Cervical orthosis does not improve postoperative pain following posterior cervical fusion: a randomized controlled trial.

PURPOSE: To determine whether postoperative neck pain in the first 4 weeks following multi-level posterior cervical fusion (PCF) with orthosis is equivalent to multi-level PCF without orthosis. METHODS: Patients were randomly assigned in a 1:1 ratio to postoperative orthosis (CO) for 6 weeks or no orthosis (NO). Randomization was stratified by indication (traumatic vs. degenerative), and preoperative opioid use. A model of longitudinal regression for repeated measures was used. The two-sided 95% confidence interval (CI) was used to test equivalence. If the CI lay between the pre-determined margin of equivalence (-2.0 to + 2.0 pain score) the two groups were considered equivalent. A multiple imputation procedure was used to replace missing data. RESULTS: Thirty-one patients were enrolled in each group. At baseline, the CO group had more neck pain (5.3 vs. 3.2, p = 0.013). The Four week post-operative neck pain intensity score was 4.6 ± 0.3 for the CO group vs. 4.9 ± 0.3 for the NO group. The 95% confidence interval (-1.2 to 0.6) was within the pre-determined equivalence margin. Neck Disability Index, quality-of-life scores, and arm pain were similar. Eleven patients in the CO group and 12 patients in the NO group had an adverse event. The CO group had reduced range of motion at 6 weeks. CONCLUSION: Pain scores over the first 4 weeks after surgery were equivalent for patients undergoing multi-level PCF treated with or without a cervical orthosis. Our findings do not support the routine use of a postoperative cervical orthosis for postoperative pain control. Clinical Trials Registration Number NCT04308122, April 22, 2020.

Characterizing mJOA-defined post-surgical recovery patterns in patients with degenerative cervical myelopathy.

Background: Degenerative cervical myelopathy is a spinal disorder resulting in progressive cord compression and neurological deficits that are assessed using the modified Japanese Orthopedic Association (mJOA) questionnaire. It is difficult to predict which patients will recover neurological function after surgery, making it challenging for clinicians to set postoperative patient expectations. In this study, we used mJOA subscores to identify patterns of recovery and recovery timelines in patients with moderate and severe myelopathy. Methods: Fifty-three myelopathy patients were enrolled and completed the mJOA questionnaire both pre-surgery, and six weeks and six months post-surgery. Pearson chi-square tests were performed to assess relationships of both recovery patterns and recovery timelines with severity of disease. Results: Moderate myelopathy patients were significantly more likely than severe myelopathy patients to experience full recovery of upper extremity, lower extremity, and sensory domains. Disease severity did not significantly impact the timeline during which recovery occurs. Overall, >90% of patients experienced at least partial recovery by six months post surgery, 80% of which demonstrated it within the first six weeks. Conclusions: This study shows the more severe the disease experienced by myelopathy patients, the more likely they will be left with permanent disabilities despite surgery. Early identification and treatment are therefore necessary to prevent worsening quality of life and increased costs of functional dependence. The recovery timelines for each subscore are similar and provide new values to guide patient expectations in their potential post-operative recovery. The overall recovery timeline is more generalizable though potentially lacking the specificity patients seek.

Early Versus Delayed Microdiscectomy for Chronic Sciatica Lasting 4-12 Months Secondary to Lumbar Disc Herniation: A Secondary Analysis of a Randomized Controlled Trial.

OBJECTIVES: To compare the effect of delaying surgery on clinical outcome in patients with chronic sciatica secondary to lumbar disc herniation. METHODS: Patients with sciatica lasting 4-12 months and lumbar disc herniation at the L4-L5 or L5-S1 level were randomized to undergo microdiscectomy (early surgery) or to receive 6 months of nonoperative treatment followed by surgery if needed (delayed surgery). Outcomes were leg pain, Oswestry Disability Index score (ODI), back pain, SF-36 physical component (PCS) and mental component (MCS) summary scores, employment, and satisfaction measured preoperatively and at 6 weeks, 3 months, 6 months, and 1 year after surgery. RESULTS: Of the 64 patients in the early surgery group, 56 underwent microdiscectomy an average of 3 ± 2 weeks after enrollment. Of the 64 patients randomized to nonoperative care, 22 patients underwent delayed surgery an average of 53 ± 24 weeks after enrollment. The early surgery group experienced less leg pain than the delayed surgery group, which was the primary outcome, at 6 months after surgery (early surgery 2.8 ± .4 vs delayed surgery 4.8 ± .7; difference, 2.0; 95% confidence interval, .5-3.5). The overall estimated mean difference between groups significantly favored early surgery for leg pain, ODI, SF36-PCS, and back pain. The adverse event rate was similar between groups. CONCLUSIONS: Patients presenting with chronic sciatica treated with delayed surgery after prolonging standardized non-operative care have inferior outcomes compared to those that undergo expedited surgery.

Microdiscectomy Is More Cost-effective Than a 6-Month Nonsurgical Care Regimen for Chronic Radiculopathy.

