Impact of surgical risk factors for non-union on lumbar spinal fusion outcomes using cellular bone allograft at 24-months follow-up.

BACKGROUND: The current report investigates fusion rates and patient-reported outcomes following lumbar spinal surgery using cellular bone allograft (CBA) in patients with risk factors for non-union. METHODS: A prospective, open label study was conducted in subjects undergoing lumbar spinal fusion with CBA (NCT02969616) to assess fusion success rates and patient-reported outcomes in subjects with risk factors for non-union. Subjects were categorized into low-risk (≤ 1 risk factors) and high-risk (> 1 risk factors) groups. Radiographic fusion status was evaluated by an independent review of dynamic radiographs and CT scans. Patient-reported outcome measures included quality of life (EQ-5D), Oswestry Disability Index (ODI) and Visual Analog Scales (VAS) for back and leg pain. Adverse event reporting was conducted throughout 24-months of follow-up. RESULTS: A total of 274 subjects were enrolled: 140 subjects (51.1%) were categorized into the high-risk group (> 1 risk factor) and 134 subjects (48.9%) into the low-risk group (≤ 1 risk factors). The overall mean age at screening was 58.8 years (SD 12.5) with a higher distribution of females (63.1%) than males (36.9%). No statistical difference in fusion rates were observed between the low-risk (90.0%) and high-risk (93.9%) groups (p > 0.05). A statistically significant improvement in patient-reported outcomes (EQ-5D, ODI and VAS) was observed at all time points (p < 0.05) in both low and high-risk groups. The low-risk group showed enhanced improvement at multiple timepoints in EQ-5D, ODI, VAS-Back pain and VAS-Leg pain scores compared to the high-risk group (p < 0.05). The number of AEs were similar among risk groups. CONCLUSIONS: This study demonstrates high fusion rates following lumbar spinal surgery using CBA, regardless of associated risk factors. Patient reported outcomes and fusion rates were not adversely affected by risk factor profiles. TRIAL REGISTRATION: NCT02969616 (21/11/2016).

Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusion.

BACKGROUND: Autologous bone grafts are the gold standard for spinal fusion; however, harvesting autologous bone can result in donor site infection, hematomas, increased operative time, and prolonged pain. Cellular bone allografts (CBAs) are a viable alternative that avoids the need for bone harvesting and may increase fusion success alone or when used as an adjunct material. The present study examined the efficacy and safety of CBA when used as an adjunct graft material to lumbar arthrodesis. METHODS: A prospective, single-arm, multicenter clinical trial (NCT02969616) was conducted in adult subjects (> 18 years of age) undergoing lumbar spinal fusion with CBA graft (CBA used as primary (≥ 50% by volume), with augmentation up to 50%). Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. Clinical outcomes were assessed with the Oswestry Disability Index (ODI), and Visual Analog Scales (VAS) score for back and leg pain. Adverse events were assessed through the 24-month follow-up period. The presented data represents an analysis of available subjects (n = 86) who completed 24 months of postoperative follow-up at the time the data was locked for analysis. RESULTS: Postoperative 24-month fusion success was achieved in 95.3% of subjects (n = 82/86) undergoing lumbar spinal surgery. Clinical outcomes showed statistically significant improvements in ODI (46.3% improvement), VAS-Back pain (75.5% improvement), and VAS-Leg pain (85.5% improvement) (p < 0.01) scores at Month 24. No subject characteristics or surgical factors were associated with pseudoarthrosis. A favorable safety profile with a limited number of adverse events was observed. CONCLUSIONS: The use of CBA as an adjunct graft material showed high rates of successful lumbar arthrodesis and significant improvements in pain and disability scores. CBA provides an alternative to autograft with comparable fusion success rates and clinical benefits. TRIAL REGISTRATION: NCT02969616.

High Lumbar Spinal Fusion Rates Using Cellular Bone Allograft Irrespective of Surgical Approach.

