Failure rates and complications of interspinous process decompression devices: a European multicenter study.

OBJECT Spacers placed between the lumbar spinous processes represent a promising surgical treatment alternative for a variety of spinal pathologies. They provide an unloading distractive force to the stenotic motion segment, restoring foraminal height, and have the potential to relieve symptoms of degenerative disc disease. The authors performed a retrospective, multicenter nonrandomized study consisting of 1108 patients to evaluate implant survival and failure modes after the implantation of 8 different interspinous process devices (IPDs). METHODS The medical records of patients who had undergone placement of an IPD were retrospectively evaluated, and demographic information, diagnosis, and preoperative pain levels were recorded. Preoperative and postoperative clinical assessments in the patients were based on the visual analog scale. A minimum of 3 years after IPD placement, information on long-term outcomes was obtained from additional follow-up or from patient medical and radiological records. RESULTS One thousand one hundred eight patients affected by symptomatic 1- or 2-level segmental lumbar spine degenerative disease underwent placement of an IPD. The complication rate was 7.8%. There were 27 fractures of the spinous process and 23 dura mater tears with CSF leakage. The ultimate failure rate requiring additional surgery was 9.6%. The reasons for revision, which always involved removal of the original implant, were acute worsening of low-back pain or lack of improvement (45 cases), recurrence of symptoms after an initial good outcome (42 cases), and implant dislocation (20 cases). CONCLUSIONS The IPD is not a substitute for a more invasive 3-column fusion procedure in cases of major instability and spondylolisthesis. Overdistraction, poor bone density, and poor patient selection may all be factors in the development of complications. Preoperatively, careful attention should be paid to bone density, appropriate implant size, and optimal patient selection.

Role of EVICEL Fibrin Sealant to Assist Hemostasis in Cranial and Spinal Epidural Space: A Neurosurgical Clinical Study.

A variety of techniques have been used to stop venous bleeding from the cranial and spinal epidural space. These generally consist of packing with oxidized regenerated cellulose, fibrillar collagen, and so forth, and in cranial surgery, tack-up sutures. Bipolar coagulation may also be used to control bleeding from spinal venous plexus, but it may bear the risk of healthy nervous tissue injury: dissipation of heat from the tips of the bipolar forceps may induce thermal injury to adjacent neural structures. Quick and safe hemostasis reduces the duration of surgery. Efficient control of bleeding is also a prerequisite for the realization of the planned therapeutic procedure, that is, the result of surgery, and can thereby reduce perioperative morbidity. Fibrin sealant is safely used to increase hemostasis and to treat cerebrospinal leakage. Between January 2014 and March 2015, the authors used injection of fibrin sealant (EVICEL®, Johnson & Johnson Wound Management, Somerville, NJ) into the cranial and spinal epidural space to assist in hemostasis in 97 patients. EVICEL injection was used in 81 cases of cranial surgery and 16 cases of spinal surgery. When the venous bleeding continued from the epidural space after packing with classical hemostatic agents, fibrin sealant was used to stop venous bleeding. When arterial bleeding was present, fibrin sealant was not used. In all cases, the results were judged to be excellent with stoppage of epidural bleeding, or good with mild persistent oozing. During the 10-minute observation period, no patients treated with EVICEL required additional hemostatic measures. No complications related to the fibrin glue were encountered.

(EVICEL) for Augmentation of Dural Closure: Results of a Preliminary Clinical Study.

The authors prospectively evaluated the safety and efficacy of a new fibrin sealant in patients undergoing emergency and elective cranial/spinal surgery with documented cerebrospinal fluid (CSF) leakage after sutured dural repair. This study was designed as a prospective, nonrandomized clinical trial. EVICEL® Fibrin Sealant (Johnson & Johnson, Somerville, NJ) was used in 72 patients with documented intraoperative CSF leakage after neurosurgical dural repair for a variety of pathologies. Intraoperative CSF leakage was either spontaneous or induced by a Valsalva maneuver. Patients were monitored for 1 month postoperatively with physical examinations, clinical laboratory analyses, and diagnostic imaging (CT or MRI). The sealant was effective in closing intraoperative CSF leakage in all patients but one. There were no sealant-related adverse events, and all clinical outcomes were consistent with expectations for seriously ill patients undergoing prolonged neurosurgical procedures. EVICEL® Fibrin Sealant provides a safe and effective watertight closure when used as an adjunct to sutured dural repair during cranial surgery.