BACKGROUND: A recent randomized controlled trial (RCT), performed by the authors, comparing early surgical microdiscectomy with 6 months of nonoperative care for chronic lumbar radiculopathy showed that early surgery resulted in improved outcomes. However, estimates of the incremental cost-utility ratio (ICUR), which is often expressed as the cost of gaining one quality-adjusted life year (QALY), of microdiscectomy versus nonsurgical management have varied. Radiculopathy lasting more than 4 months is less likely to improve without surgical intervention and may have a more favorable ICUR than previously reported for acute radiculopathy. QUESTION/PURPOSE: In the setting of chronic radiculopathy caused by lumbar disc herniation, defined as symptoms and/or signs of 4 to 12 months duration, is surgical management more cost-effective than 6 months of nonoperative care from the third-party payer perspective based on a willingness to pay of less than CAD 50,000/QALY? METHODS: A decision analysis model served as the vehicle for the cost-utility analysis. A decision tree was parameterized using data from our single-center RCT that was augmented with institutional microcost data from the Ontario Case Costing Initiative. Bottom-up case costing methodology generates more accurate cost estimates, although institutional costs are known to vary. There were no major surgical cost drivers such as implants or bone graft substitutes, and therefore, the jurisdictional variance would be minimal for tertiary care centers. QALYs derived from the EuroQoL-5D were the health outcome and were derived exclusively from the RCT data, given the paucity of studies evaluating the surgical treatment of lumbar radiculopathy lasting 4 to 12 months. Cost-effectiveness was assessed using the ICUR and a threshold of willingness to pay CAD 50,000 (USD 41,220) per QALY in the base case. Sensitivity analyses were performed to account for the uncertainties within the estimate of cost utility, using both a probabilistic sensitivity analysis and two one-way sensitivity analyses with varying crossover rates after the 6-month nonsurgical treatment had concluded. RESULTS: Early surgical treatment of patients with chronic lumbar radiculopathy (defined as symptoms of 4 to 12 months duration) was cost-effective, in that the cost of one QALY was lower than the CAD 50,000 threshold (note: the purchasing power parity conversion factor between the Canadian dollar (CAD) and the US dollar (USD) for 2019 was 1 USD = 1.213 CAD; therefore, our threshold was USD 41,220). Patients in the early surgical treatment group had higher expected costs (CAD 4118 [95% CI 3429 to 4867]) than those with nonsurgical treatment (CAD 2377 [95% CI 1622 to 3518]), but they had better expected health outcomes (1.48 QALYs [95% CI 1.39 to 1.57] versus 1.30 [95% CI 1.22 to 1.37]). The ICUR was CAD 5822 per QALY gained (95% CI 3029 to 30,461). The 2-year probabilistic sensitivity analysis demonstrated that the likelihood that early surgical treatment was cost-effective was 0.99 at the willingness-to-pay threshold, as did the one-way sensitivity analyses. CONCLUSION: Early surgery is cost-effective compared with nonoperative care in patients who have had chronic sciatica for 4 to 12 months. Decision-makers should ensure adequate funding to allow timely access to surgical care given that it is highly likely that early surgical intervention is potentially cost-effective in single-payer systems. Future work should focus on both the clinical effectiveness of the treatment of chronic radiculopathy and the costs of these treatments from a societal perspective to account for occupational absences and lost patient productivity. Parallel cost-utility analyses are critical so that appropriate decisions about resource allocation can be made. LEVEL OF EVIDENCE: Level III, economic and decision analysis.

Discectomy Compared with Standardized Nonoperative Care for Chronic Sciatica Due to a Lumbar Disc Herniation: A Secondary Analysis of a Randomized Controlled Trial with 2-Year Follow-up.

BACKGROUND: Randomized controlled trials evaluating acute sciatica have not demonstrated prolonged improvements in terms of patient-reported pain and function. For chronic sciatica, however, microdiscectomy has been found to be superior at 1 year. Whether this effect persists during the second year is not known. The purpose of the present study was to report the 2-year outcomes following lumbar microdiscectomy as compared with standardized nonoperative care for the treatment of chronic sciatica resulting from a lumbar disc herniation. METHODS: The present study is a secondary analysis of a previously reported randomized controlled trial with extension to 2 years of follow-up. Patients with radiculopathy for 4 to 12 months resulting from an L4-L5 or L5-S1 disc herniation were randomized to microdiscectomy or 6 months of nonoperative care followed by surgery if needed. Intention-to-treat analysis was performed at 2 years for the primary outcome (the intensity of leg pain) (range of possible scores, 0 [no pain] to 10 [worst pain]) as well as for secondary outcomes (including the Oswestry Disability Index score, the intensity of back pain, and quality of life). RESULTS: One hundred and twenty-eight patients were randomized in the present study. Twenty-four (38%) of the 64 patients who had been randomized to nonoperative care crossed over to surgical treatment by 2 years following enrollment. At the 2-year time point, the follow-up rate was approximately 70%. At 2 years, the operative group had less leg pain than the nonoperative group (mean, 2.8 ± 0.4 compared with 4.2 ± 0.4; treatment effect, 1.3 [95% confidence interval, 0.3 to 2.4]). The treatment effect favored surgery for all secondary outcome measures at 6 months and 1 year and for back pain intensity and physical function at 2 years. CONCLUSIONS: At 2 years, the present study showed that microdiscectomy was superior to nonoperative care for the treatment of chronic sciatica resulting from an L4-L5 or L5-S1 disc herniation. However, the difference between the groups did not surpass the minimal clinically important difference at 2 years as was reached at earlier follow-up points, likely as the result of patients crossing over from nonoperative to operative treatment. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

The Impact of Surgical Site Infection on Patient Outcomes After Open Posterior Instrumented Thoracolumbar Surgery for Degenerative Disorders.