BACKGROUND: Mounting evidence demonstrates a promising safety and efficacy profile for spinal fusion procedures using cellular bone allograft (CBA). However, limited data exists on fusion outcomes stratified by surgical approach. The current study investigates the effectiveness of CBA in lumbar spinal fusion by surgical approach (ie, anterior, lateral, and posterior approaches). METHODS: Patients undergoing lumbar spinal fusion with CBA (Trinity Elite) were enrolled into a prospective, multi-center, open-label clinical study (NCT02969616). Fusion status was assessed by an independent review of dynamic radiographs and computed tomography images. Clinical outcome measures included quality of life (QoL; EQ5D), disability (Oswestry Disability Index [ODI]), and pain (visual analog scale [VAS]) for back pain and leg pain). Patient data extending to 24 months were analyzed in a post-hoc analysis. RESULTS: A total of 252 patients underwent interbody fusion (159 women; 93 men). Patients had a mean age of 58.3 years (SD 12.5), height of 168.3 cm (SD 10.2), and weight of 87.3 kg (SD 20.0) with a body mass index of 30.8 kg/m2 (SD 6.5). At 12 months, the overall fusion success rate for bridging bone was 98.5%; fusion success was 98.1%, 100.0%, and 97.9% for anterior, lateral, and posterior approaches, respectively. At 24 months, the overall fusion success rate for bridging bone was 98.9%; fusion success was 97.9%, 100.0%, and 98.8% for anterior, lateral, and posterior approaches, respectively. The surgical approach did not significantly impact fusion success. A significant (P < 0.0001) improvement in QoL, pain, and disability scores was also observed. Significant differences in the ODI, VAS, and EQ5D were observed between the treatment groups (P < 0.05). CONCLUSIONS: CBA represents an attractive alternative to autograft alone, reporting a high rate of successful fusion and clinical outcomes across various surgical approaches. CLINICAL RELEVANCE: The use of CBA for spinal fusion procedures, regardless of surgical approach, provides high rates of fusion with a favorable safety profile and improved patient outcomes. TRIAL REGISTRATION: NCT02969616.

Adjunctive Use of Bone Growth Stimulation Increases Cervical Spine Fusion Rates in Patients at Risk for Pseudarthrosis.

STUDY DESIGN: A prospective multicenter clinical trial (NCT03177473) was conducted with a retrospective cohort used as a control arm. OBJECTIVE: The purpose of this study was to evaluate cervical spine fusion rates in subjects with risk factors for pseudarthrosis who received pulsed electromagnetic field (PEMF) treatment. SUMMARY OF BACKGROUND DATA: Certain risk factors predispose patients to pseudarthrosis, which is associated with prolonged pain, reduced function, and decreased quality of life. METHODS: Subjects in the PEMF group were treated with PEMF for 6 months postoperatively. The primary outcome measure was fusion status at the 12-month follow-up period. Fusion status was determined using anterior/posterior, lateral, and flexion/extension radiographs and computed tomography (without contrast). RESULTS: A total of 213 patients were evaluated (PEMF, n=160; Control, n=53). At baseline, the PEMF group had a higher percentage of subjects who used nicotine ( P =0.01), had osteoporosis ( P <0.05), multi-level disease ( P <0.0001), and were >65 years of age ( P =0.01). The PEMF group showed over two-fold higher percentage of subjects that had ≥3 risk factors (n=92/160, 57.5%) compared with the control group (n=14/53, 26.4%). At the 12-month follow-up, the PEMF group demonstrated significantly higher fusion rates compared with the control (90.0% vs. 60.4%, P <0.05). A statistically significant improvement in fusion rate was observed in PEMF subjects with multi-level surgery ( P <0.0001) and high BMI (>30 kg/m 2 ; P =0.0021) when compared with the control group. No significant safety concerns were observed. CONCLUSIONS: Adjunctive use of PEMF stimulation provides significant improvements in cervical spine fusion rates in subjects having risk factors for pseudarthrosis. When compared with control subjects that did not use PEMF stimulation, treated subjects showed improved fusion outcomes despite being older, having more risk factors for pseudarthrosis, and undergoing more complex surgeries.

Minimally invasive lumbopelvic instrumentation for traumatic sacrolisthesis in an elderly patient.

