treatment were identified (43% female). The average age was 57.7 years and average BMI was 29.6 kg/m2. Prior to surgical intervention, patients underwent numerous forms of nonoperative treatment modalities: NSAIDs (34%), analgesics (32%) and physical therapy (26%) displayed the highest prevalence among the total cohort. The total complication rate was 7.4%. Notable complications included CSF leak (2.5%), other (unspecified) complications (2.5%), postoperative radiculopathy (1.0%) and excessive bleeding (1.0%). Only a previous history of cervical spine surgery was identified as the only significant positive risk factor for developing a complication (OR: 9.22, p=0.034). The average HRQL patient scores significantly improved for SF-36 PCS, SF- 36 MCS and NDI, from baseline to two years postoperatively (p<0.001). CONCLUSIONS: The total complication rate was 7.4% for CSM surgical patients. Baseline clinical information, comorbidities, use of nonoperative treatment modalities and surgical procedures were not significantly associated with increased risk of complication development. However, previous cervical spine surgeries increased the risk of complications nine-fold. Surgical patients also significantly improved in SF-36 PCS, MCS and NDI scores two years after surgery

BACKGROUND CONTEXT: Optimal treatment algorithms have been extensively researched, particularly in the setting of a changing health care insurance system focused on efficient patient care. The effect of nonoperative treatment modalities prior to surgery on patient outcomes in the cervical population remains unknown. PURPOSE: The purpose of this study was to investigate recent trends in the preoperative treatment modalities administered to patients that, despite such interventions, go on to require surgical intervention of the cervical spine. We further aimed to determine whether specific nonoperative treatment modalities prior to surgery affect operative data, patient reported outcomes and the rate at which patients return to work. STUDY DESIGN/SETTING: This study performed a retrospective review of a prospectively collected multicenter database. PATIENT SAMPLE: 1,522 patients with 1- to 2-level surgical cervical pathology and < Grade 1 spondylolisthesis were included. OUTCOME MEASURES: Outcome measures included health-related quality of life (HRQL) scores (SF-36 and NDI), length of hospitalization (LOH), and return-to-work status at 2 weeks, 6 months, 1 year and 2 years. METHODS: Patients were grouped based on diagnosis (degenerative, including radiculopathy, vs myelopathy). Within each cohort, patients were divided further into whether they received epidural injection(s), physical therapy or narcotics prior to enrollment. Univariate analyses identified variables associated with outcomes. RESULTS: 34% of patients received physical therapy (PT), 34% received narcotics and 24% received epidural injections preoperatively. Among 1,319 radiculopathy patients, 25.7% received preop epidural injections, 35.3% received PT and 35.5% received narcotics. These patients had greater baseline (BL) to 2 year improvements in SF-36 Role Emotional Norm, Mental Health Norm and MCS, and had a higher incidence of return to work at 1 year postop (p<0.05). Patients without PT had longer LOH, while those who received PT had higher SF-36 Physical Functioning, Role Physical, General Health, PCS scores at 2 years, and had a higher incidence of returning to work at 2 years (p<0.05). 203 myelopathy patients were identified, 14.8% of whom received epidurals, 25.1% received narcotics and 41.5% received PT. Myelopathy patients who did not receive epidurals had higher Mental Health Norm scores (p<0.05). Patients who did not undergo PT had higher SF-36 Vitality Norm scores (p<0.05). Patients receiving narcotics were younger and had greater improvement in BL-2 year NDI (p<0.05). CONCLUSIONS: Among patients with a diagnosis of degenerative cervical pathology, epidural usage preoperatively was associated with greater improvements in SF-36 Role Emotional Norm, Mental Health Norm, and MCS scores at 2 years postoperatively, and a larger percentage of patients who received epidurals returned to work after one year. Physical therapy was associated with shorter hospitalizations, greater improvements in SF-36 Bodily Pain Norm and PCS scores, and a larger percentage of PT patients returned to work after one and two years. Contrarily, among patients with myelopathy, neither epidurals, PT, nor narcotics were associated with differences in the rates that patients returned to work. These findings suggest that certain nonoperative treatment modalities prior to surgery may help improve patient outcomes

BACKGROUND: Lumbar discectomy and laminectomy in patients with intervertebral disc herniation (IDH) is common, with variable reported reoperation rates. Our study examined which baseline characteristics might be risk factors for reoperation and compared outcomes between patients who underwent reoperation and those who did not. METHODS: We performed a retrospective subgroup analysis of patients from the IDH arm of the Spine Patient Outcomes Research Trial (SPORT) randomized and observational cohorts. We analyzed baseline characteristics and outcomes of patients who underwent reoperation and those who did not with use of data collected from enrollment through eight-years of follow-up after surgery. Follow-up times were measured from the time of surgery, and baseline covariates were updated to the follow-up immediately preceding the time of surgery for outcomes analyses. RESULTS: At eight years, the reoperation rate was 15% (691 no reoperation; 119 reoperation). Sixty-two percent of these patients underwent reoperation because of a recurrent disc herniation; 25%, because of a complication or other factor; and 11%, because of a new condition. The proportion of reoperations that were performed for a recurrent disc herniation ranged from 58% to 62% in the individual years. Older patients were less likely to have reoperation (p = 0.015), as were patients presenting with asymmetric motor weakness at baseline (p = 0.0003). Smoking, diabetes, obesity, Workers' Compensation, and clinical depression were not associated with a greater risk of reoperation. Scores on the Short Form (SF)-36 for bodily pain and physical functioning, the Oswestry Disability Index (ODI), and the Sciatica Bothersomeness Index as well as satisfaction with symptoms had improved less at the time of follow-up in the reoperation group (p < 0.001). CONCLUSIONS: In patients who underwent surgery for IDH, the overall reoperation rate was 15% at the eight-year follow-up. Patients of older age and patients presenting with asymmetric motor weakness were less likely to undergo a reoperation. Less improvement in patient-reported outcomes was noted in the reoperation group. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

