Neuromuscular ultrasound changes in unilateral symptomatic subacute lumbosacral radiculopathy: A prospective simple blinded cohort study.

INTRODUCTION/AIMS: Lumbosacral radiculopathy (LR) is a common disorder. Neuromuscular ultrasound (NMU) is a rapidly evolving technique for the investigation of peripheral nerve and muscle disorders, but studies using NMU in LR are lacking. The aim of the present study was to investigate ultrasonographic neuromuscular changes distant from root compression in patients with subacute to chronic compressive LR with motor impairment. METHODS: Patients with unilateral subacute to chronic L4, L5, or S1 radiculopathy with motor impairment and confirmed by magnetic resonance imaging were included. The sciatic and femoral nerve cross-sectional areas (CSA), the CSA of lower limb muscles, and muscle fasciculation detection rate were assessed using a pre-specified neuromuscular ultrasound evaluation with blinded side-to-side comparison. RESULTS: Of the 18 included patients, 66% were male and the mean age was 51 years. Overall, 16.7% had L4, 55.5% L5, and 27.8% S1 radiculopathy, mostly due to disc herniation (83%). Sciatic nerve CSA of the symptomatic side was increased (61.4 mm2 vs. 51.3 mm2; p = .001), and the fasciculation detection rate was higher in the affected muscles (delta = 13%, p = .007) compared to unaffected ones. Muscle CSA in affected and nonaffected muscles was decreased on the symptomatic side. DISCUSSION: NMU evaluation in patients with symptomatic subacute to chronic LR revealed sciatic nerve enlargement distant from nerve root compression and higher fasciculation rates. These structural findings on NMU might be due to an axonal repair mechanism and an inflammatory response with endoneurial edema induced by ongoing nerve damage and potentially reflect progressive axonal loss.

Height Restoration for Vertebra Plana Using a Mechanical Lamellar Vertebral Body Reduction Device: 2-Dimensional Operative Video.

Compression fractures of thoracolumbar vertebra are the most common vertebral fracture.1 Associated with osteoporosis, the compression can progress until reach vertebra plana and cause a kyphosis.2 The reduction of the fresh fracture and restoration of the height are the purposes of the kyphoplasty.3 We present a modified technique adapted for the treatment of vertebral plana using a mechanical flexible lamellar vertebral body reduction device (Tektona, Spinart).4 We present the case of a 77-year-old woman with back pain after a fall. The radiological investigations show a compressive fracture type AO A1 of T7. After an initial conservative management, the patient presented persistence of the pain with a visual analog scale of 9/10 and progression of the fracture at the 2-week follow-up. On the x-ray, focal kyphosis with vertebra plana was observed. A kyphoplasty for pain management and kyphosis correction was performed. The patient consented to the procedure. A bipedicular approach to the vertebra was performed. The correction of the height was done using 2 mechanical devices. The lamellar device allowed a progressive height restoration of the fracture. On one side, the cannula was used as a support to maintain the correction during the contralateral cementing. The postoperative imaging confirmed a maintained vertebral restoration with kyphosis correction. At 1 year, the patient reported a pain at 1 of 10 on the visual analog scale. In our opinion, this technique is adapted for fresh osteoporotic vertebral compression fractures. Surgical experience in osteoporotic fracture treatment and kyphoplasty is recommended before the management of vertebra plana.

Vertebral Augmentation: Is It Time to Get Past the Pain? A Consensus Statement from the Sardinia Spine and Stroke Congress.

Vertebral augmentation has been used to treat painful vertebral compression fractures and metastatic lesions in millions of patients around the world. An international group of subject matter experts have considered the evidence, including but not limited to mortality. These considerations led them to ask whether it is appropriate to allow the subjective measure of pain to so dominate the clinical decision of whether to proceed with augmentation. The discussions that ensued are related below.

Beta Electroencephalographic Oscillation Is a Potential GABAergic Biomarker of Chronic Peripheral Neuropathic Pain.