PURPOSE: We present a novel minimally invasive technique for lumbopelvic instrumentation in selected elderly patients suffering from traumatic sacrolisthesis. An 82-year-old female suffered from sacrolisthesis after a fall. She developed significant low back pain and bilateral lower extremity radiculopathy. Preoperative radiographs and magnetic resonance imaging sequences demonstrated the fracture dislocation between S1 and S2 with compromise of the spinal canal. Lumbopelvic instrumentation was sought to offer fixation and allow mobilization; however, open lumbopelvic instrumentation techniques have significant morbidity, especially in this patient population of elderly patients with medical comorbidities. METHODS: A minimally invasive technique employing percutaneous pedicle screws at L5 and S1 coupled with percutaneous S2 iliac screws was employed. RESULTS AND CONCLUSIONS: The patient tolerated the procedure well without any complications or morbidity. At the last follow-up of 14 months, she was ambulating without assistance with near total resolution of back pain and radicular pain. Radiographs obtained at 8 months' follow-up demonstrated fusion across the fracture line. Although further follow-up data is still needed to establish the durability of this technique in the long-term, this minimally invasive technique for lumbopelvic instrumentation can be considered as an option in elderly patients with traumatic sacrolisthesis, whose need for early mobilization and medical comorbidities preclude the use of an open lumbopelvic fixation procedure.

Radiation necrosis following treatment of high grade glioma--a review of the literature and current understanding.

Radiation therapy is an integral part of the standard treatment paradigm for malignant gliomas, with proven efficacy in randomized control trials. Radiation treatment is not without risk however, and radiation injury occurs in a certain proportion of patients. Difficulties in differentiating recurrence from radiation injury complicate the treatment course and can compromise care. These complexities are compounded by the recent distinction of two types of radiation injury: pseudoprogression and radiation necrosis, which are likely the result of radiation injury to the tumor and normal tissue, respectively. A thorough understanding of radiation-induced injury offers insights to guide further therapies. We detail the current knowledge of the mechanisms of radiation injury, along with potential targets for therapeutic intervention. Various diagnostic modalities are also described, in addition to the multiple options for treatment within the context of their pathophysiology and clinical efficacy. Radiation therapy is an integral part of the multidisciplinary management of gliomas, and the optimal diagnosis and management of radiation injury is paramount to improving patient outcomes.

The translabyrinthine approach in residency training. "Step by step" surgical anatomy from the dissection laboratory to the operative room.

Surgical anatomy training in a dedicated research laboratory and attendance to focused "hands-on" dissection courses are of high educational importance in order to acquire and maintain surgical expertise in skull base surgery, both for young and more experienced surgeons. Nevertheless, transitioning surgical skills and anatomic knowledge from the laboratory to the operative room it is not free of challenges, especially during skull base approaches where the three-dimensional surgical orientation can be quite complex. We present a "step-by-step" and "side-by-side" surgical anatomy report on a translabyrinthine approach that was practiced in the laboratory then performed in the operative room by the surgical team, and we compare surgical anatomy exposures while discussing intraoperative techniques, nuances and challenges, both in the laboratory and the operative room.

Pathologic cervical burst fracture presenting with airway compromise.

Mechanical airway compromise following cervical spine injury or fracture is a rare but known entity. It most commonly is the result of the development of a retropharyngeal hematoma or prevertebral soft tissue edema that obstructs the airway, leading to respiratory distress and emergent need for airway management and possible surgical intervention. We present a novel case of airway compromise following a C3 burst fracture without associated retropharyngeal hematoma or prevertebral soft tissue edema. Surgical management is discussed, and a review of relevant literature is provided. Pathological cervical spine fracture must be included in the differential diagnosis of a patient presenting with acute airway obstruction of unknown etiology.

Lumbar Discectomy and Reoperation Among Workers' Compensation Cases in Florida and New York: Are Treatment Trends Similar to Other Payer Types?

