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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., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF) of traumatic origin. We enrolled 103 patients (median age: 61.6 years) with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS). Secondary outcomes were Oswestry Disability Index (ODI), EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score) and in quality of life (increase 21.1% of EQ-VAS score) were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (-5.4 ± 6.3°; p < 0.001), remained at 12 months (-4.4 ± 6.0°, p = 0.002). No adverse events were implant-related and none required device removal. Three patients (2.9%) experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery.

Pregnancy-associated osteoporosis usually appears during the first pregnancy and does not affect the followings. We report two cases where non-traumatic fractures have been diagnosed shortly after delivery of second pregnancies. Wide investigations could not find a cause of secondary osteoporosis. In the first case we came to the diagnosis of pregnancy-associated osteoporosis and an intravenous treatment of ibandronate has been prescribed. In the second case the bone mineral density (BMD) being almost normal and the localisation of the fracture being atypical, we concluded to a fracture of non-osteoporotic origin, probably due to mechanical stress during pregnancy. No therapy against osteoporosis has been prescribed.

Vertebral osteoporotic fracture (VOF) is a major problem of public health. Surgical treatments such as vertebroplasty and kyphoplasty are interesting adjuvant treatments for the management of osteoporosis. A consensus proposed by the principal contributors of this management is important. Regarding the actual data, we propose a vertebroplasty or a kyphoplasty for all patients suffering of an acute VOF. If a previous kyphosis or an important local kyphosis exists, secondary to the acute VOF or others, we propose a kyphoplasty. If the VOF is older and the conservative treatment is inefficient, we propose a vertebroplasty. In all cases, a specific management and treatment of osteoporosis is proposed.

Our aim was to assess the clinical outcome of patients who were subjected to long-axis sacroplasty for the treatment of sacral insufficiency fractures. Nineteen patients with unilateral (n = 3) or bilateral (n = 16) sacral fractures were involved. Under local anaesthesia, each patient was subjected to CT-guided sacroplasty using the long-axis approach through a single entry point. An average of 6 ml of polymethylmethacrylate (PMMA) was delivered along the path of each sacral fracture. For each individual patient, the Visual Analogue pain Scale (VAS) before sacroplasty and at 1, 4, 24 and 48 weeks after the procedure was obtained. Furthermore, the use of analgesics (narcotic/nonnarcotic) along with the evolution of post-interventional patient mobility before and after sacroplasty was also recorded. The mean pre-procedure VAS was 8±1.9 (range, 2 to 10). This rapidly and significantly (P<0.001) declined in the first week after the procedure (mean 4±1.4; range, 1 to 7) followed by a gradual and significant (P<0.001) decrease along the rest of the follow-up period at 4 weeks (mean 3±1.1; range, 1 to 5), 24 weeks (mean 2.2±1.1; range, 1 to 5) and 48 weeks (mean 1.6±1.1; range, 1 to 5). Eleven (58%) patients were under narcotic analgesia before sacroplasty, whereas 8 (42%) patients were using nonnarcotics. Corresponding values after the procedure were 2/19 (10%; narcotic, one of them was on reserve) and 10/19 (53%; non-narcotic). The remaining 7 (37%) patients did not address post-procedure analgesic use. The evolution of post-interventional mobility was favourable in the study group as they revealed a significant improvement in their mobility point scale (P<0.001). Long-axis percutaneous sacroplasty is a suitable, minimally invasive treatment option for patients who present with sacral insufficiency fractures. More studies with larger patient numbers are needed to explore any unrecognised limitations of this therapeutic approach.

Percutaneous vertebro-plasty is an efficient treatment of the symptomatic vertebral compression fracture refractory to optimal medical therapy. The procedure is used for neoplastic lesions, aggressive angioma, but also osteoporotic compression fractures. In order to adequately advice our patients, it is essential to know its indications and possible complications. However, to practice a vertebro-plasty for an osteoporotic compression fracture without any long term management of the osteoporotic disease is useless. Unfortunately, it still happens too often and it is essential that orthopedic surgeons, general practitioner, radiologist, rheumatologist, and any practitioners work together to guarantee the optimal management of our patients.

Sacral insufficiency fractures constitute clinical challenges because no effective surgical techniques can be applied and only a conservative treatment is currently performed. Sacroplasty is increasingly used to treat sacral insufficiency fractures. A computed tomography (CT)-guided technique concerning the placement of the sacroplasty needles within the sacral wings by using a laser alignment light guidance associated with a CT gantry tilt in a plane parallel to the sacral bone is presented. This method allowed a fast and precise placement of the needle in and along the sacral wings, thus preventing the use of multiple needles to reach the fracture sites.