This preliminary investigation aimed to assess beta (ß) oscillation, a marker of the brain GABAergic signaling, as a potential objective pain marker, hence contributing at the same time to the mechanistic approach of pain management. This case-control observational study measured ß electroencephalographic (EEG) oscillation in 12 right-handed adult male with chronic neuropathic pain and 10 matched controls (∼55 years). Participants were submitted to clinical evaluation (pain visual analog scale, Hospital Anxiety, and Depression scale) and a 24-min high-density EEG recording (BIOSEMI). Data were analyzed using the EEGlab toolbox (MATLAB), SPSS, and R. The global power spectrum computed within the low (Lß, 13-20 Hz) and the high (Hß, 20-30 Hz) ß frequency sub-bands was significantly lower in patients than in controls, and accordingly, Lß was negatively correlated to the pain visual analog scale (R = -0.931, p = 0.007), whereas Hß correlation was at the edge of significance (R = -0.805; p = 0.053). Patients' anxiety was correlated to pain intensity (R = 0.755; p = 0.003). Normalization of the low and high ß global power spectrum (GPS) to the GPS of the full frequency range, while confirming the significant Lß power decrease in chronic neuropathic pain patients, vanished the significance of the Hß decrease, as well as the correlation between Lß power and pain intensity. Our results suggest that the GABAergic Lß EEG oscillation is affected by chronic neuropathic pain. Confirming the Lß GPS decrease and the correlation with pain intensity in larger studies would open new opportunities for the clinical application of gamma-aminobutyric acid-modifying therapies.

Superior Osteo-Inductive and Osteo-Conductive Properties of Trabecular Titanium vs. PEEK Scaffolds on Human Mesenchymal Stem Cells: A Proof of Concept for the Use of Fusion Cages.

Fusion cages composed of titanium and its alloys are emerging as valuable alternative to standard polyetheretherketone (PEEK) ones routinely used in cervical and lumbar spine surgery. Aim of this study was to evaluate osteo-inductive and osteo-conductive ability of an innovative trabecular titanium (T-Ti) scaffold on human mesenchymal stem cells (hMSCs), in both absence and presence of biochemical osteogenic stimuli. Same abilities were assessed on PEEK and standard 2D plastic surface, the latter meant as gold-standard for in vitro differentiation studies. hMSCs adhered and colonized both T-Ti and PEEK scaffolds. In absence of osteogenic factors, T-Ti triggered osteogenic induction of MSCs, as demonstrated by alkaline phosphatase activity and calcium deposition increments, while PEEK and standard 2D did not. Addition of osteogenic stimuli reinforced osteogenic differentiation of hMSCs cultured on T-Ti in a significantly higher manner with respect to standard 2D plastic culture surfaces, whereas PEEK almost completely abolished the process. T-Ti driven differentiation towards osteoblasts was confirmed by gene and marker expression analyses, even in absence of osteogenic stimuli. These results clearly indicate superior in vitro osteo-inductive and osteo-conductive capacity of T-Ti compared to PEEK, and make ground for further studies supporting the use of T-Ti cages to improve bone fusion.

Compressive cervicothoracic pseudomeningocele as a rare manifestation of idiopathic intrathecal hypotension after past trauma: a review.

PURPOSE: Spontaneous intracranial or intrathecal hypotension (SIH) is an underdiagnosed phenomenon predominantly presenting with low cerebrospinal fluid (CSF) pressure and postural headache in the setting of CSF leak. Extrathecal CSF collections causing compression of the spinal cord or nerve roots present an even rarer subset of this disease. We aim to describe this pathology in a comprehensive manner while illustrating with a case of our own. METHODS: We present a literature review on spinal idiopathic pseudomeningoceles and their neurological implications illustrated with a case of an anterior compressive pseudomeningocele between C2 and D7. Further investigations through a myelography and myelo-CT were able to postulate a CSF leak through a discogenic osteophytic microspur at the level C5-C6. RESULTS: Spinal manifestations are uncommon in cases of idiopathic or spontaneous CSF leak, occurring in about 6% of patients, but myelopathy and radiculopathy involving all spinal segments do occur. In contrast to the cranial complaints, the spinal manifestations usually are not positional and are caused by mass effect from an extradural CSF collection. CONCLUSION: The utility of multiple imaging modalities such as dynamic myelography and the use of epidural blood patches and fibrin glue polymers should be explored, and surgery is an option if the symptoms persist despite other measures.