OBJECTIVE: The aim of this study was to better understand current treatment trends and revision rates for lumbar disc herniation (LDH) in the workers' compensation (WC) population compared with other payer types. METHODS: This was a retrospective analysis of outpatient claims data from Florida and New York during 2014 to 2016. RESULTS: WC patients were less likely to undergo discectomy in Florida (15% vs 19%; P < 0.001) and New York (10% vs 15%; P < 0.001). The odds of WC patients undergoing revision discectomy were 1.5 times greater than patients covered by private payers or all other non-WC payers (P = 0.002). CONCLUSIONS: WC patients undergo discectomy significantly less often than non-WC counterparts, which may be related to a higher risk of reoperation. New evidence-based treatments, such as annular repair, may be critical to advancing care in this unique population.

From prefrontal leukotomy to deep brain stimulation: the historical transformation of psychosurgery and the emergence of neuroethics.

The history of psychosurgery is described and analyzed. This historical perspective largely begins with analysis of the work of Egas Moniz in the development of the leukotomy, and follows the rise and fall of its popularity in the 1900s. The reemergence of psychosurgical procedures and the development of new therapeutic technologies such as vagus nerve stimulation and deep brain stimulation are discussed. In addition, an introduction to the field of neuroethics is provided, given its importance in any discussion about surgical therapy for psychiatric patients.

Spontaneous encephaloceles of the temporal lobe.

Encephaloceles are pathological herniations of brain parenchyma through congenital or acquired osseus-dural defects of the skull base or cranial vault. Although encephaloceles are known as rare conditions, several surgical reports and clinical series focusing on spontaneous encephaloceles of the temporal lobe may be found in the otological, maxillofacial, radiological, and neurosurgical literature. A variety of symptoms such as occult or symptomatic CSF fistulas, recurrent meningitis, middle ear effusions or infections, conductive hearing loss, and medically intractable epilepsy have been described in patients harboring spontaneous encephaloceles of middle cranial fossa origin. Both open procedures and endoscopic techniques have been advocated for the treatment of such conditions. The authors discuss the pathogenesis, diagnostic assessment, and therapeutic management of spontaneous temporal lobe encephaloceles. Although diagnosis and treatment may differ on a case-by-case basis, review of the available literature suggests that spontaneous encephaloceles of middle cranial fossa origin are a more common pathology than previously believed. In particular, spontaneous cases of posteroinferior encephaloceles involving the tegmen tympani and the middle ear have been very well described in the medical literature.

Proton affinity of beta-oxalylaminoalanine (BOAA): incorporation of direct entropy correction into the single-reference kinetic method.

A new version of the single-reference-extended kinetic method is presented in which direct entropy correction is incorporated. Results of calibration experiments with the monodentate base pyridine and the bidentate base ethylenediamine are presented for which the method provides proton affinities in excellent agreement with published values and reasonable predictions for the protonation entropies. The method is then used to determine the proton affinity and protonation entropy of the non-protein amino acid beta-oxalylaminoalanine (BOAA). The PA of BOAA is found to be 933.1 +/- 7.8 kJ/mol and a prediction for the protonation entropy of -39 J mol(-1) K(-1) is also obtained, indicating a significant degree of intramolecular hydrogen bonding in the protonated form. These results are supported by hybrid density functional theory calculations at the B3LYP/6-311++G**//B3LYP/6-31+G* level. They indicate that the preferred site of protonation is the alpha-nitrogen atom (PA = 935.0 kJ/mol) and that protonated BOAA has a strong hydrogen bond between the hydrogen on the alpha-amino group and one of the carbonyl oxygen atoms on the side chain.

Resection of large vestibular schwannomas: facial nerve preservation in the context of surgical approach and patient-assessed outcome.