Sacral insufficiency fracture is a debilitating injury for which no active treatment is currently available. It frequently causes significant pain and limits activities of daily living in patients with osteoporosis. Percutaneous vertebroplasty is a common procedure to alleviate the pain associated with thoracic and lumbar vertebral compression fractures. The sacral percutaneous cimentoplasty procedure (sacroplasty) has recently been introduced as an alternative to medical management of osteoporotic sacral insufficiency fractures. The purpose of this article is to illustrate the effectiveness and the utility of percutaneous sacroplasty in this kind of pathology and to show how this procedure can provide symptom relief without having major complications.

We report preliminary results for unstable sacral fractures treated with a modified posterior triangular osteosynthesis. Seven patients were admitted to our trauma center with an unstable sacral fracture. The average age was 31 years (22-41). There were four vertical shear lesions of the pelvis and three transverse fracture of the upper sacrum. The vertical shear injuries were initially treated with an anterior external fixator inserted at the time of admission. Definitive surgery was performed at a mean time of 9 days after trauma. The operation consisted in a posterior fixation combining a vertebropelvic distraction osteosynthesis with pedicle screws and a rod system, whereby the transverse fixation was obtained using a 6 mm rod as a cross-link between the two main rods. Late displacement of the posterior pelvis or fracture was measured on X-ray films according to the criteria of Henderson. The patients were followed-up for a minimum time of 12 months. Four patients who presented with a pre-operative perineal neurological impairment made a complete recovery. No iatrogenic nerve injury was reported. One case of deep infection was managed successfully with surgical debridement and local antibiotics. All patients complained of symptoms related to the prominence of the iliac screws. The metalwork was removed in all cases after healing of the fracture, at a mean time of 4.3 months after surgery. No loss of reduction of fracture was seen at final radiological follow-up. The preliminary results are promising. The fixation is sufficiently stable to allow an immediate progressive weight-bearing, and safe nursing care in polytrauma cases. The only problem seems to be related to prominent heads of the distal screws.

Sacral insufficiency fractures have been described in association with conditions leading to osteoporosis. No association with spondylolisthesis has been described to date. A 60-year-old patient with known lumbosacral isthmic spondylolisthesis presented with exacerbation of symptoms initially thought to be linked to her known spinal pathology. Plain radiography, computer tomography, MRI and bone scan confirmed the presence of a recent sacral insufficiency fracture with anterior angulation. Conservative treatment resulted in improvement of symptoms after 6 months. Care should be taken when considering older patients for more aggressive treatment if they present with exacerbation of back pain and sciatica in the presence of a pre-existing spondylolisthesis. A suspicion of insufficiency fracture should be raised if risk factors exist and further investigations ordered in particular if plain radiography is normal. Lumbosacral fusion might be inappropriate in this setting.

Although vertebroplasty was initially a treatment of vertebral haemangioma or metastases, this procedure is now frequent option to the treatment of osteoporotic vertebral fractures. In this review article, we will discuss the indication, the techniques and the follow-up of the vertebroplasty. This is a risky procedure, which should be performed by experimented physicians working with high-resolution fluoroscopic equipments, by biplane fluoroscopy, to reduce the risk and irradiation to the patient. According to the available follow-up studies, there is clear evidence of a strong improvement of quality of life after vertebroplasty by rapid decreasing of back pain at least during the first six months. Other new studies will analyze the long-term follow-up after vertebroplasty.

Purpose: To determine if multi-detector row computed tomography (CT) can replace conventional radiography and be performed alone in severe trauma patients for the depiction of thoracolumbar spine fractures., Materials and Methods: One hundred consecutive severe trauma patients who underwent conventional radiography of the thoracolumbar spine as well as thoracoabdominal multi-detector row CT were prospectively identified. Conventional radiographs were reviewed independently by three radiologists and two orthopedic surgeons; CT images were reviewed by three radiologists. Reviewers were blinded both to one another's reviews and to the results of initial evaluation. Presence, location, and stability of fractures, as well as quality of reviewed images, were assessed. Statistical analysis was performed to determine sensitivity and interobserver agreement for each procedure, with results of clinical and radiologic follow-up as the standard of reference. The time to perform each examination and the radiation dose involved were evaluated. A resource cost analysis was performed., Results: Sixty-seven fractured vertebrae were diagnosed in 26 patients. Twelve patients had unstable spine fractures. Mean sensitivity and interobserver agreement, respectively, for detection of unstable fractures were 97.2% and 0.951 for multi-detector row CT and 33.3% and 0.368 for conventional radiography. The median times to perform a conventional radiographic and a multi-detector row CT examination, respectively, were 33 and 40 minutes. Effective radiation doses at conventional radiography of the spine and thoracoabdominal multi-detector row CT, respectively, were 6.36 mSv and 19.42 mSv. Multi-detector row CT enabled identification of 146 associated traumatic lesions. The costs of conventional radiography and multi-detector row CT, respectively, were 145 and 880 US dollars per patient., Conclusion: Multi-detector row CT is a better examination for depicting spine fractures than conventional radiography. It can replace conventional radiography and be performed alone in patients who have sustained severe trauma.