BACKGROUND CONTEXT: Surgery for degenerative spondylolisthesis (DS) is common with good clinical outcomes. Several high quality studies have examined outcomes following DS surgery, but few have identified risk factors for re-operation. PURPOSE: To investigate the incidence of re-operation and associated risk factors among the surgically treated patients from the DS arm of the Spine Patient Outcomes Research Trial (SPORT), randomized and observational cohorts. Our study hypothesis was that certain patient characteristics would emerge as risk factors for re-operation. STUDY DESIGN/SETTING: A retrospective subgroup analysis of the 8- year data from the SPORT trial. PATIENT SAMPLE: 406 patients who underwent surgery for DS. OUTCOME MEASURES: Incidence of re-operation, risk factors. METHODS: A retrospective subgroup analysis was performed on surgically treated patients enrolled in the DS arm of the multicenter SPORT trial, randomized and observational cohorts. Included patients had neurogenic claudication for at least 12 weeks, clinical neurological signs, spinal stenosis on cross-sectional imaging, and DS on standing lateral radiographs. In our subgroup analysis, patients were stratified into no re-operation versus re-operation. Baseline characteristics were analyzed using multivariate regression from data collected from patients at eight years postoperatively. A Cox regression model Stepwise Method was implemented in SAS with p=0.10 significant for entry and p=0.05 significant for retention with calculation of hazard ratios (HR). RESULTS: Of the 406 surgery patients, 73% underwent instrumented fusion, 21% non-instrumented fusion, and 6% decompression alone. At 8 years, the re-operation rate was 22%, 315 having no re-operation and 91 in the re-operation group. Twenty-five (28%) were within the first year, 49 (54%) within 2 years, 64 (70%) within 4 years, and 78 (86%) within 6 years. Forty-one revisions (10%) were for progressive DS, 33 (8%) for complication or other reason, and 13 (3%) for a new co!

BACKGROUND CONTEXT: Lumbar spinal stenosis (SpS) is a common degenerative disease involving narrowing of the spinal canal that may lead to pain and disability. Spinal stenosis is the most common indication for surgery in the elderly population and was the fastest growing spine surgery in the last three decades. Prospective studies have shown that timely surgical intervention can be effective in restoring function in these patients, with variable re-operation rates. Few long-term studies have identified consistent risk factors for re-operation following surgery for SpS. PURPOSE: To investigate the incidence of re-operation and associated risk factors among the surgically treated patients from the SpS arm of the Spine Patient Outcomes Research Trial (SPORT), randomized and observational cohorts. Our study hypothesis was that specific patient baseline characteristics would emerge as risk factors for re-operation in patients treated surgically for SpS. STUDY DESIGN/SETTING: A retrospective subgroup analysis of the eight-year data from the SPORT trial. PATIENT SAMPLE: 417 patients who underwent surgery for SpS. OUTCOME MEASURES: Incidence of re-operation, risk factors. METHODS: A retrospective subgroup analysis was performed on surgically treated patients enrolled in the SpS arm of the multicenter SPORT trial randomized and observational cohorts. Patients included in the SpS arm had neurogenic claudication for at least 12 weeks and spinal stenosis, without spondylolisthesis or instability, as confirmed on imaging. In our subanalysis, patients were stratified into no re-operation versus reoperation. Baseline characteristics were analyzed using a multivariate regression analysis based on data collected from patients at eight years postoperatively. A Cox regression model Stepwise Method was implemented in SAS with p=0.10 significant for entry and p=0.05 significant for retention to the model. RESULTS: Of the 417 surgery patients, 88% underwent decompression only, 6% noninstrumented fusion, and 6% instr!