BACKGROUND: Few reports in the literature have described the long-term outcome of postoperative infection from the patient perspective. The aim of the present study was to determine if complicated surgical site infection (SSI) affects functional recovery and surgical outcomes up to 2 years after posterior instrumented thoracolumbar surgery for the treatment of degenerative disorders. METHODS: This retrospective cohort study involved patients who had been enrolled in a previous randomized controlled trial that examined antibiotic use for open posterior multilevel thoracolumbar or lumbar instrumented fusion procedures. In the present study, patients who had SSI (n = 79) were compared with those who did not (n = 456). Patient-reported outcome measures (PROMs) included the Oswestry Disability Index (ODI), leg and back pain scores on a numeric rating scale, Short Form-12 (SF-12) summary scores, and satisfaction with treatment at 1.5, 3, 6, 12, and 24 months. Surgical outcomes included adverse events, readmissions, and additional surgery. RESULTS: The median time to infection was 15 days. Of the 535 patients, 31 (5.8%) had complicated infections and 48 (9.0%) had superficial infections. Patients with an infection had a higher body mass index (BMI) (p = 0.001), had more commonly received preoperative vancomycin (p = 0.050), were more likely to have had a revision as the index procedure (p = 0.004), had worse preoperative mental functioning (mental component summary score, 40.7 ± 1.6 versus 44.1 ± 0.6), had more operatively treated levels (p = 0.024), and had a higher rate of additional surgery (p = 0.001). At 6 months after surgery, patients who developed an infection scored worse on the ODI by 5.3 points (95% confidence interval [CI], 0.4 to 10.1 points) and had worse physical functioning by -4.0 points (95% CI, -6.8 to -1.2 points). Comparison between the groups at 1 and 2 years showed no difference in functional outcomes, satisfaction with treatment, or the likelihood of achieving the minimum clinically important difference (MCID) for the ODI. CONCLUSIONS: SSI more than doubled the post-discharge emergency room visit and additional surgery rates. Patients with SSI initially (6 months) had poorer overall physical function representing the delay to recovery; however, the negative impact resolved by the first postoperative year. LEVEL OF EVIDENCE: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Biomechanical comparison of 3 types of transdiscal fixation implants for fixing high-grade L5/S1 spine spondylolisthesis.

BACKGROUND CONTEXT: There are several options for the stabilization of high-grade lumbosacral spondylolisthesis including transdiscal screws, the Bohlman technique (transdiscal fibular strut) and the modified Bohlman technique (transdiscal titanium mesh cage). The choice of an optimum construct remains controversial; therefore, we endeavoured to study and compare the biomechanical performance of these 3 techniques. PURPOSE: The aim of this study was to compare 3 types of transdiscal fixation biomechanically in an in vitro porcine lumbar-sacral spine model. STUDY DESIGN/SETTING: Porcine cadaveric biomechanical study. METHODS: 18 complete lumbar-sacral porcine spines were split into 3 repair groups, transdiscal screws (TS), Bohlman technique, and a modified Bohlman technique (MBT). Range of motion (L3 - S1) was measured in an intact and repaired state for flexion, extension, left/right lateral bending, and left/right torsion. To recreate a high-grade lumbosacral spondylolisthesis a bilateral L5/S1 facetectomy, removing the intervertebral disc completely, and the L5 body was displaced 50%-60% over the sacral promontory. Results were analyzed and compared to intact baseline measurements. Standard quasi-static moments (5 Nm) were applied in all modes. RESULTS: All range of motion (ROM) were in reference to intact baseline values. TS had the lowest ROM in all modes (p=.006-.495). Statistical difference was found only in extension for TS vs. BT (p=.011) and TS vs. MBT (p=.014). No bone or implant failures occurred. CONCLUSION: TS provided the lowest ROM in all modes of loading compared to Bohlman technique and MBT. Our study indicates that TS results in the most biomechanically stable construct. CLINICAL SIGNIFICANCE: Knowledge of the biomechanical attributes of various constructs could aid physicians in choosing a surgical construct for their patients.

The Development of Novel 2-in-1 Patient-Specific, 3D-Printed Laminectomy Guides with Integrated Pedicle Screw Drill Guides.

