Bioceramic vertebral augmentation with a calcium sulphate/hydroxyapatite composite (Cerament™ SpineSupport) in vertebral compression fractures due to osteoporosis

A prospective, non-randomized multicenter study was initiated to study efficacy and safety of a partly resorbable composite of calcium sulphate and hydroxyapatite (Cerament™ SpineSupport), a novel, injectable bioceramic, in osteoporotic patients with vertebral compression fractures during 18-month follow-up. Fifteen patients with low-energy trauma and 1–2 vertebral compression fractures verified by magnetic resonance imaging were recruited to undergo percutaneous bioceramic vertebral augmentation under fluoroscopy. The patients were treated with a highly flowable bioceramic containing calcium sulphate, hydroxyapatite and the non-ionic radiocontrast agent iohexol, with final setting time within 1 h. After the procedure, the patients were allowed to mobilize after 2 h. Pain (VAS), occurrence of remote and adjacent fractures, and Quality of Life (QoL; SF-36 and EQ-5D) was recorded during 18 months. The injected volume of the composite material ranged from 2.8 to 9 mL (mean 4.2 mL). Pre-operative VAS score was mean 70.3 (CI95% ±8.7) with an immediate post-operative pain relief, which was maintained at the 4-week visit (mean 26.4 with CI95% ±16.1) and 8-week visit (mean 18.0 with CI95% ±13.5 pain relief). Eighty percent of the patients demonstrated a clinical improvement. The pain relief was maintained over 18 months and no adjacent fractures were observed. There was a statistically significant improvement of physical components in the QoL assessment. No extra-vertebral leakage or neurological deficits were reported in this series. This first prospective multicenter study on a partly resorbable bioceramic material indicate that fracture healing can be achieved with sustained pain relief over a follow-up period of 18 months in an osteoporotic patient population with vertebral compression fractures.     

Safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot,monocentric, investigator-initiated study

Summary

Clinical performance and safety of two percutaneous vertebral cement augmentation (VA) procedures (SpineJack® and Kyphx Xpander® balloon) were compared in patients with osteoporotic compression fractures. Both techniques were safe, efficient, and led to a rapid and marked improvement in clinical signs; nevertheless, SpineJack showed better restoration of vertebral heights and angles, maintained over time.

Introduction

In patients with osteoporotic vertebral compression fractures (VCFs), both SpineJack® (SJ) and balloon kyphoplasty (BKP) led to a rapid and marked improvement in clinical signs. This pilot, monocentric, investigator-initiated, prospective study aimed to compare two percutaneous vertebral augmentation procedures in the painful osteoporotic VCF treatment.

Methods

Thirty patients were randomized to receive SJ (n?=?15) or BKP (n?=?15). Analgesic consumption, back pain intensity (visual analog scale (VAS)), and Oswestry Disability Index (ODI) scores were recorded preoperatively, at 5 days and 1, 3, 6, and 12 months post-surgery. Quality of life (EQ-VAS score) was evaluated at 1, 3, 6, and 12 months. Spine X-rays were taken 48 h prior to procedure and 5 days and 6 and 12 months after.

Results

SpineJack® led to a significantly shorter intervention period (23 vs 32 min; p?<?0.001), a strong, rapid, and long-lasting decline in pain (94 vs 82 % at 12 months) and in functional disability (94 vs 90 % at 12 months), a greater and sustainable mean correction of anterior (12?±?13 vs 0?±?7 % for BKP, p?=?0.003) and central height (12?±?10 vs 2?±?6 % for BKP, p?=?0.001) at 12 months, and a larger restoration of the vertebral body angle still evident 12 months after implantation (?4.4°?±?5.8° vs 0.2°?±?3.0° for BKP; p?=?0.012).

Conclusions

This pilot study showed that both techniques were safe and efficient for the osteoporotic VCF treatment. Radiological results indicate that the SpineJack® procedure has a higher potential for vertebral body height restoration and maintenance over time.