Osteogenic potential of human adipose derived stem cells (hASCs) seeded on titanium trabecular spinal cages.

Spine degenerative conditions are becoming increasingly prevalent, affecting about 5.7% of the population in Europe, resulting in a significant reduction of life's quality. Up to now, many materials have been used in manufacturing cage implants, used as graft substitutes, to achieve immediate and long-term spinal fixation. Particularly, titanium and its alloys are emerging as valuable candidates to develop new types of cages. The aim of this in vitro study was to evaluate the adhesion, proliferation and osteogenic differentiation of adipose derived mesenchymal stem cells (ASCs) seeded on trabecular titanium cages. ASCs adhered, proliferated and produced an abundant extracellular matrix during the 3 weeks of culture. In the presence of osteogenic medium, ASCs differentiated into osteoblast-like cells: the expression of typical bone genes, as well as the alkaline phosphatase activity, was statistically higher than in controls. Furthermore, the dispersive spectrometry microanalysis showed a marked increase of calcium level in cells grown in osteogenic medium. Plus, our preliminary data about osteoinduction suggest that this titanium implant has the potential to induce the ASCs to produce a secretome able to trigger a shift in the ASCs phenotype, possibly towards the osteogenic differentiation, as illustrated by the qRT-PCR and ALP biochemical assay results. The trabecular porous organization of these cages is rather similar to the cancellous bone structure, thus allowing the bone matrix to colonize it efficiently; for these reasons we can conclude that the architecture of this cage may play a role in modulating the osteoinductive capabilities of the implant, thus encouraging its engagement in in vivo studies for the treatment of spinal deformities and diseases.

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.

Segmentation failure of the posterior elements at the cervical spine and cervicothoracic junction: report of three cases.

PURPOSE: Vertebral segmentation and fusion failures are quite common and often occur as incidental findings. These anatomical variants may be associated with deformity and lead to pain and other neurological signs. They are less frequent in the cervical spine. We report three cases of rare posterior arch segmentation failure at the cervical spine and cervicothoracic junction, with an interesting pattern of laminar arrangement. METHODS: The clinical and radiological findings of three patients with unusual anatomical variants of the posterior elements of the subaxial cervical spine and cervicothoracic junction are reported. RESULTS: We found various association of scoliosis, partial butterfly vertebra, absent pedicle, transverse process and lateral mass anomalies. Interestingly, we report two different and unusual laminar morphologies. CONCLUSION: Congenital morphological disorders may occur at the lower cervical spine and cervicothoracic junction, and they can involve the vertebral body as well as the posterior arch. We reported three cases of uncommon malformations, with a unique Y- and S-shaped laminar pattern.

Pott's puffy tumor presenting as a frontal swelling under a Swiss army helmet.

In this report, we describe an uncommon presentation of a Pott's puffy tumor, which is defined as a subperiosteal abscess related to a chronic frontal sinusitis. This condition has become rare in our part of the world because of the widespread use of antibiotics. Clinical history, investigations, and management are presented.

Anterior decompression and plate fixation in treatment of cervical myelopathy: A multicentric retrospective review.