OBJECT: Vestibular schwannoma surgery has evolved as new therapeutic options have emerged, patients' expectations have risen, and the psychological effect of facial nerve paralysis has been studied. For large vestibular schwannomas for which extirpation is the primary therapy, the goals remain complete tumor resection and maintenance of normal neurological function. Improved microsurgical techniques and intraoperative facial nerve monitoring have decreased the complication rate and increased the likelihood of normal to near-normal postoperative facial function. Nevertheless, the impairment most frequently reported by patients as an adverse effect of surgery continues to be facial nerve paralysis. In addition, patient assessment has provided a different, less optimistic view of outcome. The authors evaluated the extent of facial function, timing of facial nerve recovery, patients' perceptions of this recovery and function, and the prognostic value of intraoperative facial nerve monitoring following resection of large vestibular schwannomas; they then analyzed these results with respect to different surgical approaches. METHODS: The authors retrospectively reviewed a database of 67 patients with 71 vestibular schwannomas measuring 3 cm or larger in diameter. The patients had undergone surgery via translabyrinthine, retrosigmoid, or combined approaches. Clinical outcomes were analyzed with respect to intraoperative facial nerve activity, responses to intraoperative stimulation, and time course of recovery. Eighty percent of patients obtained normal to near-normal facial function (House-Brackmann Grades I and II). Patients' perceptions of facial nerve function and recovery correlated well with the clinical observations. CONCLUSIONS: Trends in the data lead the authors to suggest that a retrosigmoid exposure, alone or in combination with a translabyrinthine approach, offers the best chance of facial nerve preservation in patients with large vestibular schwannomas.

Treatment of craniocervical instability using a posterior-only approach: report of 3 cases.

The object of this study was to demonstrate that a posterior-only approach for craniocervical junction pathology is feasible with intraoperative reduction. The authors reviewed 3 cases of craniocervical instability. All patients had craniocervical instability according to radiological imaging and various methods of measurement, with results outside the normal range. Posterior instrumentation aided the intraoperative reduction techniques while maintaining structural integrity and the desired fusion construct. No anterior approach was necessary in any of the patients. Neurological symptoms resolved in two patients and significantly improved in another. Follow-up imaging demonstrated stable constructs. There are many approaches to anterior cervical pathology at the craniocervical junction. Posterior instrumented reduction and stabilization of the occipitocervical spine can be safely achieved, obviating the need for a transoral approach in the setting of craniocervical junction settling.

Novel technique for preoperative pedicle localization in spinal surgery with challenging anatomy.

Accurately localizing a spine level in the thoracic spine is often not easily achieved with the existing imaging modalities available in the operating room. The coordination of the preoperative imaging pathology with intraoperative imaging is even more difficult in patients with challenging anatomy. Using standard percutaneous techniques, the authors placed a radiopaque embolization coil into the pedicle of interest under biplanar fluoroscopy in 1 patient. Thoracic spine MRI along with scout MRI was then performed to confirm coil marker placement in relation to the actual spine pathology prior to surgical intervention. No complications were observed during placement of the radiopaque marker. Intraoperatively, the marker was immediately and easily visualized, leading to a confident identification of the correct thoracic spinal level. The preoperative placement of a radiopaque marker into the vertebral pedicle of the identified pathological level combined with postplacement MRI verification provides an advantage over previously proposed techniques in the literature.

Immediate titanium mesh cranioplasty for treatment of postcraniotomy infections.

OBJECTIVE: Postcraniotomy infections have generally been treated by debridement of infected tissues, disposal of the bone flap, and delayed cranioplasty several months later to repair the resulting skull defect. Debridement followed by retention of the bone flap has also been advocated. Here we propose an alternative operative strategy for the treatment of postcraniotomy infections. METHODS: Two patients presenting with clinical and radiographic signs and symptoms of postcraniotomy infections were treated by debridement, bone flap disposal, and immediate titanium mesh cranioplasty. The patients were subsequently administered antibiotics, and their clinical courses were followed. RESULTS: The patients treated in this fashion did not have recurrence of their infections during 3-year follow-up periods. CONCLUSIONS: Surgical debridement, bone flap disposal, and immediate titanium mesh cranioplasty may be a suitable option for the treatment of postcraniotomy infections. This treatment strategy facilitates the eradication of infectious sources and obviates the risks and costs associated with a second surgical procedure.

The lateralization accuracy of inferior petrosal sinus sampling in 501 patients with Cushing's disease.