Safety of intraoperative electrophysiological monitoring (TES and EMG) for spinal and cranial lesions.

Intraoperative motor evoked potentials (MEP) and electromyography (EMG) monitoring in patients with spinal and cranial lesions is a valuable tool for prevention of postoperative motor deficits. The purpose of this study was to determine whether electrophysiological monitoring during skull base, spinal cord, and spinal surgery might be useful for predicting postoperative motor deterioration. From January 2012 to March 2013, thirty-three consecutive patients were studied using intraoperative monitoring (Nuvasive NV-M5 System) to check the integrity of brainstem, spinal cord, and nerve roots, recording transcranial motor evoked potentials (TcMEPs) and electromyography. Changes in MEPs and EMGs were related to postoperative deficits. Preoperative diagnosis included skull base and brainstem lesions (6 patients), spinal tumors (11 patients), spinal deformity (16 cases). Using TcMEPs and EMG is a practicable and safe method. MEPs are useful in any surgery in which the brainstem and spinal cord are at risk. EMG stimulation helps to identify an optimal trans-psoas entry point for an extreme lateral lumbar interbody fusion (XLIF) approach to protect against potential nerve injury. This neural navigation technique via a surgeon-interpreted interface assists the surgical team in safely removing lesions and accessing the intervertebral disc space for minimally invasive spinal procedures.

Litanium expandable pedicle screw for the treatment of degenerative and traumatic spinal diseases in osteoporotic patients: preliminary experience.

Osteoporosis is a major global health problem, with over 10 million people currently diagnosed with the disease. Although 80% of osteoporotic patients are women, a considerable number of men are also affected. Also, due to increasing life expectancy, the number of elderly patients with osteoporosis affected by degenerative and traumatic spinal diseases will increase further. Osteoporosis reduces bone quality through negative bone remodelling. Low bone quality can reduce the pull-out strength of pedicle screw, and negative bone remodelling can cause delayed bone fusion. However, pedicle screw instrumentation of the osteoporotic spine carries an increased risk of screw loosening, pull-out, and fixation failure. Our preliminary study aims to investigate the efficiency of expandable pedicle screws (OsseoScrew-Spinal Fixation System, Alphatec Spine Inc., Carlsbad, CA) in osteoporotic spinal patients. All osteoporotic patients with degenerative and traumatic spinal diseases admitted in our department underwent a pre-operative spinal x-Ray and MRI or CT. Pre-operative clinical assesment of patients was based on the visual analog scale (VAS) and Owestry Disability (ODI) questionnaire-a disease-specific outcome measure. Ten osteoporotic patients were treated with expandable pedicle screws (OsseoScrew). Post-operative clinical assessment of patients was based on the VAS and ODI questionnaire at 3 months and 1 year of follow-up. Post-operative radiologic follow-up was performed after 3 days (CT, x-ray); 3 months (x-ray); 6 months (spinal CT); and 1 year (spinal CT). Expandable pedicle screws improved pull-out strength as compared to standard pedicle screws in osteoporotic patients with degenerative and traumatic spinal diseases.

Surgical treatment of degenerative and traumatic spinal diseases with expandable screws in patients with osteoporosis: 2-year follow-up clinical study.

OBJECTIVE Pedicle screw instrumentation of the osteoporotic spine carries an increased risk of screw loosening, pullout, and fixation failure. A variety of techniques have been used clinically to improve pedicle screw fixation in the presence of compromised bone. Pedicle screws may be augmented with cement, but this may lead to cement leakage and result in disastrous consequences. To avoid these complications, a multiaxial expandable pedicle screw has been developed. This was a prospective, single-center study designed to evaluate the clinical results of patients with osteoporosis with traumatic and degenerative spinal diseases treated with expandable pedicle screws. METHODS Thirty-three patients (mean age 61.4 years) with osteoporosis and traumatic or degenerative spinal diseases underwent spinal posterior fixation with expandable screws. Preoperative and postoperative visual analog scale (VAS) for pain and Oswestry Disability Index (ODI) questionnaire scores were obtained. The immediate postoperative screw position was measured and compared with the final position on lateral plain radiographs and axial CT scans at the 1- and 2-year follow-up examinations. RESULTS A total of 182 pedicle screws were used, including 174 expandable and 8 regular screws. The mean preoperative patient VAS score improved from 8.2 to 3.6 after surgery. The mean ODI score improved from 83.7% before surgery to 29.7% after the operation and to 36.1% at the final follow-up. No screw migration had occurred at the 1-year follow-up, but 1 screw breakage/migration was visualized on spinal radiography at the 2-year follow-up. CONCLUSIONS The results of this study show that the multiaxial expandable pedicle screw is a safe and practical technique for patients with osteoporosis and various spinal diseases and adds a valuable tool to the armamentarium of spinal instrumentation.