OBJECTIVES: The aim of this study was to evaluate the results on anterior decompression and fusion with titanium mesh or expanding cage and plate fixation in patients with cervical myelopathy. METHODS: We conducted a retrospective multicentric review of 114 patients, 75 males and 39 females, with cervical myelopathy who underwent surgical treatment between July 2009 to December 2011. All surgeries were performed via a ventral approach. Based on the type of surgery the patients received, they were divided into 3 groups: group 1 consisted of 49 patients who received multilevel corpectomies and fusion with strut iliac bone graft and plates; group 2 consisted of 26 patients who received multilevel corpectomies and fusion with titanium expanding cage and plating; group 3 consisted of 39 patients who received multilevel corpectomies and fusion using titanium mesh with autologous bone graft and anterior plating. RESULTS: Decompression of the cervical spinal cord and grafting with plate fixation via a ventral approach demonstrated a high rate of improvement in neurological function with minimal complications. Fusion was documented radiologically in all cases. Eighty-three patients experienced a partial improvement and 41 had a complete recovery according to Nurick's myelopathy grading. Sixty-two patients were ranked as excellent, 48 as good, 4 as fair; unsatisfactory outcome was related to donor site complications. CONCLUSION: Spinal decompression and fusion with titanium cages and plates appears to be a safe and effective alternative in patients with cervical spinal myelopathy. LEVEL OF EVIDENCE: Level IV, therapeutic study.

Efficacy of teriparatide vs neridronate in adults with osteogenesis imperfecta type I: a prospective randomized international clinical study.

Osteogenesis imperfecta (OI) is an hereditary disease characterized by low bone mass, increased bone fragility, short stature, and skeletal deformities, few treatment options are currently available. Neridronate is an amino-bisphosphonate, licensed in Italy for the treatment of OI and Paget's disease of bone. A characteristic property of neridronate is that it can be administered both intravenously and intramuscularly, providing an useful system for administration in homecare. Neridronate appears to increase Bone Mineral Density (BMD) in adults with OI and reduces bone resorption by inhibition of osteoclastic activity. Teriparatide (recombinant 1-34 N terminal sequence of human parathyroid hormone) is the first anabolic agent approved for the treatment of patients with osteoporosis and has been reported to increase bone formation by stimulating osteoblast differentiation, osteoblast function, and survival. The results of this study showed a promising role of teriparatide in the therapy of OI type I.

Harlequin sign concomitant with Horner syndrome after anterior cervical discectomy: a case of intrusion into the cervical sympathetic system.

Harlequin syndrome is a rare autonomic disorder referring to the sudden development of flushing and sweating limited to one side of the face. Like Horner syndrome, associating miosis, ptosis, and anhidrosis, Harlequin syndrome is caused by disruption of the cervical sympathetic pathways. Authors of this report describe the case of a 55-year-old female who presented with both Harlequin sign and Horner syndrome immediately after anterior cervical discectomy (C6-7) with cage fusion and anterior spondylodesis. They discuss the pathophysiology underlying this striking phenomenon and the benign course of this condition. Familiarity with this unusual complication should be of particular interest for every specialist involved in cervical and thoracic surgery.

Herniectomy versus herniectomy with the DIAM spinal stabilization system in patients with sciatica and concomitant low back pain: results of a prospective randomized controlled multicenter trial.

PURPOSE: To investigate the short and medium term efficacy and patient outcomes of DIAM spinal stabilization system on back pain, disability, leg pain and quality of life. METHODS: 165 patients were enrolled; 146 patients with a single level disc herniation (L2 to L5) were randomized: 75 investigational (herniectomy and DIAM) and 71 control (herniectomy alone) treated and followed up for 24 months. RESULTS: Significant improvements overtime (P < 0.001) in both groups but not significantly different between groups for visual analog scale (VAS) back pain at 6 months (investigational -3.97 ± 2.55 vs control-3.37 ± 3.15, P = 0.228) and Oswestry Disability Index (ODI) at 12 months (-38.55 ± 20.10 vs -37.19 ± 22.61, P = 0.719). For both outcomes, there was no statistically significant difference between the groups, at all postoperative time points. Although the enrolment ended before the intended sample size (308 patients) was reached, the number of patients reaching the VAS back pain minimally clinically important difference (MCID) of ≥2.2 at 6 months was higher in the investigational (79.4 % vs control 57.1 %, P = 0.008). These results were sustained throughout 24 months (82.8 vs 64.4 %, P < 0.05). In average, surgical duration (P < 0.001), blood loss (P = 0.029) and skin incision (P < 0.001) in the investigational were 10 min longer, 22.5 ml greater and 2.0 cm wider than control group (median values). Improved tertiary outcomes from BL to 24 mo in both groups (investigational vs control): VAS leg pain (mean decrease -6.41 ± 2.57 to -6.41 vs -5.61 ± to -3.30); improved quality of life (SF-36: 20.68 ± 9.44 vs 16.90 ± 10.74); pain medication reduction: 56.7 vs 47.9 %; return to work: 45.7 vs 38.0 %. Adverse event rates: 68.5 % investigational and 66.2 % control. CONCLUSIONS: This is the first randomized controlled trial to report equivalent efficacy and safety of herniectomy with or without DIAM spinal stabilizing device. Leg pain, back pain and the level of disability were not significantly different between groups; however, number of patients reaching the MCID for back pain was significantly higher in the investigational group at 6 through 24 months.