CONTEXT: It is often difficult to find an adenoma in patients with Cushing's disease (CD) whose preoperative magnetic resonance imaging (MRI) is normal. Better localizing modalities are needed. OBJECTIVE: The aim of this study was to determine the accuracy of inferior petrosal sinus sampling (IPSS) in predicting adenoma lateralization. DESIGN AND SETTING: We conducted a prospective observational study at a tertiary care clinical research center. PATIENTS: A total of 501 consecutive patients (363 female) with confirmed ACTH adenomas and IPSS were included. MAIN OUTCOME MEASURE: We measured the accuracy of IPSS to predict the intrasellar location of an adenoma. RESULTS: IPSS confirmed a pituitary source of ACTH secretion in 491 patients (98%). All 10 patients with false-negative results had peak IPSS ACTH concentrations (before or after CRH) of < 400 pg/ml. Interpetrosal (side-to-side) ratios were ≥ 1.4 in 491 patients (98%). This ratio correctly predicted lateralization in 273 of 396 patients (positive predictive value = 69%) with a lateral adenoma. Left-sided IPSS lateralization (P = .008) and consistent lateralization before and after CRH administration (P = .02) were associated with enhanced accuracy. When positive, preoperative MRI correlated with adenoma location in 171 of 201 patients (positive predictive value = 86%). CONCLUSIONS: Potential false-negative results, the most common type of diagnostic error with IPSS for the differential diagnosis of CS, can be identified by peak IPSS ACTH values < 400 pg/ml. When MRI is normal, IPSS can be used to guide surgical exploration in patients with negative preoperative imaging. However, because of the limited accuracy of lateralization, thorough exploration of the pituitary gland is required when an adenoma is not readily discovered based on predicted location.

Outcome of surgical treatment of 200 children with Cushing's disease.

CONTEXT: Factors influencing the outcome of surgical treatment of pediatric Cushing's disease (CD) have not been fully established. OBJECTIVE: The aim of this study was to examine features influencing the outcome of surgery for pediatric CD. DESIGN: In this prospective observational study, the clinical, imaging, endocrinological, and operative outcomes were analyzed in consecutive patients treated at the National Institutes of Health (NIH) from 1982 through 2010. SETTING: The study was conducted in a tertiary referral center. RESULTS: Two hundred CD patients (106 females, 94 males) were included. Mean age at symptom development was 10.6 ± 3.6 years (range, 4.0 to 19.0 y). Mean age at NIH operation was 13.7 ± 3.7 years. Twenty-seven patients (13%) had prior surgery at another institution. Magnetic resonance imaging identified adenomas in 97 patients (50%). When positive, magnetic resonance imaging accurately defined a discrete adenoma in 96 of the 97 patients (99%), which was more accurate than the use of ACTH ratios during inferior petrosal sinus sampling to determine adenoma lateralization (accurate in 72% of patients without prior surgery). A total of 195 of the 200 patients (98%) achieved remission after surgery (189 [97%] were hypocortisolemic; 6 [3%] were eucortisolemic postoperatively). Factors associated with initial remission (P < .05) included identification of an adenoma at surgery, immunohistochemical ACTH-producing adenoma, and noninvasive ACTH adenoma. Younger age, smaller adenoma, and absence of cavernous sinus wall or other dural invasion were associated with long-term remission (P < .05). A minimum morning serum cortisol of less than 1 µg/dl after surgery had a positive predictive value for lasting remission of 96%. CONCLUSIONS: With rare disorders, such as pediatric CD, enhanced outcomes are obtained by evaluation and treatment at centers with substantial experience. Resection of pituitary adenomas in pediatric CD in that setting can be safe, effective, and durable. Early postoperative endocrine testing predicts lasting remission. Because lasting remission is associated with younger age at surgery, smaller adenomas, and lack of dural invasion, early diagnosis should improve surgical outcome.

The role of adjuvant radiation therapy in the management of high-grade gliomas.

The purpose of this article is to update the neurosurgical community on the role of adjuvant radiation therapy in the management of patients with high-grade glioma. This information guides clinicians in the multidisciplinary management of these patients via a review of the literature describing current treatment paradigms as well as new avenues of investigation.