A prospective multicenter randomized study comparing the SpineJack system and nonsurgical management with a brace in acute traumatic vertebral fractures: the SPICO study.

OBJECTIVE: The objective of this study was to evaluate the efffectiveness of a titanium vertebral augmentation device (SpineJack system) in terms of back pain, radiological outcomes, and economic burden compared with nonsurgical management (NSM) (bracing) for the treatment of vertebral compression fractures. Complications were also evaluated for both treatment methods. METHODS: A prospective multicenter randomized study was performed at 9 French sites. Patients (n = 100) with acute traumatic Magerl type A1 and A3.1 vertebral fractures were enrolled and randomized to treatment with the SpineJack system or NSM consisting of bracing and administration of pain medication. Participants were monitored at admission, during the procedure, and at 1, 12, and 24 months after treatment initiation. Primary outcomes included visual analog scale back pain score, and secondary outcomes included disability (Oswestry Disability Index [ODI] score), health-related quality of life (EQ-5D score), radiological measures (vertebral kyphosis angle [VKA] and regional traumatic angulation [RTA]), and economic outcomes (costs, procedures, hours of help, and time to return to work). RESULTS: Ninety-five patients were included in the analysis, with 48 in the SpineJack group and 47 in the NSM group. Back pain improved significantly for all participants with no significant differences between groups. ODI and EQ-5D scores improved significantly between baseline and follow-up (1, 12, and 24 months) for all participants, with the SpineJack group showing a larger improvement than the NSM group between baseline and 1 month. VKA was significantly lower (p < 0.001) (i.e., better) in the SpineJack group than in the NSM group at 1, 12, and 24 months of follow-up. There was no significant change over time in RTA for the SpineJack group, but the NSM group showed a significant worsening in RTA over time. SpineJack treatment was associated with higher costs than NSM but involved a shorter hospital stay, fewer medical visits, and fewer hours of nursing care. Time to return to work was significantly shorter for the SpineJack group than for the NSM group. There were no significant differences in complications between the two treatments. CONCLUSIONS: Overall, there was no statistical difference in the primary outcomes between the SpineJack treatment group and the NSM group. In terms of secondary outcomes, SpineJack treatment was associated with better radiological outcomes, shorter hospital stays, faster return to work, and fewer hours of nursing care.

A Penetrating Lumbar Spine Injury With Misleading Neurological Symptoms.

Penetrating spinal injuries require specific neurosurgical attention. To date, there are no guidelines regarding emergency neurosurgical management of such injuries and the decision whether to operate is made individually, based on the neurological examination and the analysis of any imaging available. We report the case of a 22-year-old patient who sustained two gunshots in the thighs and one in the lumbar spine. Clinical examination revealed neurological deficit in both legs prevailing on the right side. Discussion between the radiologist and the neurosurgeon concluded to an injury to the left S1 nerve root within the spinal canal, and to the right sciatic nerve. Thus, there was no need for a decompressive laminectomy. In the light of the current literature, penetrating spinal injuries rarely require an extensive surgical exploration; indications for such a procedure include incomplete neurological deficit with persistent neurological compression, cerebrospinal fluid leakage, and obvious instability. Furthermore, penetrating spinal injuries are rarely encountered, even for military neurosurgeons. Their surgical management and especially the need for laminectomy, stabilization, and dural sac watertight closure are still a matter of debate. An expert consensus statement would give food to surgeons facing penetrating spinal injuries.

Delayed Collet-Sicard syndrome after internal carotid dissection and Jefferson fracture. Case report and Review of Literature.

BACKGROUND: Lower cranial nerve palsies, or Collet-Sicard syndrome, can be caused by many different etiologies including head trauma, basilar occipital fractures, tumors, and interventions. Few reports describe different presentations of this condition, and we present here a case study to increase awareness of and add to the variable spectrum. CASE DESCRIPTION: A 56-year-old who had been hit while diving was admitted to our department. On examination, he was conscious without any signs of lateralization but presented with severe neck pain. CT brain and cervical spine revealed a C1 fracture with bilateral symmetrical fracture of the anterior and posterior arches (Jefferson's fracture) and slight bilateral joint dislocation C1-C2 discreetly predominant on the left. One week later, he presented with dysarthria, dysphonia, swallowing disorder, anisocoria, tongue deviation, and palate deviation (XII, IX, and X). CT Angiography showed dissection of the internal carotid artery immediately after the carotid bulb. He has been treated conservatively with curative anticoagulants with stable symptoms. No surgical intervention had been proposed. CONCLUSION: Adding to the literature, delayed Collet-Sicard syndrome and lower cranial affection can be caused by missed carotid wall hematoma following severe craniocervical trauma associated with Jefferson's fracture.