Treatment of osteoporosis secondary to hypogonadism in prostate cancer patients: a prospective randomized multicenter international study with denosumab vs. alendronate.

BACKGROUND: Osteoporosis is a complication of androgen deprivation therapy (ADT) in men with prostate carcinoma. This is a multicenter, randomized, double-blind prospective study on use of denosumab versus alendronate in the therapy of secondary osteoporosis related to ADT. METHODS: A total of 234 patients with diagnosis of osteoporosis underwent ADT for prostate cancer were enrolled. Patients were randomly assigned 1:1 to receive denosumab 60 mg subcutaneously every 6 months or alendronate (70 mg/week) for 2 years. All patient received supplemental vitamin D (600 IU/day) and supplemental calcium to maintain a calcium intake of 1200 mg per day. Effectiveness of therapy in both groups (denosumab group and alendronate group) was assessed by changes in bone turnover markers (BTMs), bone mineral density, fracture incidence, Visual Analogue Scale score for back pain, and Short Form-8 health survey score for health-related quality of life. RESULTS: In the denosumab study group, level of BTMs for bone formation were significantly increased from baseline at all time points during the study (P<0.001); in the alendronate study group level of BTMs for bone formation were increased too (P>0.05). Mean changes in BMD at final follow-up differed significantly between two groups. BMD changes at the lumbar spine at 24 months were 5.6% with denosumab vs. -1.1% with alendronate (P<0.001). CONCLUSIONS: Denosumab and alendronate showed similar clinical efficacy in the therapy of ADT-related osteoporosis in men with prostate carcinoma; both drugs provided significant improvements in back pain and general health conditions. Denosumab showed significant increase of BTMs and BMD than alendronate with lower rate of new vertebral fractures.

Denosumab is really effective in the treatment of osteoporosis secondary to hypogonadism in prostate carcinoma patients? A prospective randomized multicenter international study.

INTRODUCTION: Osteoporosis is a complication of androgen deprivation therapy (ADT) in men with prostate carcinoma. The best defense against osteoporosis in prostate cancer is to identify patients with a high risk for fracture during the first clinical visit, select an effective anti-osteoporosis agent, and advise the patient to change his lifestyle and diet to prevent further bone loss. New agents include denosumab, a human monoclonal antibody that inhibits the RANK ligand (RANKL). RANKL promotes the formation, activity, and survival of osteoclasts and, thus, supports the breakdown of bone. PURPOSE: This is a multicenter, randomized, double-blind prospective study on use of denosumab versus alendronate in the therapy of secondary osteoporosis related to ADT in prostate cancer patients in three European countries (Italy, France, Switzerland). PATIENTS AND METHODS: In this 24-month observation study we enrolled 234 patients with diagnosis of osteoporosis underwent ADT for prostate cancer. All patients aged ≥55 years and had a dual-energy X-ray absorptiometry (DEXA) T-score <-1.0 (hip or spine, measured within last 2 years) and ≥ 1 fragility fracture. Patients were randomly assigned 1:1 to receive denosumab 60 mg subcutaneously every 6 months or alendronate (70 mg weekly) for 2 years. All patient received supplemental vitamin D (600 IU per day) and supplemental calcium to maintain a calcium intake of 1200 mg per day. Effectiveness of therapy in both groups (denosumab group and alendronate group) was assessed by changes in bone turnover markers (BTMs), Bone Mineral Density (BMD), fracture incidence, Visual Analogue Scale (VAS) score for back pain, and Short Form-8 (SF-8TM) health survey score for health-related quality of life (HRQoL). Percent changes from baseline in BTMs and BMD were assessed using the paired t test; a P-value 0.05). Mean changes in BMD at final follow-up differed significantly between two groups. BMD changes at the lumbar spine at 24 months were 5.6% with denosumab vs -1.1% with alendronate (P<0.001). New vertebral fractures developed in fewer patients in the denosumab group than in the alendronate group during the 24-month period, although this difference was not significant (P=0.10). Back pain significantly (P<0.001) improved from baseline at all time points during the study in both study groups. SF-8 health survey scores significantly improved following treatment with both drugs. Incidence of adverse drug reactions were similar in both groups. CONCLUSION: In our study denosumab and alendronate showed similar clinical efficacy in the therapy of ADT-related osteoporosis in men with prostate carcinoma; both drugs provided significant improvements in back pain and general health conditions. Denosumab showed significant increase of BTMs and BMD than alendronate with lower rate of new vertebral fractures.