BACKGROUND CONTEXT: Lumbar discectomy and laminectomy for patients with intervertebral disc herniations (IDH) is the most common spine surgery performed in the United States with variable reported reoperation rates. Though prospective studies have reported outcomes related to this patient population, few have examined risk factors for reoperation. PURPOSE: To investigate the incidence of re-operation and associated risk factors among the surgically treated patients from the IDH arm of the Spine Patient Outcomes Research Trial (SPORT), randomized and observational cohorts. Our study hypothesis was that specific patient baseline characteristics would emerge as risk factors for re-operation in patients treated surgically for IDH. STUDY DESIGN/SETTING: A retrospective subgroup analysis of the eight-year data from the SPORT trial. PATIENT SAMPLE: 810 patients who underwent surgery for IDH. OUTCOME MEASURES: Incidence of re-operation, risk factors. METHODS: A retrospective subgroup analysis was performed on surgically treated patients enrolled in the IDH arm of the multicenter SPORT trial, randomized and observational cohorts. Patients included in the IDH arm had radicular pain for at least six weeks, clinical evidence of nerveroot irritation, and imaging showing a disc herniation at a level and side consistent with the patient's symptoms. In our subgroup analysis patients were stratified into no re-operation versus re-operation. Baseline characteristics were analyzed using a multivariate regression analysis based on data collected from patients at eight years postoperatively. A Cox regression model Stepwise Method was implemented in SAS with p=0.10 significant for entry and p=0.05 significant for retention to the model with calculation of hazard ratios (HR). RESULTS: At eight years, the re-operation rate was 14.6% with 691 having no re-operation and 119 in the re-operation group. Forty-eight (40%) patients underwent re-operation within the first year, 66 (55%) at two years, 85 (71%) at four years, 1!

BACKGROUND: Cervical drains have historically been used to avoid postoperative wound and respiratory complications such as excessive edema, hematoma, infection, re-intubation, delayed extubation, or respiratory distress. Recently, some surgeons have ceased using drains because they may prolong hospital stay, operative time, or patient discomfort. The objective of this retrospective case-control series is to investigate the effectiveness of postoperative drains following one- and two-level cervical fusions. METHODS: A chart review was conducted at a single institution from 2010-2013. Outcome measures included operative time, hospital stay, estimated blood loss and incidence of wound complications (infection, hematoma, edema, and complications with wound healing or evacuation), respiratory complications (delayed extubation, re-intubation, and respiratory treatment), and overall complications (wound complications, respiratory complications, dysphagia, and other complications). Statistical analyses including independent samples t-test, chi-square, analysis of covariance, and linear regression were used to compare patients who received a postoperative drain to those who did not. RESULTS: The study population included 39 patients who received a postoperative drain and 42 patients who did not. There were no differences in demographics between the two groups. Patients with drains showed increased operative time (100.1 vs 69.3 min, p < 0.001), hospital stay (38.9 vs. 31.7 hrs, p = 0.021), and blood loss (62.7 vs 29.1 mL, p < 0.001) compared to patients without drains. The frequency of wound complications, respiratory complications, and overall complications did not vary significantly between groups. CONCLUSIONS/LEVEL OF EVIDENCE: Cervical drains may not be necessary for patients undergoing one- and two-level cervical fusion. While there were no differences in incidence of complications between groups, patients treated with drains had significantly longer operative time and length of hospital stay. CLINICAL RELEVANCE: This could contribute to excessive costs for patients treated with drains, despite the lack of compelling evidence of the advantages of this treatment in the literature and in the current study.

BACKGROUND: Recent articles in the lay press and literature have raised concerns about the ability to report honest adverse event data from industry-sponsored spine surgery studies. To address this, clinical trials may utilize an independent Clinical Events Committee (CEC) to review adverse events and readjudicate the severity and relatedness accordingly. We are aware of no prior study that has quantified either the degree to which investigator bias is present in adverse event reporting or the effect that an independent CEC has on mitigating this potential bias. METHODS: The coflex Investigational Device Exemption study is a prospective randomized controlled trial comparing coflex (Paradigm Spine) stabilization with lumbar spinal fusion to treat spinal stenosis and spondylolisthesis. Investigators classified the severity of adverse events (mild, moderate, or severe) and their relationship to the surgery and device (unrelated, unlikely, possibly, probably, or definitely). An independent CEC, composed of three spine surgeons without affiliation to the study sponsor, reviewed and reclassified all adverse event reports submitted by the investigators. RESULTS: The CEC reclassified the level of severity, relation to the surgery, and/or relation to the device in 394 (37.3%) of 1055 reported adverse events. The proportion of adverse events that underwent reclassification was similar in the coflex and fusion groups (37.9% compared with 36.0%, p = 0.56). The CEC was 5.3 (95% confidence interval [CI], 2.6 to 10.7) times more likely to upgrade than downgrade the adverse event. The CEC was 7.3 (95% CI, 5.1 to 10.6) times more likely to upgrade than downgrade the relationship to the surgery and 11.6 (95% CI, 7.5 to 18.8) times more likely to upgrade than downgrade the relationship to the device. The status of the investigator's financial interest in the company had little effect on the reclassification of adverse events. CONCLUSIONS: Thirty-seven percent of adverse events were reclassified by the CEC; the large majority of the reclassifications were an upgrade in the level of severity or a designation of greater relatedness to the surgery or device. CLINICAL RELEVANCE: An independent CEC can identify and mitigate potential inherent investigator bias and facilitate an accurate assessment of the safety profile of an investigational device, and a CEC should be considered a requisite component of future clinical trials.