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.

[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.

Risk factors for surgical site infections after neurosurgery: A focus on the postoperative period.

BACKGROUND: Surgical site infection (SSI) after neurosurgery has potentially devastating consequences. METHODS: A prospective cohort study was conducted over a period of 24 months in a university center. All adult patients undergoing neurosurgical procedures, with exception of open skull fractures, were included. Multivariate logistic regression analysis was used to identify independent risk factors. RESULTS: We included 949 patients. Among them, 43 were diagnosed with SSI (4.5%). A significant reduction in postneurosurgical SSI from 5.8% in 2009 to 3.0% in 2010 (P = .04) was observed. During that period, an active surveillance with regular feedback was established. The most common microorganisms isolated from SSI were Staphylococcus aureus (23%), Enterobacteriaceae (21%), and Propionibacterium acnes (12%). We identified the following independent risk factors for SSI postcranial surgery: intensive care unit (ICU) length of stay ≥7 days (odds ratio [OR] = 6.1; 95% confidence interval [CI], 1.7-21.7), duration of drainage ≥3 days (OR = 3.3; 95% CI, 1.1-11), and cerebrospinal fluid leakage (OR = 5.6; 95% CI, 1.1-30). For SSIs postspinal surgery, we identified the following: ICU length of stay ≥7 days (OR = 7.2; 95% CI, 1.6-32.1), coinfection (OR = 9.9; 95% CI, 2.2-43.4), and duration of drainage ≥3 days (OR = 5.7; 95% CI, 1.5-22). CONCLUSION: Active surveillance with regular feedback proved effective in reducing SSI rates. The postoperative period is associated with overlooked risk factors for neurosurgical SSI. Infection control measures targeting this period are therefore promising.