OBJECTIVE: To determine if 2-in-1 patient-specific laminectomy and drill guides can be safely used to perform laminectomy and pedicle screw insertion. METHODS: This was a cadaveric study designed to test novel 2-in-1 patient-specific laminectomy guides, with modular removable pedicle screw drill guides. Three-dimensional (3D) printing has not been applied to laminectomy. This cadaveric study tests novel 2-in-1 patient-specific laminectomy guides, with modular removable pedicle screw drill guides. Computed tomography (CT) scans of 3 lumbar spines were imported into 3D Slicer. Spinal models and patient-specific guides were created and 3D printed. The bones were cleaned to visualize and record the under surface of the lamina during laminectomy. Pedicle screws and laminectomies were performed with the aid of patient-specific guides. CT scans were performed to compare planned and actual screw and laminectomy positions. RESULTS: Thirty screws were inserted in 15 lumbar vertebrae by using the integrated 2-in-1 patient-specific drill guides. There were no cortical breaches on direct examination, or on postoperative CT. Digital video analysis revealed the burr tip did not pass deep to the inner table margin of the lamina in any of the 30 laminectomy cuts. Average surgical time was 4 minutes and 46 seconds (standard deviation, 1 min 38 sec). CONCLUSIONS: This study has explored the development of novel 2-in-1 patient-specific, 3D-printed laminectomy guides with integrated pedicle screw drill guides, which are accurate and safe in the laboratory setting. These instruments have the potential to simplify complex surgical steps, and improve accuracy, time, and cost.

Geometric and Volumetric Relationship Between Human Lumbar Vertebra and CT-based Models.

RATIONALE AND OBJECTIVES: Crucial to the process of three-dimensional (3D) printing is the knowledge of how the actual structure or organ relates dimensionally to its corresponding medical image. This study will examine the differences between human lumbar vertebrae, 3D scans of these bones, 3D models based on computed tomographic (CT) scans, and 3D-printed models. MATERIALS AND METHODS: CT scans were obtained for six human lumbar spines. The bones were cleaned, and 3D scanned. 3D mesh models were created from the CT data, and then 3D printed. Four models were analyzed: anatomic bones, 3D-scanned models, CT-models, and 3D-printed models. Manual measurements were performed for all model types, and segmentation metric comparisons were performed comparing the 3D-scanned models to the CT-models. RESULTS: There was no statistical difference between manual measurements when comparing each parameter of all model types, except for vertebral width (p = 0.044). There was no statistical difference when comparing the average of all measurements between all model types (p = 0.247). The mean Hausdorff distance was 0.99 mm (SD 0.55 mm) when comparing 3D-scanned model to CT-model. The mean Dice coefficient was 0.90 (SD 0.07) when comparing 3D-scanned model to CT-model. The mean volume for 3D-scanned model and CT-model were 41.6 ml and 45.9 ml (p < 0.001), respectively. CONCLUSION: This study clarifies the geometric and volumetric relationship between human lumbar vertebra and CT-based vertebral models. Segmentation metrics reveal a 1 mm difference between examined bones (using the 3D-scanned bone as a surrogate), and the CT measurements. This is confirmed by a volumetric difference of 4.3 ml, between the larger CT-based model and the smaller bone.

Surgery versus Conservative Care for Persistent Sciatica Lasting 4 to 12 Months.

BACKGROUND: The treatment of chronic sciatica caused by herniation of a lumbar disk has not been well studied in comparison with acute disk herniation. Data are needed on whether diskectomy or a conservative approach is better for sciatica that has persisted for several months. METHODS: In a single-center trial, we randomly assigned patients with sciatica that had lasted for 4 to 12 months and lumbar disk herniation at the L4-L5 or L5-S1 level in a 1:1 ratio to undergo microdiskectomy or to receive 6 months of standardized nonoperative care followed by surgery if needed. Surgery was performed by spine surgeons who used conventional microdiskectomy techniques. The primary outcome was the intensity of leg pain on a visual analogue scale (ranging from 0 to 10, with higher scores indicating more severe pain) at 6 months after enrollment. Secondary outcomes were the score on the Oswestry Disability Index, back and leg pain, and quality-of-life scores at 6 weeks, 3 months, 6 months, and 1 year. RESULTS: From 2010 through 2016, a total of 790 patients were screened; of those patients, 128 were enrolled, with 64 in each group. Among the patients assigned to undergo surgery, the median time from randomization to surgery was 3.1 weeks; of the 64 patients in the nonsurgical group, 22 (34%) crossed over to undergo surgery at a median of 11 months after enrollment. At baseline, the mean score for leg-pain intensity was 7.7 in the surgical group and 8.0 in the nonsurgical group. The primary outcome of the leg-pain intensity score at 6 months was 2.8 in the surgical group and 5.2 in the nonsurgical group (adjusted mean difference, 2.4; 95% confidence interval, 1.4 to 3.4; P<0.001). Secondary outcomes including the score on the Owestry Disability Index and pain at 12 months were in the same direction as the primary outcome. Nine patients had adverse events associated with surgery, and one patient underwent repeat surgery for recurrent disk herniation. CONCLUSIONS: In this single-center trial involving patients with sciatica lasting more than 4 months and caused by lumbar disk herniation, microdiskectomy was superior to nonsurgical care with respect to pain intensity at 6 months of follow-up. (Funded by Physicians' Services Incorporated Foundation; ClinicalTrials.gov number, NCT01335646.).

The Effect of Prolonged Postoperative Antibiotic Administration on the Rate of Infection in Patients Undergoing Posterior Spinal Surgery Requiring a Closed-Suction Drain: A Randomized Controlled Trial.