[Percutaneous kyphoplasty using expandable SpineJack® implant for the treatment of osteoporotic vertebral fractures]. / Traitement de la fracture vertébrale ostéoporotique par kyphoplastie percutanée avec un extenseur de type SpineJack®.

ABSTRACT: The purpose of this study was to assess the outcome of surgical management of osteoporotic vertebral fractures with percutaneous kyphoplasty using expandible SpineJack® implant. METHODS: We conducted an analytical retrospective single-center study over a period of 33-months (April 2015 - December 2017). It involved patients treated with kyphoplasty for an osteoporotic vertebral fracture. The kit consisted of a Vexim SpineJack® expandable titanium implant and acrylic cement. Patients with back pain increasing in intensity despite treatment for an osteoporotic vertebral fracture were included in the study as well as those who had undergone surgery and had given their informed consent. The vertebral fracture was diagnosed based on CT scan results and its recent state was confirmed by MRI. RESULTS: Between april 2015 and december 2017, thirty-seven patients with osteoporotic vertebral fractures were treated with kyphoplasty using expandable titanium vertebral implant. The average age of patients was 73.4 years, with a sex ratio of 0.6. Mean visual analog scale score was 7.3. Mean Oswestry score was 81.6. The patients mainly had fractures of the thoracolumbar hinge. Mean vertebral kyphotic angle was 18.45°. Kyphoplasty was used for the treatment of 44 vertebrae. Four patients had surgical complications. The average length of stay in hospital was 5.4 days. After a follow-up period of 6 months, 9 patients were still receiving analgesic therapy. After one year, no adjacent level fracture was found. CONCLUSION: Percutaneous kyphoplasty using expandible titanium implant is a safe and effective therapeutic mean for osteoporotic vertebral fractures. Given its almost immediate result, patients can rapidly get back to their active lives.

A prospective, international, randomized, noninferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study).

BACKGROUND CONTEXT: Balloon kyphoplasty (BKP) is a commonly performed vertebral augmentation procedure for painful osteoporotic vertebral compression fractures (OVCFs). OBJECTIVE: This study aimed to support a non-inferiority finding for the use of a titanium implantable vertebral augmentation device (TIVAD) compared to BKP. STUDY DESIGN: Prospective, parallel group, controlled comparative randomized study. PATIENT SAMPLE: Patients who presented with one or two painful OVCFs located between T7 and L4 aged <3 months, failed conservative treatment, and had an Oswestry Disability Index (ODI) score ≥30/100 were eligible for the study. OUTCOME MEASURES: The primary composite endpoint was defined as: reduction in VCF fracture-related pain at 12 months from baseline and maintenance or functional improvement (ODI) at 12 months from baseline, and absence of device-related adverse event or surgical reintervention. If the primary composite endpoint was successful, a fourth component (absence of adjacent level fracture) was added for analysis. If the analysis of this additional composite endpoint was successful, then midline target height restoration at 6 and 12 months was assessed. Secondary clinical outcomes included back pain intensity, ODI score, EQ-5D index score (range 0=death to 1=full health) and EQ-VAS score (range 0-100). METHODS: Patients were recruited in 13 hospitals across 5 countries and were randomly assigned (1:1) to either TIVAD or BKP with electronic randomization as described in the protocol. A total of 152 patients with OVCFs were initially randomized. Eleven patients were excluded (six met exclusion criteria, one with evidence of tumor, and four patients had T score out of requested range). Anterior vertebral body height ratio, midline vertebral body height ratio, and Cobb angle were measured preoperatively and postoperatively by an independent imaging core lab. Adjacent and subsequent fractures and safety parameters were recorded throughout the study. Cement extravasation was evaluated on X-rays. All patients were followed at screening at 5 days, 1 month, 6 months, and 12 months postoperatively. This study was supported by Vexim SA. Seven authors received study-specific support less than $10,000 per year and seven authors received no study-specific support. RESULTS: Among the 141 patients (78.7% female, mean age 73.3±9.5 years) who underwent surgery (TIVAD=68; BKP=73), 126 patients (89.4%) completed the 12-month follow-up period (TIVAD=61; BKP=65). The analysis of primary endpoint on the ITT population demonstrated non-inferiority of the TIVAD to BKP. The analysis of the additional composite endpoint demonstrated the superiority of TIVAD over BKP (p<0.0001) at 6 months (88.1% vs. 60.9%) and at 12 months (79.7% vs. 59.3%). Midline VB height restoration was more improved for TIVAD than for BKP at 6 months (1.14±2.61 mm vs. 0.31±2.22 mm); p=0.0246) and 12 months after surgery (1.31±2.58 mm vs. 0.10±2.34 mm; p=0.0035). No statistically significant differences were shown between procedures for improvement in functional capacity and quality of life. Pain relief was significantly more marked in the TIVAD group compared to the BKP group at 1 month (p=0.029) and at 6 months (p=0.021) after surgery. No patient required surgical reintervention or retreatment at the treated level. No symptomatic cement leakage was reported. Adverse events were similar for both groups (41.2% in the TIVAD group and 45.2% in the BKP group). The incidence of adjacent fractures was significantly lower after the TIVAD procedure than after BKP (12.9% vs. 27.3%; p=0.043). CONCLUSIONS: Study results demonstrated non-inferiority of the TIVAD to the predicate BKP with an excellent risk/benefit profile for results up to 12 months.