Use of tissue-glue-coated collagen sponge (TachoSil) to repair minor cerebral dural venous sinus lacerations: technical note.

BACKGROUND: Significant hemorrhage may occur from the cerebral venous sinuses during the dural separation from the bone flap, particularly in elderly patients. It is important to achieve an urgent hemostatic control. OBJECTIVE: To evaluate the efficacy and safety of a new fixed combination tissue sealant (TachoSil) in patients with bleeding from lacerations of cerebral venous sinuses. METHODS: Between September 2012 and June 2014, 57 patients (39 female, 18 male) presenting with iatrogenic tears of the superior sagittal or transverse/sigmoid sinuses were treated with a topical fibrin sealant patch. Intraoperative source of bleeding, time to bleeding control, quantity of sealant sponge used, and postoperative complications were evaluated. Time to hemostasis was used as the primary end point. RESULTS: Effective hemostasis, defined as cessation of bleeding after application of topical hemostatic agent, was achieved no later than 4 minutes in all except 5 patients with persistent bleeding from the sinus. In these 5 cases, bleeding was finally stopped after application of a new larger layer of TachoSil Sponge (2 cases) or gelatin hemostatic matrix (2 cases) or fibrin glue (1 case) over the layer of TachoSil. CONCLUSION: We report our experience with a new hemostasis technique to manage bleeding from iatrogenic lacerations of cerebral venous sinuses.

Anterior expandable cylindrical cage reconstruction after cervical spinal metastasis resection.

Surgical therapy of cervical spine metastases had evolved a in the last years from posterior decompressive approaches to a direct anterior reconstructive approaches. Indication for surgery included intractable neck pain, spinal cord compression and stabilization of impending pathological fractures. We report our experience with expandable cylindrical cages in order to reconstruct and to stabilize cervical spine with metastasis. Between June 2004 and January 2006, a consecutive series of six patients underwent to resection of metastatic tumor in the cervical spine followed by expandable cylindrical cage reconstruction of the anterior vertebral column. All patients achieved immediate stability with neurological preservation. There were no significant complications related to the expandable cages in a mean follow up period of 10.5 months. Expandable cylindrical cages are effective resources for functional reconstruction after tumor resection in patients with cervical metastasis with advantages in the quality of life.

Acute hemorrhagic cyst of the ligamentum flavum.

STUDY DESIGN: A case report and clinical discussion. OBJECTIVE: To describe a rare complication of a cyst of the ligamentum flavum, which bled spontaneously, provoking an acute lower limb monoparesis and lumbar sciatic pain. SUMMARY OF BACKGROUNDS DATA: Cysts of the ligamentum flavum have been rarely reported. Intraspinal degenerative cysts described in literature are usually juxta-articular (synovial and ganglion) cysts and have a similar radiologic appearance. They are preferentially located in the lumbar spine, while the cervical localization is unusual. Hemorrhage into the cyst is an uncommon complication and an extremely rare cause of nerve root compression. METHODS: A 59-year-old woman presented with sudden severe radicular lumbar deficit and pain secondary to acute hemorrhage into a ligamentum flavum cyst. Magnetic resonance imaging showed at L3-L4 level a lobulated slightly hyperintense mass with a ventral area of marked hyperintensity in T1 images, hypointense on T2 images. Signal within the lesion was suggestive of intralesional hemorrhage. RESULTS: Complete resection of the lesion was performed, resulting in immediate recovery. The cyst was quite rounded, brownish, and contained rest of both partially fresh and coagulated hematoma. Histologic examination revealed myxoid degeneration of the ligamentum flavum with an hemorrage in the cystic cavity without a synovial layer. CONCLUSIONS: This report identifies a rare case of radicular lumbar deficit and pain secondary to acute hemorrhage into a ligamentum flavum cyst. The pathogenesis and clinicopathologic characteristics of this lesion are described.