BACKGROUND: Closed-suction drains are frequently used following posterior spinal surgery. The optimal timing of antibiotic discontinuation in this population may influence infection risk, but there is a paucity of evidence. The aim of this study was to determine whether postoperative antibiotic administration for 72 hours (24 hours after drain removal as drains were removed on the second postoperative day) decreases the incidence of surgical site infection compared with postoperative antibiotic administration for 24 hours. METHODS: Patients undergoing posterior thoracolumbar spinal surgery managed with a closed-suction drain were prospectively randomized into 1 of 2 groups of postoperative antibiotic durations: (1) 24 hours, or (2) 24 hours after drain removal (72 hours). Drains were discontinued on the second postoperative day. The duration of antibiotic administration was not blinded. All subjects received a single dose of preoperative antibiotics, as well as intraoperative antibiotics if the surgical procedure lasted >4 hours. The primary outcome was the rate of complicated surgical site infection (deep or organ or space) within 1 year of the surgical procedure. RESULTS: The trial was terminated at an interim analysis, when 552 patients were enrolled, for futility with respect to the primary outcome. In this study, 282 patients were randomized to postoperative antibiotics for 24 hours and 270 patients were randomized to postoperative antibiotics for 72 hours. A complicated infection developed in 17 patients (6.0%) in the 24-hour group and in 14 patients (5.2%) in the 72-hour group (p = 0.714). The superficial infection rate did not differ between the groups (p = 0.654): 9.6% in the 24-hour group compared with 8.1% in the 72-hour group. Patients in the 72-hour group had a median hospital stay that was 1 day longer (p < 0.001). At 1 year, patient-rated outcomes including leg and back pain and physical and mental functioning were not different between the groups. CONCLUSIONS: The extension of postoperative antibiotics for 72 hours, when a closed-suction drain is required, was not associated with a reduction in the rate of complicated surgical site infection after posterior thoracolumbar spinal surgery. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of Levels of Evidence.

Posterolateral Versus Posterior Interbody Fusion in Lumbar Degenerative Spondylolisthesis.

STUDY DESIGN: This was a retrospective study of 2 different fusion techniques for the treatment of lumbar degenerative spondylolisthesis. OBJECTIVE: To determine whether posterior lumbar interbody fusion (IF) is associated with improved patient-rated satisfaction and functional outcome when compared with posterolateral fusion (PLF). SUMMARY OF BACKGROUND DATA: IF and PLF are widely used surgical approaches in the treatment of spondylolisthesis. Numerous studies have compared IF and PLF techniques, but inconsistent results, heterogeneous cohorts, and conflicting scientific evidence have made it difficult to reach a consensus on the optimal fusion technique. MATERIALS AND METHODS: A consecutive cohort of 87 patients who had single-level degenerative spondylolisthesis and either PLF or IF were identified from a prospectively maintained database. Short Form-36 physical and mental component score, Oswestry Disability Index, back and leg pain, and complication rate were assessed to 24 months postoperatively. Patient characteristics, clinical outcome, and complications were compared between groups. RESULTS: Of the 87 patients identified, 29 patients (33%) had PLF and 58 patients (67%) had IF. Patient follow-up was ≥85%. Foraminal stenosis (PLF, 13.8% vs. IF, 34.5%; P=0.046) was more common among the participants in the IF group. Intraoperative and postoperative complications were not different between groups (P>0.05). The reoperation rate was 3.4% in the PLF group and 10.3% in the IF group (P=0.416). Patients in the PLF group experienced similar gains in improvement in all outcome measures as those in the IF group (P>0.05). Four patients in the IF group and 3 in the PLF group were lacking evidence of radiographic fusion. These patients did have increased moderate back pain compared with patients demonstrating radiographic fusion but did not differ in any other postoperative outcomes measures. CONCLUSIONS: Type of fusion, IF or PLF, does not affect patient outcome or postoperative complication rates. LEVEL OF EVIDENCE: Level IV.

Quality of Life and Slip Progression in Degenerative Spondylolisthesis Treated Nonoperatively.

STUDY DESIGN: A prospective cohort study of consecutive patients. OBJECTIVE: Determination of the quality of life (QoL) and prevalence of slip progression in patients with degenerative lumbar spondylolisthesis managed nonoperatively. SUMMARY OF BACKGROUND DATA: Lumbar spinal stenosis secondary to degenerative lumbar spondylolisthesis is a common radiographic diagnosis associated with chronic back pain and radicular symptoms. There is limited evidence as to the clinical course in terms of validated QoL measures, and the extent of slip progression in patients with this condition treated nonoperatively. METHODS: Validated disease-specific and generic QoL metrics including SF12 physical and mental scores [SF12-physical component summary (PCS) and SF12-mental component summary (MCS)], Oswestry Disability Index (ODI), and numeric scales for back and leg pain as well as radiographic assessment of slip extent were evaluated at initial consultation (baseline) and at a minimum of 5 years after the baseline assessment. Slip progression was defined by a >5% increase in slip percentage. RESULTS: Thirty-nine of 160 (24.4%) patients elected to switch to operative management, despite no slip progression on preoperative radiographs. Seventy spondylolisthetic levels in 66 participants were assessed after a minimum of 5 years of nonoperative management. Twenty-one participants (31.8%) had slip progression. SF12-PCS, ODI, and leg pain improved similarly in both groups (P < 0.05). SF12-MCS did not change significantly in either group. Back pain improved only in the nonprogressing group. CONCLUSION: The majority of cases of low-grade spondylolisthesis do not progress over 5 years with nonoperative management. Regardless of whether there was progression or not, the mean PCS, ODI, and leg pain improved from baseline, although symptoms remained and a significant number elected to switch to surgical management before 5 years. Back pain improved with nonoperative treatment only in those without progression. LEVEL OF EVIDENCE: 2.

