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Zoher Ghogawala, Christopher I. Shaffrey, Anthony L. Asher, Robert F. Heary, Tanya Logvinenko, Neil R. Malhotra, Stephen J. Dante, R. John Hurlbert, Andrea F. Douglas, Subu N. Magge, Praveen V. Mummaneni, Joseph S. Cheng, Justin S. Smith, Michael G. Kaiser, Khalid M. Abbed, Daniel M. Sciubba, and Daniel K. Resnick

Object

There is significant practice variation and considerable uncertainty among payers and other major stakeholders as to whether many surgical treatments are effective in actual US spine practice. The aim of this study was to establish a multicenter cooperative research group and demonstrate the feasibility of developing a registry to assess the efficacy of common lumbar spinal procedures using prospectively collected patient-reported outcome measures.

Methods

An observational prospective cohort study was conducted at 13 US academic and community sites. Unselected patients undergoing lumbar discectomy or single-level fusion for spondylolisthesis were included. Patients completed the 36-item Short-Form Survey Instrument (SF-36), Oswestry Disability Index (ODI), and visual analog scale (VAS) questionnaires preoperatively and at 1, 3, 6, and 12 months postoperatively. Power analysis estimated a sample size of 160 patients: 125 patients with lumbar disc herniation, and 35 with lumbar spondylolisthesis. All patient data were entered into a secure Internet-based data management platform.

Results

Of 249 patients screened, there were 198 enrolled over 1 year. The median age of the patients was 45.0 years (49% female) for lumbar discectomy (n = 148), and 58.0 years (58% female) for lumbar spondylolisthesis (n = 50). At 30 days, 12 complications (6.1% of study population) were identified. Ten patients (6.8%) with disc herniation and 1 (2%) with spondylolisthesis required reoperation. The overall follow-up rate for the collection of patient-reported outcome data over 1 year was 88.3%. At 30 days, both lumbar discectomy and single-level fusion procedures were associated with significant improvements in ODI, VAS, and SF-36 scores (p ≤ 0.0002), which persisted over the 1-year follow-up period (p < 0.0001). By the 1-year follow-up evaluation, more than 80% of patients in each cohort who were working preoperatively had returned to work.

Conclusions

It is feasible to build a national spine registry for the collection of high-quality prospective data to demonstrate the effectiveness of spinal procedures in actual practice. Clinical trial registration no.: 01220921 (ClinicalTrials.gov).

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Paul E. Kaloostian, Jennifer E. Kim, Ali Bydon, Daniel M. Sciubba, Jean-Paul Wolinsky, Ziya L. Gokaslan, and Timothy F. Witham

Object

The authors describe the largest case series of 8 patients with intracranial hemorrhage (ICH) after spinal surgery and identify associated pre-, intra-, and postoperative risk factors in relation to outcome.

Methods

The authors retrospectively reviewed the cases of 8 patients treated over 16 years at a single institution and also reviewed the existing literature and collected demographic, treatment, and outcome information from 33 unique cases of remote ICH after spinal surgery.

Results

The risk factors most correlated with ICH postoperatively were the presence of a CSF leak intraoperatively and the use of drains postoperatively with moderate hourly serosanguineous output in the early postoperative period.

Conclusions

Intracranial hemorrhage is a rare complication of spinal surgery that is associated with CSF leakage and use of drains postoperatively, with moderate serosanguinous output. These associations do not justify a complete avoidance of drains in patients with CSF leakage but may guide the treating physician to keep in mind drain output and timing of drain removal, while noting any changes in neurological examination status in the meantime. Additionally, continued and worsening neurological symptoms after spinal surgery may warrant cranial imaging to rule out intracranial hemorrhage, usually within the first 24 hours after surgery. The presence of cerebellar hemorrhage and hydrocephalus indicated a trend toward worse outcome.