Safety and efficacy of vertebroplasty in the treatment of osteoporotic vertebral compression fractures: a prospective multicenter international randomized controlled study.

BACKGROUND: Vertebral compression fractures (VCFs) treated non-operatively can diminish function and quality of life, and lead to chronic health effects. The short-term safety and effectiveness of vertebroplasty for symptomatic VCFs are well-documented, but long-term follow-up is needed. PURPOSE: The aim of this paper was to analyse a multicenter international experience of 200 compression fractures treated with percutaneous vertebroplasty (VP) and compare the results of this procedure with the result of 200 patients treated conservatively. To estimate cost-effectiveness of VP compared to conservative care in terms of: pain reduction, quality of life, complications, secondary fractures and mortality. MATERIALS AND METHODS: 400 patients have been enrolled in a prospective randomized controlled study with painful VCFs with bone edema on MR imaging, local back pain for 6 weeks or less, osteoporosis and aged 55 years or older; after obtaining informed consent patients are included and randomized for VP or conservative care. Before treatment and at follow-up with regular intervals during 1-year period were administered to patients standard questionnaires addressing: clinical symptoms, pain medication, Visual Analogue Scale (VAS) score for pain, Oswestry Disability Index (ODI) score to evaluate functional activity. RESULTS: 200 patients treated with PV compared with 200 patients treated conservatively had significantly better VAS and used less analgesics 1 day after treatment. Twenty-four hours after VP, there was a reduction in pain scores and an improvement in physical functions, whereas remain unchanged in the patients treated conservatively. CONCLUSIONS: Pain relief and improvement of mobility and function after PV is immediate and significantly better in the short term compared with non-surgical care treatment.

Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study.

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.

Sacroiliac joint syndrome 10 years after lumbar arthroplasty: the importance of spinopelvic alignment.

INTRODUCTION: Sagittal balance is an independent predictor of outcomes in spinal care and several authors focused their attention on the lumbar lordosis restoration as the key point to prevent secondary sacroiliac joint dysfunction (SIJD) after fusion. On the other hand, lumbar disc arthroplasty allows preservation of motion avoiding increased stress on the spinopelvic junction and preventing iatrogenic sagittal imbalance. METHODS: We analyze the incidence of a secondary SIJD and the spinopelvic alignment on a series of 31 consecutive lumbar disc prosthesis with a 10-year follow-up. RESULTS: Sagittal balance assessment showed no significant variation of preoperative spinopelvic parameters. Four patients (12 %) presented a symptomatic SIJD. Only two of them required a percutaneous SIJ fixation. Both of them presented a fused L5-S1 prosthesis. CONCLUSIONS: The low rate of SIJD 10 years after lumbar arthroplasty might be explained by the preservation of the spinopelvic balance.