Obesity and spinal epidural lipomatosis in cauda equina syndrome.

BACKGROUND CONTEXT: Although lumbar disc herniations are common, only a small portion of these herniations lead to cauda equina syndrome (CES), which is an uncommon but debilitating disorder. Why some patients with herniation develop CES, when most do not, remains unknown. Preexisting subclinical epidural lipomatosis may limit canal space such that an otherwise benign herniation causes CES. PURPOSE: This study determines whether patients with an acute disc herniation and CES have a greater body mass index (BMI) and greater quantity of epidural fat compared with control subjects with non-CES symptomatic lumbar herniated discs. STUDY DESIGN/SETTING: A retrospective case-control series at a university-based level-1 trauma center was carried out. PATIENT SAMPLE: There were 33 CES and 66 control subjects identified from a prospectively maintained database of patients who underwent surgical management for a lumbar disc herniation between 2007 and 2012. Each CES case had two non-CES control patients matched by gender and age within 5 years except 5 CES cases that matched only one non-CES control. OUTCOME MEASURES: The outcome measures included weight, height, age, gender, and BMI. Radiographic outcome measures included the proportion of lumbar spinal canal occupied by fat and herniated disc on preoperative magnetic resonance imaging. METHODS: Patient charts and preoperative radiographs were retrospectively reviewed. For each patient, a blinded reviewer determined the proportion of lumbar spinal canal occupied by fat, and the maximal proportion of the canal occupied by herniated material at the involved level. Patient demographics and radiographic measures were compared between CES and control groups using chi-square or Student t tests. A second blinded reviewer re-assessed a series of radiographs, and the intraobserver variability was determined by Spearman correlation. Logistic regression was used to model the preoperative factors associated with having an acute disc herniation and CES. RESULTS: The CES cases had higher BMI (31.8 kg/m2, 95% confidence interval [CI] 29.5-34.0 vs. 28.1 kg/m2, 95% CI 26.7-29.5 in controls; p=.007), focally narrower canals (14.6 mm, 95% CI 13.8-15.3 mm vs. 16.4 mm, 95% CI 15.4-17.3 mm in controls; p=.003), and a greater percentage of spinal canal occupied by epidural fat (31.3%, 95% CI 26.1%-36.6% vs. 21.9%, 95% CI 18.7%-25.1% in controls; p=.003) and herniated disc material (54.5%, 95% CI 46.9%-62.0% vs. 34.4%, 95% CI 30.3%-38.5% in controls; p<.0001). Logistic regression confirmed canal width at the involved level, BMI, amount of canal occupied disc, and proportion of canal occupied by fat as independent predictors of having an acute disc herniation and CES. CONCLUSIONS: Obesity is a risk factor for CES from disc herniation. The CES cases also had a greater amount of herniated material, focally narrower canal, and larger epidural fat deposits. The latter may be the mechanism linking obesity with CES.

Patterns of C-2 fracture in the elderly: comparison of etiology, treatment, and mortality among specific fracture types.

OBJECTIVE Previous studies have focused on Type II odontoid fractures and have failed to report on the effect of other C-2 fracture types on treatment and outcome. The purpose of this study was to compare patient characteristics, cause of injury, predisposing factors to fracture, treatments, and mortality rates among C-2 fracture types in a cohort of elderly patients 70 years of age and older. METHODS A retrospective cohort study design was used. Patients who sustained a C-2 fracture between 2002 and 2011 and who were admitted to the authors' Level 1 trauma center were identified using the Discharge Abstract Database and the International Statistical Classification of Diseases and Related Health Problems (ICD-10) code S12.1. Fractures were classified as odontoid Type I, II, or III; hangman's; C-2 complex (hangman's appearance on sagittal images, Type III odontoid on coronal cuts); and other (miscellaneous). Age, sex, predisposing factors to falls, cause of injury, treatment, presence of autofusion in the subaxial cervical spine, and mortality rates were compared between fracture patterns. RESULTS One hundred forty-one patients were included; their mean age was 82 years. Fractures included Type II odontoid (57%), complex (19%), Type III odontoid (11%), hangman's (8%), and other (5%). Falls from a standing height accounted for 47% of injuries, and 65% of patients had ≥ 3 risk factors for falls. Subaxial autofusion was more common in odontoid fractures (p = 0.002). Treatment was mainly nonoperative (p < 0.0001). The 1-year mortality rate was 27%. Four patients died of spinal cord injury. CONCLUSIONS Although not as common as Type II odontoid fractures, other C-2 fractures including hangman's, complex, and Type III odontoid fractures accounted for close to half of the injuries in the study cohort. There were few differences between the fracture types with respect to cause of injury, predisposing factors, or mortality rate. However, surgical treatment was more common for Type II odontoid fractures.