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Paul E. Kaloostian, Patricia L. Zadnik, Ahmed J. Awad, Edward McCarthy, Jean-Paul Wolinsky, and Daniel M. Sciubba

Resection of metastatic pheochromocytomas may be complicated by transient postoperative neurological deficits due to hypotension. The authors report the first case of en bloc excision of a spinal pheochromocytoma with associated long-term hypertensive management off all medication. Interestingly, this is the first case of transient hypotension following en bloc resection of pheochromocytoma associated with temporary hypotension-associated neurological decline that resolved completely after correction of hypotension postoperatively. A 23-year-old man with a prior adrenalectomy for pheochromocytoma presented with focal thoracic pain. He had a known T-10 vertebral body lesion for which he received chemotherapy and radiation therapy. Imaging demonstrated increased destruction of the T-10 vertebral body, which was concerning for tumor growth. The patient underwent angiographic embolization followed by single-stage posterior en bloc vertebrectomy with placement of a cage and posterior instrumentation and fusion without event. However, approximately 24 hours after surgery, the patient's systolic blood pressure was consistently no higher than 70 mm Hg. During this time, he began suffering from severe bilateral lower-extremity weakness. His systolic blood pressure increased with dopamine, and his strength immediately improved. The patient's oral regimen of adrenergic blockade was stopped, and he recovered without event. Since that time, the patient has been symptom free and requires no antihypertensive medication. The role of en bloc resection for metastatic lesions of the spine is controversial but may be warranted in cases of metastatic pheochromocytoma. En bloc resection avoids intralesional tumor resection and thus may help prevent complications of hypertensive crisis associated with hormonal secretion and extensive blood loss, which are not uncommon with pheochromocytoma resection surgeries. Additionally, the role of en bloc spondylectomy in this setting may allow for metabolic treatment as patients with actively secreting tumors may no longer require antiadrenergic medications.

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Mohamad Bydon, Risheng Xu, Kyriakos Papademetriou, Daniel M. Sciubba, Jean-Paul Wolinsky, Timothy F. Witham, Ziya L. Gokaslan, George Jallo, and Ali Bydon

Object

Unintended durotomies are a common complication of spine surgery and are often correlated with increased postoperative morbidity. Recently, ultrasonic bone curettes have been introduced in spine surgery as a possible alternative to the conventional high-speed drill, offering the potential for greater bone-cutting precision and less damage to surrounding soft tissues. To date, however, few studies have investigated the safety and efficacy of the ultrasonic bone curette in reducing the rates of incidental durotomy compared with the high-speed drill.

Methods

The authors retrospectively reviewed the records of 337 consecutive patients who underwent posterior cervical or thoracic decompression at a single institution between January 2009 and September 2011. Preoperative pathologies, the location and extent of spinal decompression, and the use of an ultrasonic bone curette versus the high-speed drill were noted. The rates of incidental durotomy, as well as hospital length of stay (LOS) and perioperative outcomes, were compared between patients who were treated using the ultrasonic bone curette and those treated using a high-speed drill.

Results

Among 88 patients who were treated using an ultrasonic bone curette and 249 who were treated using a high-speed drill, 5 (5.7%) and 9 (3.6%) patients had an unintentional durotomy, respectively. This finding was not statistically significant (p = 0.40). No patients in either cohort experienced statistically higher rates of perioperative complications, although patients treated using an ultrasonic bone curette tended to have a longer hospital LOS. This difference may be attributed to the fact that this series contained a statistically higher number of metastatic tumor cases (p < 0.0001) in the ultrasonic bone curette cohort, likely increasing the LOS for that patient population. In 13 patients, the dural defect was repaired intraoperatively. No patients who experienced an incidental durotomy had new-onset or permanent neurological deficits postoperatively.

Conclusions

The safety and efficacy of ultrasonic bone curettes in spine surgery has not been well established. This study shows that the ultrasonic bone curette has a similar safety profile compared with the high-speed drill, although both are capable of causing iatrogenic dural tears during spine surgery.

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Paul M. Arnold

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Patricia Zadnik, Rachel Sarabia-Estrada, Mari L. Groves, Camilo Molina, Christopher Jackson, Edward McCarthy, Ziya L. Gokaslan, Ali Bydon, Jean-Paul Wolinsky, Timothy F. Witham, and Daniel M. Sciubba

Object

Metastatic spine disease is prevalent in cancer victims; 10%–30% of the 1.2 million new patients diagnosed with cancer in the US exhibit spinal metastases. Unfortunately, treatments are limited for these patients, as disseminated disease is often refractory to chemotherapy and is difficult to treat with surgical intervention alone. New animal models that accurately recapitulate the human disease process are needed to study the behavior of metastases in real time.

Methods

In this study the authors report on a cell line that reliably generates bony metastases following intracardiac injection and can be tracked in real time using optical bioluminescence imaging. This line, RBC3, was derived from a metastatic breast adenocarcinoma lesion arising in the osseous spine of a rat following intracardiac injection of MDA-231 human breast cancer cells.

