Lumbar Facet Arthroplasty Versus Fusion for Grade-I Degenerative Spondylolisthesis with Stenosis: A Prospective Randomized Controlled Trial.

BACKGROUND: The comparative effectiveness of decompression plus lumbar facet arthroplasty versus decompression plus instrumented lumbar spinal fusion in patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis is unknown. METHODS: In this randomized, controlled, Food and Drug Administration Investigational Device Exemption trial, we assigned patients who had single-level lumbar spinal stenosis and grade-I degenerative spondylolisthesis to undergo decompression plus lumbar facet arthroplasty (arthroplasty group) or decompression plus fusion (fusion group). The primary outcome was a predetermined composite clinical success score. Secondary outcomes included the Oswestry Disability Index (ODI), visual analog scale (VAS) back and leg pain, Zurich Claudication Questionnaire (ZCQ), Short Form (SF)-12, radiographic parameters, surgical variables, and complications. RESULTS: A total of 321 adult patients were randomized in a 2:1 fashion, with 219 patients assigned to undergo facet arthroplasty and 102 patients assigned to undergo fusion. Of these, 113 patients (51.6%) in the arthroplasty group and 47 (46.1%) in the fusion group who had either reached 24 months of postoperative follow-up or were deemed early clinical failures were included in the primary outcome analysis. The arthroplasty group had a higher proportion of patients who achieved composite clinical success than did the fusion group (73.5% versus 25.5%; p < 0.001), equating to a between-group difference of 47.9% (95% confidence interval, 33.0% to 62.8%). The arthroplasty group outperformed the fusion group in most patient-reported outcome measures (including the ODI, VAS back pain, and all ZCQ component scores) at 24 months postoperatively. There were no significant differences between groups in surgical variables or complications, except that the fusion group had a higher rate of developing symptomatic adjacent segment degeneration. CONCLUSIONS: Among patients with lumbar spinal stenosis and grade-I degenerative spondylolisthesis, lumbar facet arthroplasty was associated with a higher rate of composite clinical success than fusion was at 24 months postoperatively. LEVEL OF EVIDENCE: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

Sleep Disturbances in Cervical Spondylotic Myelopathy: Prevalence and Postoperative Outcomes-an Analysis From the Quality Outcomes Database.

STUDY DESIGN: Prospective observational study, level of evidence 1 for prognostic investigations. OBJECTIVES: To evaluate the prevalence of sleep impairment and predictors of improved sleep quality 24 months postoperatively in cervical spondylotic myelopathy (CSM) using the quality outcomes database. SUMMARY OF BACKGROUND DATA: Sleep disturbances are a common yet understudied symptom in CSM. MATERIALS AND METHODS: The quality outcomes database was queried for patients with CSM, and sleep quality was assessed through the neck disability index sleep component at baseline and 24 months postoperatively. Multivariable logistic regressions were performed to identify risk factors of failure to improve sleep impairment and symptoms causing lingering sleep dysfunction 24 months after surgery. RESULTS: Among 1135 patients with CSM, 904 (79.5%) had some degree of sleep dysfunction at baseline. At 24 months postoperatively, 72.8% of the patients with baseline sleep symptoms experienced improvement, with 42.5% reporting complete resolution. Patients who did not improve were more like to be smokers [adjusted odds ratio (aOR): 1.85], have osteoarthritis (aOR: 1.72), report baseline radicular paresthesia (aOR: 1.51), and have neck pain of ≥4/10 on a numeric rating scale. Patients with improved sleep noted higher satisfaction with surgery (88.8% vs 72.9%, aOR: 1.66) independent of improvement in other functional areas. In a multivariable analysis including pain scores and several myelopathy-related symptoms, lingering sleep dysfunction at 24 months was associated with neck pain (aOR: 1.47) and upper (aOR: 1.45) and lower (aOR: 1.52) extremity paresthesias. CONCLUSION: The majority of patients presenting with CSM have associated sleep disturbances. Most patients experience sustained improvement after surgery, with almost half reporting complete resolution. Smoking, osteoarthritis, radicular paresthesia, and neck pain ≥4/10 numeric rating scale score are baseline risk factors of failure to improve sleep dysfunction. Improvement in sleep symptoms is a major driver of patient-reported satisfaction. Incomplete resolution of sleep impairment is likely due to neck pain and extremity paresthesia.

Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis.

OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy of a posterior facet replacement device, the Total Posterior Spine (TOPS) System, for the treatment of one-level symptomatic lumbar stenosis with grade I degenerative spondylolisthesis. Posterior lumbar arthroplasty with facet replacement is a motion-preserving alternative to lumbar decompression and fusion. The authors report the preliminary results from the TOPS FDA investigational device exemption (IDE) trial. METHODS: The study was a prospective, randomized controlled FDA IDE trial comparing the investigational TOPS device with transforaminal lumbar interbody fusion (TLIF) and pedicle screw fixation. The minimum follow-up duration was 24 months. Validated patient-reported outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) for back and leg pain. The primary outcome was a composite measure of clinical success: 1) no reoperations, 2) no device breakage, 3) ODI reduction of ≥ 15 points, and 4) no new or worsening neurological deficit. Patients were considered a clinical success only if they met all four measures. Radiographic assessments were made by an independent core laboratory. RESULTS: A total of 249 patients were evaluated (n = 170 in the TOPS group and n = 79 in the TLIF group). There were no statistically significant differences between implanted levels (L4-5: TOPS, 95% and TLIF, 95%) or blood loss. The overall composite measure for clinical success was statistically significantly higher in the TOPS group (85%) compared with the TLIF group (64%) (p = 0.0138). The percentage of patients reporting a minimum 15-point improvement in ODI showed a statistically significant difference (p = 0.037) favoring TOPS (93%) over TLIF (81%). There was no statistically significant difference between groups in the percentage of patients reporting a minimum 20-point improvement on VAS back pain (TOPS, 87%; TLIF, 64%) and leg pain (TOPS, 90%; TLIF, 88%) scores. The rate of surgical reintervention for facet replacement in the TOPS group (5.9%) was lower than the TLIF group (8.8%). The TOPS cohort demonstrated maintenance of flexion/extension range of motion from preoperatively (3.85°) to 24 months (3.86°). CONCLUSIONS: This study demonstrates that posterior lumbar decompression and dynamic stabilization with the TOPS device is safe and efficacious in the treatment of lumbar stenosis with degenerative spondylolisthesis. Additionally, decompression and dynamic stabilization with the TOPS device maintains segmental motion.

Minimally Invasive Surgical Approach for Odontoid Lesions: A Technical Description in a Case of High Cervical Osteomyelitis and Abscess.

BACKGROUND: Cervical approaches to the dens are limited by the presence of several structures, including the spinal cord, vertebral arteries, C1 articular pillars, and C2 nerves. Surgical approaches to access the high anterior cervical spine classically encompass the extended anterior retropharyngeal route, transoral route, and extreme lateral route, each of which has its own pattern of morbidity or complications. Percutaneous procedures to drain infections in this area have a limited yield. Osteomyelitis of the dens is a rare but serious condition that is associated with significant mortality. Patients with cervical osteomyelitis and epidural abscess are likely to have significant coexistent medical comorbidities and are often poor candidates for extensive surgical procedures. A minimally invasive approach that gives access to the entire odontoid process would allow for more aggressive treatments and potentially even a complete odontoidectomy without resection of the C1 anterior arch. CASE DESCRIPTION: We describe a minimally invasive approach to drainage and debridement of an atlantoaxial epidural abscess and osteomyelitis. Using minimally invasive techniques from a posterolateral trajectory in a cadaveric specimen, we were able to safely access the anterior epidural space, odontoid, and retropharynx. We then performed this approach in our patient who was unable to tolerate a large surgical procedure. CONCLUSIONS: We developed, tested, and then applied a minimally invasive approach that combined tubular retractors with positioning of the head and neck to optimize the exposure in a patient with a complex abscess that involved the ventral epidural space, odontoid process, and retropharyngeal space. The abscesses were successfully drained along with local tissue debridement without complication. A posterolateral minimally invasive approach is a safe alternative in patients with an atlantoaxial epidural abscess, odontoid osteomyelitis, or retropharyngeal abscess with significant medical comorbidities who are unlikely to tolerate a more extensive surgery. It can also be used for resections of lesions of an oncologic nature and could even be used to resect pannus or os odontoideum, without necessitating an anterior approach or resection even of the C1 arch.