Treatment of thoracolumbar burst fractures: extended follow-up of a randomized clinical trial comparing orthosis versus no orthosis.

OBJECTIVE A multicenter, prospective, randomized equivalence trial comparing a thoracolumbosacral orthosis (TLSO) to no orthosis (NO) in the treatment of acute AO Type A3 thoracolumbar burst fractures was recently conducted and demonstrated that the two treatments following an otherwise similar management protocol are equivalent at 3 months postinjury. The purpose of the present study was to determine whether there was a difference in long-term clinical and radiographic outcomes between the patients treated with and those treated without a TLSO. Here, the authors present the 5- to 10-year outcomes (mean follow-up 7.9 ± 1.1 years) of the patients at a single site from the original multicenter trial. METHODS Between July 2002 and January 2009, a total of 96 subjects were enrolled in the primary trial and randomized to two groups: TLSO or NO. Subjects were enrolled if they had an AO Type A3 burst fracture between T-10 and L-3 within the previous 72 hours, kyphotic deformity < 35°, no neurological deficit, and an age of 16-60 years old. The present study represents a subset of those patients: 16 in the TLSO group and 20 in the NO group. The primary outcome measure was the Roland Morris Disability Questionnaire (RMDQ) score at the last 5- to 10-year follow-up. Secondary outcome measures included kyphosis, satisfaction, the Numeric Rating Scale for back pain, and the 12-Item Short-Form Health Survey (SF-12) Mental and Physical Component Summary (MCS and PCS) scores. In the original study, outcome measures were administered at admission and 2 and 6 weeks, 3 and 6 months, and 1 and 2 years after injury; in the present extended follow-up study, the outcome measures were administered 5-10 years postinjury. Treatment comparison between patients in the TLSO group and those in the NO group was performed at the latest available follow-up, and the time-weighted average treatment effect was determined using a mixed-effects model of longitudinal regression for repeated measures averaged over all time periods. Missing data were assumed to be missing at random and were replaced with a set of plausible values derived using a multiple imputation procedure. RESULTS The RMDQ score at 5-10 years postinjury was 3.6 ± 0.9 (mean ± SE) for the TLSO group and 4.8 ± 1.5 for the NO group (p = 0.486, 95% CI -2.3 to 4.8). Average kyphosis was 18.3° ± 2.2° for the TLSO group and 18.6° ± 3.8° for the NO group (p = 0.934, 95% CI -7.8 to 8.5). No differences were found between the NO and TLSO groups with time-weighted average treatment effects for RMDQ 1.9 (95% CI -1.5 to 5.2), for PCS -2.5 (95% CI -7.9 to 3.0), for MCS -1.2 (95% CI -6.7 to 4.2) and for average pain 0.9 (95% CI -0.5 to 2.2). CONCLUSIONS Compared with patients treated with a TLSO, patients treated using early mobilization without orthosis maintain similar pain relief and improvement in function for 5-10 years.

Influence of postoperative sagittal balance and spinopelvic parameters on the outcome of patients surgically treated for degenerative lumbar spondylolisthesis.

OBJECTIVE The object of this study was to determine the association between postoperative sagittal spinopelvic alignment and patient-rated outcome measures following decompression and fusion for lumbar degenerative spondylolisthesis. METHODS The authors identified a consecutive series of patients who had undergone surgery for lumbar degenerative spondylolisthesis between 2008 and 2012, with an average follow-up of 3 years (range 1-6 years). Surgery was performed to address the clinical symptoms of spinal stenosis, not global sagittal alignment. Sagittal alignment was only assessed postoperatively. Patients were divided into 2 groups based on a postoperative sagittal vertical axis (SVA) < 50 mm (well aligned) or ≥ 50 mm (poorly aligned). Baseline demographic, procedure, and outcome measures were compared between the groups. Postoperative outcome measures and postoperative spinopelvic parameters were compared between groups using analysis of covariance. RESULTS Of the 84 patients included in this study, 46.4% had an SVA < 50 mm. Multiple levels of spondylolisthesis (p = 0.044), spondylolisthesis at the L3-4 level (p = 0.046), and multiple levels treated with fusion (p = 0.028) were more common among patients in the group with an SVA ≥ 50 mm. Patients with an SVA ≥ 50 mm had a worse SF-36 physical component summary (PCS) score (p = 0.018), a worse Oswestry Disability Index (ODI; p = 0.043), and more back pain (p = 0.039) than those with an SVA < 50 mm after controlling for multiple levels of spondylolisthesis and multilevel fusion. The spinopelvic parameters differing between the < 50-mm and ≥ 50-mm groups included lumbar lordosis (LL; 56.4° ± 4.7° vs 49.8° ± 4.3°, respectively, p = 0.040) and LL < pelvic incidence ± 9° (51% vs 23.1%, respectively, p = 0.013) after controlling for type of surgical procedure. CONCLUSIONS Data in this study revealed that patient-rated outcome is influenced by the overall postoperative sagittal balance as defined by the SVA.

A Multicenter Randomized Control Trial Comparing a Novel Intramedullary Device (InterTAN) Versus Conventional Treatment (Sliding Hip Screw) of Geriatric Hip Fractures.