Results

Upon culture and reinjection of RBC3, a statistically significantly increased systemic burden of metastatic tumor was noted. The resultant spine lesions were osteolytic, as demonstrated by small animal CT scanning.

Conclusions

This cell line generates spinal metastases that can be tracked in real time and may serve as a useful tool in the study of metastatic disease in the spine.

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Hormuzdiyar H. Dasenbrock, Stephen P. Juraschek, Lonni R. Schultz, Timothy F. Witham, Daniel M. Sciubba, Jean-Paul Wolinsky, Ziya L. Gokaslan, and Ali Bydon

Object

Advocates of minimally invasive discectomy (MID) have promoted this operation as an alternative to open discectomy (OD), arguing that there may be less injury to the paraspinal muscles, decreased postoperative pain, and a faster recovery time. However, a recently published large randomized controlled trial (RCT) comparing these approaches reported inferior relief of leg pain in patients undergoing MID. The authors conducted a meta-analysis to evaluate complications and improvement in leg pain in patients with radiculopathy enrolled in RCTs comparing OD to MID.

Methods

The authors performed a literature search using Medline and EMBASE of studies indexed between January 1990 and January 2011. Predetermined RCT eligibility included the usage of tubular retractors during MID, a minimum follow-up duration of 1 year, and quantification of pain with the visual analog scale (VAS). Trials that only evaluated patients with recurrent disc herniation were excluded. Data on operative parameters, complications, and VAS scores of leg pain were extracted by 2 investigators. A meta-analysis was performed assuming random effects to determine the difference in mean change for continuous outcomes and the risk ratio for binary outcomes.

Results

Six trials comprising 837 patients (of whom 388 were randomized to MID and 449 were randomized to OD) were included. The mean operative time was 49 minutes during MID and 44 minutes during OD; this difference was not statistically significant. Incidental durotomies occurred significantly more frequently during MID (5.67% compared with 2.90% for OD; RR 2.05, 95% CI 1.05–3.98). Intraoperative complications (incidental durotomies and nerve root injuries) were also significantly more common in patients undergoing MID (RR 2.01, 95% CI 1.07–3.77). The mean preoperative VAS score for leg pain was 6.9 in patients randomized to MID and 7.2 in those randomized to OD. With long-term follow-up (1–2 years postoperatively), the mean VAS score improved to 1.6 in both the MID and OD cohorts. There was no significant difference in relief of leg pain between the 2 approaches with either short-term follow-up (2–3 months postoperatively, 0.81 points on the VAS, 95% CI −4.71 to 6.32) or long-term follow-up (2.64 on the VAS, 95% CI −2.15 to 7.43). Reoperation for recurrent herniation was more common in patients randomized to the MID group (8.50% compared with 5.35% in patients randomized to the OD group), but this difference was not statistically significant (RR 1.56, 95% CI 0.92–2.66). Total complications did not differ significantly between the operations (RR 1.50, 95% CI 0.97–2.33).

Conclusions

The current evidence suggests that both OD and MID lead to a substantial and equivalent long-term improvement in leg pain. Adequate decompression, regardless of the operative approach used, may be the primary determinant of pain relief—the major complaint of many patients with radiculopathy. Incidental durotomies occurred significantly more frequently during MID, but total complications did not differ between the techniques.

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Camilo A. Molina, Rachel Sarabia-Estrada, Ziya L. Gokaslan, Timothy F. Witham, Ali Bydon, Jean-Paul Wolinsky, and Daniel M. Sciubba

Object

Recombinant human bone morphogenetic proteins (rhBMPs) are FDA-approved for specific spinal fusion procedures, but their use is contraindicated in spine tumor resection beds because of an unclear interaction between tumor tissue and such growth factors. Interestingly, a number of studies have suggested that BMPs may slow the growth of adenocarcinomas in vitro, and these lesions represent the majority of bony spine tumors. In this study, the authors hypothesized that rhBMP-2 placed in an intraosseous spine tumor in the rat could suppress tumor and delay the onset of paresis in such animals.