Arachnoiditis ossificans.

OBJECTIVE: Arachnoiditis ossificans is an uncommon clinical entity in which arachnoid ossification leads to clinical symptomatology. In this case report, we describe the case of a myelopathic patient with arachnoid ossifications, an arachnoid cyst, and syringomyelia coexisting with a herniated thoracic disc at the same levels. CASE DESCRIPTION: An 81-year-old woman presented with rapidly progressive leg weakness, dysesthetic pains, and urinary incontinence. RESULTS: The patient underwent thoracic laminectomy with costotransversectomy for resection of ossified arachnoid and re-establishment of cerebrospinal fluid pathways. CONCLUSION: Altered cerebrospinal fluid dynamics secondary to the obstruction in subarachnoid flow may predispose to the formation of an arachnoid cyst, and the cyst itself may be the proximate cause of the myelopathy.

Laminoplasty outcomes: is there a difference between patients with degenerative stenosis and those with ossification of the posterior longitudinal ligament?

OBJECT: Two common causes of cervical myelopathy include degenerative stenosis and ossification of the posterior longitudinal ligament (OPLL). It has been postulated that patients with OPLL have more complications and worse outcomes than those with degenerative stenosis. The authors sought to compare the surgical results of laminoplasty in the treatment of cervical stenosis with myelopathy due to either degenerative changes or segmental OPLL. METHODS: The authors conducted a retrospective review of 40 instrumented laminoplasty cases performed at a single institution over a 4-year period to treat cervical myelopathy without kyphosis. Twelve of these patients had degenerative cervical stenotic myelopathy ([CSM]; degenerative group), and the remaining 28 had segmental OPLL (OPLL group). The 2 groups had statistically similar demographic characteristics and number of treated levels (mean 3.9 surgically treated levels; p > 0.05). The authors collected perioperative and follow-up data, including radiographic results. RESULTS: The overall clinical follow-up rate was 88%, and the mean clinical follow-up duration was 16.4 months. The mean radiographic follow-up rate was 83%, and the mean length of radiographic follow-up was 9.3 months. There were no significant differences in the estimated blood loss (EBL) or length of hospital stay (LOS) between the groups (p > 0.05). The mean EBL and LOS for the degenerative group were 206 ml and 3.7 days, respectively. The mean EBL and LOS for the OPLL group were 155 ml and 4 days, respectively. There was a statistically significant improvement of more than one grade in the Nurick score for both groups following surgery (p < 0.05). The Nurick score improvement was not statistically different between the groups (p > 0.05). The visual analog scale (VAS) neck pain scores were similar between groups pre- and postoperatively (p > 0.05). The complication rates were not statistically different between groups either (p > 0.05). Radiographically, both groups lost extension range of motion (ROM) following laminoplasty, but this change was not statistically significant (p > 0.05). CONCLUSIONS: Patients with CSM due to either degenerative disease or segmental OPLL have similar perioperative results and neurological outcomes with laminoplasty. The VAS neck pain scores did not improve significantly with laminoplasty for either group. Laminoplasty may limit extension ROM.

Outcomes of carotid artery stenting in high-risk patients with carotid artery stenosis: a single neurovascular center retrospective review of 101 consecutive patients.