OBJECTIVES: To compare outcomes in elderly patients with intertrochanteric hip fractures treated with either the sliding hip screw (SHS) or InterTAN intramedullary device (IT). DESIGN: Prospective, randomized, multicenter clinical trial. SETTING: Five level 1 trauma centers. PATIENTS: Two hundred forty-nine patients 55 years of age or older with AO/OTA 31A1 (43) and OA/OTA 31A2 (206) fractures were prospectively enrolled and followed for 12 months. INTERVENTION: Computer generated randomization to either IT (n = 123) or SHS (n = 126). MAIN OUTCOME MEASUREMENTS: The Functional Independence Measure (FIM) and the Timed Up and Go test (TUG) were used to measure function and motor performance. Secondary outcome measures included femoral shortening, complications, and mortality. RESULTS: Demographics, comorbidities, preinjury FIM scores and TUG scores were similar between groups. Patients (17.2%) who received an IT had limb shortening greater than 2 cm compared with 42.9% who received an SHS (P < 0.001). To determine the importance of preinjury function and fracture stability, we analyzed the subgroup of patients with the ability to walk 150 m independently preinjury and an OA/OTA 31A-2 fracture (n = 70). In this subgroup, patients treated with SHS had greater shortening and demonstrated poorer FIM and TUG scores compared with patients treated with an IT. CONCLUSIONS: Overall, most patients with intertrochanteric femur fractures can expect similar functional results whether treated with an intramedullary or extramedullary device. However, active, functional patients have an improved outcome when the InterTAN is used to treat their unstable intertrochanteric fracture. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Radiographic assessment of degenerative lumbar spinal stenosis: is MRI superior to CT?

OBJECTIVE: To determine the reliability and dependability of magnetic resonance imaging (MRI) and computerized tomography (CT) in the assessment of lumbar spinal stenosis and correlate the qualitative assessment to both a quantitative assessment and functional outcome measures. Multiple studies have addressed the issue of CT and MRI imaging in lumbar spinal stenosis. None showed superiority of one modality. METHODS: We performed a standardized qualitative and quantitative review of CT and MRI scans of 54 patients. Intra-observer and inter-observer reliability was determined between three reviewer using Kappa coefficient. Agreement between the two modalities was analyzed. ODI and SF-36 outcomes were correlated with the imaging assessments. RESULTS: Almost perfect intra-observer reliability for MRI was achieved by the two expert reviewers (κ = 0.91 for surgeon and κ = 0.92 for neuro-radiologist). For CT, substantial intra-observer agreement was found for the surgeon (κ = 0.77) while the neuro-radiologist was higher (κ = 0.96). For both CT and MRI the standardized qualitative assessment used by the two expert reviewers had a better inter-observer reliability than that between the expert reviewers and the general reporting radiologist, who did not utilize a standardized assessment system. When the qualitative assessment was compared directly, CT overestimated the degree of stenosis 20-35 % of the time (p < 0.05) while MRI overestimated the degree of stenosis 2-11 % of the time (p < 0.05). No correlation was found between qualitative and quantitative analysis with functional status. CONCLUSIONS: This study directly demonstrates that MRI is a more reliable tool than CT, but neither correlates with functional status. Both experience of the reader and the standardization of a qualitative assessment are influential to the reliability.

Does the wait for lumbar degenerative spinal stenosis surgery have a detrimental effect on patient outcomes? A prospective observational study.

BACKGROUND: Waits for elective spine surgery are common in Canada. We examined whether a prolonged wait for surgery for lumbar degenerative spinal stenosis was detrimental to outcome. METHODS: In this prospective observational study, we enrolled 166 consecutive patients referred to our centre for treatment of lumbar degenerative spinal stenosis between 2006 and 2010. Outcome measures were assessed at referral, preoperatively and until 24 months postoperatively. Primary outcome measures were the physical and mental component summary scores of the 36-Item Short-Form Health Survey and the Oswestry Disability Index. Secondary outcome measures included the symptom severity scale of the Zurich Claudication Questionnaire, a numeric rating scale for back and leg pain, and patient satisfaction with treatment. Wait time was defined as the time from referral to surgery. RESULTS: The follow-up rate at 2 years was 85%. The median wait time was 349 days. All health-related quality of life measures deteriorated during the waiting period, but there was no significant correlation between wait time and magnitude of the change in outcome measure. At 6 months postoperatively, the Pearson correlation was significantly positive between wait time and change in disability (r = 0.223), Zurich Claudication Questionnaire score (r = 0.2) and leg pain score (r = 0.221). At 12 months, the correlation remained significant for change in disability (r = 0.205) and was significant for change in mental well-being (r = -0.224). At 12 months, patients with a shorter wait (≤ 12 months) showed greater improvement in mental well-being (mean difference in change [and 95% confidence interval (CI)] 5.7 [1.4-9.9]) and decrease in disability (-9.3 [95% CI -15.1 to -3.6]) and leg pain (-1.6 [95% CI -3.0 to -0.3]). There were no statistically significant differences in outcome or patient satisfaction with treatment between those with shorter and longer waits at 24 months. INTERPRETATION: Patients awaiting spinal surgery experienced deterioration in health-related quality of life irrespective of the length of wait time. However, longer waits were associated with a delay in recovery during the first year after surgery.