Fratura traumática da coluna torácica limitada entre T1 e T10 / Traumatic thoracic spine fractures limited between T1 and T10

Objetivo: Estudo retrospectivo de uma série de 79 pacientes com fratura traumática da coluna torácica,limitada entre T1 e T10,hospitalizados entre 1995 e 2004 no Serviço de Neurocirurgia do Centro Hospitalar Universitário(CHU), Norte de Marseille, França.Métodos:As fraturas foram classificadas de acordo com a classificação da AO(Arbeitsgemeinschaft für Osteosynthesefragen)e o quadro neurológico por meio da classificação de Frankel na hospitalização,aos seis meses e um ano.Resultados:A etiologia mais frequente das fraturas foram os acidentes automobilísticos(68,3 por cento), e o tipo de fratura, o B(54,4 por cento); 57 pacientes foram considerados politraumatizados e 82,3 por cento apresentavam lesão medular. O tratamento cirúrgico foi empregado em 96,2 por cento dos casos, sendo a via posterior a mais utilizada com objetivo de estabilização,descompressão medular, correção do alinhamento da coluna, diminuição da dor e mobilização precoce.Conclusão:As incidências, as causas, os tipos de fraturas e os manejos destas foram analisados e comparados com a literatura e os resultados confirmaram a gravidade das lesões neste segmento da coluna, o número elevado de lesões associadas, a raridade de recuperação neurológica, assim como o benefício do tratamento cirúrgico por via posterior.

Craniocerebral penetrating injury caused by a spear gun through the mouth: case report.

The authors report a case of a craniocerebral penetrating injury caused by the shaft of a spear gun. The entry point of the spear was located in the mouth without an obvious exit point. The authors first note the presentation of the patient, whose airway was obstructed by the shaft, and then discuss the surgical procedure, which was focused on removing the shaft in an anterograde direction because of an articulated wishbone located at the tip of the shaft.

Decompressive craniectomy for severe traumatic brain injury: Evaluation of the effects at one year.

OBJECTIVE: To assess the effect on outcome (1 yr) of decompressive craniectomy performed within or after the first 24 hrs post-trauma in severely head-injured trauma patients with intractable cerebral hypertension. DESIGN: Retrospective cohort study. SETTINGS: Intensive care unit of a university hospital. PATIENTS: Among 816 patients with severe head trauma (Glasgow Coma Scale < or =8), 40 underwent decompressive craniectomy. After data collection, patients were divided into two groups: early and late decompressive craniectomy. An early decompressive craniectomy was performed within the first 24 hrs in patients according to the following criteria: a Glasgow Coma Scale score <6 and the existence of clinical signs of cerebral herniation (absence of pupillary reflexes), correlated with abnormalities in computed tomography scan including hematoma, appearance of diffuse or unilateral brain swelling, and/or cerebral herniation. The intracranial pressure in these patients was not measured before the decompressive craniectomy was performed. A late decompressive craniectomy (>24 hrs) was performed according to following criteria: an intractable intracranial hypertension with intracranial pressure >35 mm Hg, a unilateral or bilateral absence of pupillary reflexes, and the same abnormalities in computed tomography scan as previously described. INTERVENTION: Twenty-seven patients with signs of cerebral herniation required the procedure at the time of initial evacuation of a mass lesion. In 13 patients, decompressive craniectomy was performed because of elevated intracranial pressure refractory to medical treatment consisting of cerebrospinal fluid derivation, deep sedation, osmotherapy, hyperventilation, and nesdonal or propofol. MEASUREMENTS AND MAIN RESULTS: Five patients (19%) in whom an early decompressive craniectomy was performed had good recoveries (social rehabilitation), eight patients (30%) remained in a persistent vegetative state or with a severe disability, and 14 died (52%). On the other hand, the performance of late decompressive craniectomy in case of medical treatment failure was followed by social rehabilitation in five patients (38%) and death in three patients (23%). A persistent vegetative state or a severe disability was observed in five patients (38%). Meningitis or cerebral abscess occurred in six patients after decompressive craniectomy and were easily cured by antibiotic treatment. CONCLUSIONS: In 40 patients with intractable intracranial hypertension and at very high risk of brain death, decompressive craniectomy allowed 25% of patients to attain social rehabilitation at 1 yr.