OBJECTIVE: Carotid artery angioplasty and carotid artery stenting (CAS) offer a viable alternative to carotid endarterectomy for symptomatic and asymptomatic patients; however, the complication rates associated with CAS may be higher than previously documented. We evaluated the safety and efficacy of CAS in high surgical risk patients in a single neurovascular center retrospective review. METHODS: An institutional review board-approved retrospective review of the clinical variables and treatment outcomes of 101 consecutive patients (109 stents) from July 2001 to March 2007 with carotid stenosis were analyzed. Both symptomatic and asymptomatic stenoses were studied in high surgical risk patients as defined by the SAPPHIRE (Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy) trial. Specifically, those patients with clinically significant cardiac disease (congestive heart failure, abnormal stress test, or need for open-heart surgery), severe pulmonary disease, contralateral carotid occlusion, contralateral laryngeal nerve palsy, recurrent stenosis after carotid endarterectomy, previous radical neck surgery, or radiation therapy to the neck, and an age older than 80. RESULTS: Seventy-four percent of the patients were symptomatic (n = 81), and the mean stenosis in symptomatic patients was 83%. Reasons for stenting included cardiac/pulmonary/medical risk (60%), contralateral internal carotid artery occlusion (8%), recurrent stenosis after carotid endarterectomy (11%), carotid dissection (6%), age older than 80 (7%), previous radical neck surgery (7%), and previous neck radiation (1%). Stent deployment was achieved in 108 of 109 vessels (99%). Distal embolic protection devices were used in 72% of cases treated. The overall rate of in-hospital adverse events (transient ischemic attack, intracranial hemorrhage, minor stroke, major stroke, myocardial infarction, and death) was 8.3% (9 of 109). Of these events, 2 patients (1.8%) experienced a hemispheric transient ischemic attack (neurological symptoms that resolved within 24 hours), 2 others (1.8%) had transiently symptomatic acute reperfusion syndrome. The 30-day stroke/death/myocardial infarction risk was 4.6% (n = 5). Of these patients, 3 had minor strokes (2.7%) defined as a modified Rankin Scale score less than 3 at 1-year follow-up, 1 had a major stroke (0.9%) defined as a modified Rankin Scale score of 3 or more at 1-year follow-up, and 1 patient died after a periprocedural myocardial infarction (0.9%). CONCLUSION: CAS can be performed with a low 30-day complication rate, even with a higher percentage of symptomatic lesions. The results support the use of CAS in high surgical risk patients with both significant symptomatic and asymptomatic carotid artery disease.

Surgical treatment of metastatic spinal tumors.

Spinal metastases represent a significant cause of morbidity in patients diagnosed with malignancies. Metastases to the spine can cause severe pain, paralysis, and impairment of activities of daily living. The treatment paradigm for spinal metastases involves a cohesive multidisciplinary approach that allows treatment plans to be made in the context of a patient's overall condition. There have been significant advances in the surgical treatment of spinal metastases that can significantly improve a patient's quality of life.

Relationship between photoreceptor outer segment length and visual acuity in diabetic macular edema.

PURPOSE: The purpose of this study was to quantify photoreceptor outer segment (PROS) length in 27 consecutive patients (30 eyes) with diabetic macular edema using spectral domain optical coherence tomography and to describe the correlation between PROS length and visual acuity. METHODS: Three spectral domain-optical coherence tomography scans were performed on all eyes during each session using Cirrus HD-OCT. A prototype algorithm was developed for quantitative assessment of PROS length. Retinal thicknesses and PROS lengths were calculated for 3 parameters: macular grid (6 x 6 mm), central subfield (1 mm), and center foveal point (0.33 mm). Intrasession repeatability was assessed using coefficient of variation and intraclass correlation coefficient. The association between retinal thickness and PROS length with visual acuity was assessed using linear regression and Pearson correlation analyses. The main outcome measures include intrasession repeatability of macular parameters and correlation of these parameters with visual acuity. RESULTS: Mean retinal thickness and PROS length were 298 mum to 381 microm and 30 microm to 32 mum, respectively, for macular parameters assessed in this study. Coefficient of variation values were 0.75% to 4.13% for retinal thickness and 1.97% to 14.01% for PROS length. Intraclass correlation coefficient values were 0.96 to 0.99 and 0.73 to 0.98 for retinal thickness and PROS length, respectively. Slopes from linear regression analyses assessing the association of retinal thickness and visual acuity were not significantly different from 0 (P > 0.20), whereas the slopes of PROS length and visual acuity were significantly different from 0 (P < 0.0005). Correlation coefficients for macular thickness and visual acuity ranged from 0.13 to 0.22, whereas coefficients for PROS length and visual acuity ranged from -0.61 to -0.81. CONCLUSION: Photoreceptor outer segment length can be quantitatively assessed using Cirrus HD-OCT. Although the intrasession repeatability of PROS measurements was less than that of macular thickness measurements, the stronger correlation of PROS length with visual acuity suggests that the PROS measures may be more directly related to visual function. Photoreceptor outer segment length may be a useful physiologic outcome measure, both clinically and as a direct assessment of treatment effects.