Methods

Twenty-six female nude athymic rats were randomized into an experimental group (Group 1) or a positive control group (Group 2). Group 1 (tumor + 15 μg rhBMP-2 sponge, 13 rats) underwent transperitoneal exposure and implantation of breast adenocarcinoma (CRL-1666) into the L-6 spine segment, followed by the implantation of a bovine collagen sponge impregnated with 15 μg of rhBMP-2. Group 2 (tumor + 0.9% NaCl sponge, 13 rats) underwent transperitoneal exposure and tumor implantation in the lumbar spine but no local treatment with rhBMP-2. An additional 8 animals were randomized into 2 negative control groups (Groups 3 and 4). Group 3 (15 μg rhBMP-2 sponge, 4 rats) and Group 4 (0.9% NaCl sponge, 4 rats) underwent transperitoneal exposure of the lumbar spine along with the implantation of rhBMP-2– and saline-impregnated bovine collagen sponges, respectively. Neither of the negative control groups was implanted with tumor. The Basso-Beattie-Bresnahan (BBB) scale was used to monitor daily motor function regression and the time to paresis (BBB score ≤ 7).

Results

In comparison with the positive control animals (Group 2), the experimental animals (Group 1) had statistically significant longer mean (25.8 ± 12.2 vs 13 ± 1.4 days, p ≤ 0.001) and median (20 vs 13 days) times to paresis. In addition, the median survival time was significantly longer in the experimental animals (20 vs 13.5 days, p ≤ 0.0001). Histopathological analysis demonstrated bone growth and tumor inhibition in the experimental animals, whereas bone destruction and cord compression were observed in the positive control animals. Neither of the negative control groups (Groups 3 and 4) demonstrated any evidence of neurological deterioration, morbidity, or cord compromise on either gross or histological analysis.

Conclusions

This study shows that the local administration of rhBMP-2 (15 μg, 10 μl of 1.5-mg/ml solution) in a rat spine tumor model of breast cancer not only fails to stimulate local tumor growth, but also decreases local tumor growth and delays the onset of paresis in rats. This preclinical experiment is the first to show that the local placement of rhBMP-2 in a spine tumor bed may slow tumor progression and delay associated neurological decline.

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Camilo Molina, Daniel M. Sciubba, Christopher Chaput, P. Justin Tortolani, George I. Jallo, and Ryan M. Kretzer

Object

Translaminar screws (TLSs) were originally described as a safer alternative to pedicle and transarticular screw placement at C-2 in adult patients. More recently, TLSs have been used in both the cervical and thoracic spine of pediatric patients as a primary fixation technique and as a bailout procedure when dysplastic pedicle morphology prohibits safe pedicle screw placement. Although authors have reported the anatomical characteristics of the cervical and thoracic lamina in adults as well as those of the cervical lamina in pediatric patients, no such data exist to guide safe TLS placement in the thoracic spine of the pediatric population. The goal of this study was to report the anatomical feasibility of TLS placement in the thoracic spine of pediatric patients.

Methods

Fifty-two patients (26 males and 26 females), with an average age of 9.5 ± 4.8 years, were selected by retrospective review of a trauma registry database after institutional review board approval. Study inclusion criteria were an age from 2 to 16 years, standardized axial bone-window CT images of the thoracic spine, and the absence of spinal trauma. For each thoracic lamina the following anatomical features were measured using eFilm Lite software: laminar width (outer cortical and cancellous), laminar height (LH), maximal screw length, and optimal screw trajectory. Patients were stratified by age (an age < 8 versus ≥ 8 years) and sex.

Results

Collected data demonstrate the following general trends as one descends the thoracic spine from T-1 to T-12: 1) increasing laminar width to T-4 followed by a steady decrease to T-12, 2) increasing LH, 3) decreasing maximal screw length, and 4) increasing ideal screw trajectory angle. When stratified by age and sex, male patients older than 8 years of age had significantly larger laminae in terms of both width and height and allowed significantly longer screw placement at all thoracic levels compared with their female counterparts. Importantly, it was found that 78% of individual thoracic laminae, regardless of age or sex, could accept a 4.0-mm screw with 1.0 mm of clearance. As expected, when stratifying by age and sex, it was found that older male patients had the highest acceptance rates.

Conclusions

Data in the present study provide information regarding optimal TLS length, diameter, and trajectory for each thoracic spinal level in pediatric patients. Importantly, the data collected demonstrate no anatomical limitations within the pediatric thoracic spine to TLS instrumentation, although acceptance rates are lower for younger (< 8 years old) and/or female patients. Lastly, given the anatomical variation found in this study, CT scanning can be useful in the preoperative setting when planning TLS use in the thoracic spine of pediatric patients.