Novel fluoroscopic technique for localization at cervicothoracic levels.

STUDY DESIGN: To use a novel modified intraoperative fluoroscopic view for spinal level localization. OBJECTIVE: To evaluate the safety and utility of the modified oblique fluoroscopic technique for intraoperative localization of distal cervical and proximal thoracic spinal levels. SUMMARY OF BACKGROUND INFORMATION: Operative radiographic localization of the cervicothoracic spine using standard anterior-posterior and lateral views is made difficult by its anatomic relationship to the shoulder and upper chest, which produce radiographic shadowing obscuring the spine. Additional image degradation can be caused by muscular patients or those with a high body mass index. An oblique modification of the standard cross table lateral can be used to accurately identify pathologic levels at or across the cervicothoracic junction. This method distinctly demonstrates the bony lamina, which can then be used to count spinal levels. The unique feature of this technique is that the oblique angle removes the shoulder and the majority of the ribs from the active field of view, thereby producing a cleaner and more distinct image. When the gantry angle of the fluoroscope is parallel to the plane of the opposite lamina, it gives a type of "target sign" similar to the trans-pedicular image commonly used in pedicle screw placement. This radiographic sign can be easily identified and recognized across the cervicothoracic junction, even in those patients with a large body mass index or large musculature. METHODS: Spinal level was determined intraoperatively through our oblique technique and confirmed in the same patient through standard views with retrograde counting. Postoperative imaging confirmed correct level surgery. RESULTS: Correct spinal level identification was achieved in the distal cervical and proximal thoracic spine by implementation of our novel oblique fluoroscopy technique. CONCLUSIONS: The modified oblique cross table fluoroscopy technique allows accurate operative localization across the cervicothoracic junction and well into the thoracic spine.

Treatment of primary vertebral tumors.

Advances in the treatment of disease and detection through advanced imaging have led to an increase in the discovery of vertebral tumors. Although the majority of symptomatic spinal lesions are metastatic in origin, a significant number of them arise primarily in the spine. These lesions encompass a wide variety of tumor types classified by their cell of origin: bony tumors, cartilaginous tumors, vascular tumors, plasma cell dyscrasias, and tumors that arise from embryonic rests. Further classification of these tumors into malignant or benign subtypes is based on their clinical progression, histopathological evidence of invasiveness, and response to therapy. We provide a brief overview and description of primary tumors as well as treatment paradigms for the individual tumor types. Mt Sinai J Med 76:499-504, 2009. (c) 2009 Mount Sinai School of Medicine.

Novel surgical treatment of a transverse-sigmoid sinus aneurysm presenting as pulsatile tinnitus: technical case report.

OBJECTIVE: Pulsatile tinnitus is a relatively common, potentially incapacitating condition that is often vascular in origin. We present a case of disabling pulsatile tinnitus caused by a transverse-sigmoid sinus aneurysm that was surgically treated with self-tying U-clips (Medtronic, Inc., Memphis, TN). We also review the literature and discuss other described interventions. CLINICAL PRESENTATION: A 48-year-old woman presented with a 5-year history of progressive pulsatile tinnitus involving the right ear. Her physical examination was consistent with a lesion that was venous in origin. Angiography demonstrated a wide-necked venous aneurysm of the transverse-sigmoid sinus that had eroded the mastoid bone. INTERVENTION: The patient underwent a retromastoid suboccipital craniectomy to expose the aneurysm and surrounding anatomy. The aneurysm dome was tamponaded and the aneurysm neck was coagulated until the dome had shrunk to a small remnant. The linear defect in the transverse sigmoid junction was then reconstructed with a series of U-clips and covered with Gelfoam hemostatic sponge (Pfizer, Inc., New York, NY). The patient awakened without neurological deficit and with immediate resolution of her tinnitus. A postoperative angiogram demonstrated obliteration of the aneurysm, with minimal stenosis in the region of the repair and good flow through the dominant right transverse-sigmoid junction. CONCLUSION: This technical case report describes a novel definitive surgical treatment of venous sinus aneurysms. This technique does not necessitate long-term anticoagulation, has a low likelihood of reintervention, and provides immediate resolution of pulsatile tinnitus.