     

Cooperative effect of serum 25-hydroxyvitamin D concentration and a polymorphism of transforming growth factor-β1 gene on the prevalence of vertebral fractures in postmenopausal osteoporosis

A T869→C polymorphism of the transforming growth factor-β1 (TGF-β1) gene is reported to be associated with genetic susceptibility to both osteoporosis and vertebral fractures. A low serum 25-hydroxyvitamin D [25(OH)D] level is known to be associated with a higher risk for hip fracture. This study aimed to assess a possible cooperative effect of the gene polymorphism and vitamin D status on vertebral fracture risk. The prevalence of vertebral fracture in 168 postmenopausal female patients with osteoporosis was analyzed, and its association with the TGF-β1 gene polymorphism and serum 25(OH)D concentration was assessed cross-sectionally. The fracture prevalence increased according to the rank order of the TGF-β1 genotypes CC < CT < TT, as expected. A significant difference was found not only between the CC and TT genotypes (P = 0.005) but also between the CC and CT genotypes (P < 0.05) when the patients with serum 25(OH)D of more than the median value [22 ng/ml (55 nmol/l)] were analyzed. On the other hand, when those with serum 25(OH)D of less than the median value were analyzed, the protective effect of the C allele against the fracture was blunted; statistical significance in the difference of the fracture prevalence was lost between the CC genotype and the other genotypes. These data suggest that vitamin D fulfillment is prerequisite for the TGF-β1 genotype in exerting its full effect on the fracture prevalence.     

Effects of 1α-hydroxyvitamin D3 on lumbar bone mineral density and vertebral fractures in patients with postmenopausal osteoporosis

The effects of 1-hydroxyvitamin D₃ [1(OH)D₃] on bone mineral density, fracture incidence, and bone metabolism were evaluated by a double-blind, placebo-controlled study. Eighty postmenopausal osteoporotic Japanese women (71.9±7.3 years, mean±SD) were randomly assigned to 1 g of 1(OH)D₃ daily or inactive placebo for 1 year. All patients were given supplemental calcium (300 mg of elemental calcium daily). Lumbar (L2–L4) bone mineral density (BMD) determined by dual energy X-ray absorptiometry increased 0.65% with 1(OH)D₃ treatment and decreased 1.14% with placebo (P=0.037). BMD in both the femoral neck and Ward's triangle did not yield any significant differences between the two groups, whereas trochanter BMD in the 1(OH)D₃-treated group increased 4.20% and decreased 2.37% with placebo (P=0.055). X-ray analysis demonstrated that new vertebral fractures occurred in two patients with 1(OH)D₃ and in seven patients with placebo. The vertebral fracture rate in the treated group was significantly less (75/1000 patient years) than in the control group (277/1000 patient years; P=0.029). Hypercalcemia (12.1 mg/100 ml) occurred in one patient receiving 1(OH)D₃; however, the serum calcium level in this patient promptly decreased to the reference range after cessation of the treatment. There were no significant changes in serum creatinine level in either group. A significant increase in urinary excretion of calcium was found but there was no significant change in urinary excretion of hydroxyproline in the treated group. The serum level of bone-derived alkaline phosphatase activity significantly decreased by–26±26 (mU/ml) after the treatment (P=0.003). These results indicate that 1(OH)D₃ treatment is effective for maintaining trabecular bone mass and prevents further vertebral fractures without any serious adverse effects in postmenopausal osteoporosis.     

Spinal trauma in DISH and AS: is MRI essential following the detection of vertebral fractures on CT?

BACKGROUNDBoth ankylosing spondylitis (AS) and diffuse idiopathic skeletal hyperostosis (DISH) cause a rigid spine, but through different pathophysiology. Recent data has shown that characteristic fracture patterns may also differ following trauma since the posterior osseous and soft tissue elements are often spared in DISH. CT and MRI are important in diagnosing spine injury, but given the differences between AS and DISH, the utility of obtaining both studies in all patients warrants scrutiny.PURPOSETo assess the prevalence of posterior element injury on CT and MRI in DISH and AS patients with known vertebral body injury detected on CT; to determine whether MRI demonstrates additional injuries in neurologically intact patients presumed to have isolated vertebral body injuries on CT.STUDY DESIGNMulticenter, retrospective, case-control study.PATIENT SAMPLEDISH and AS patients presenting after spine trauma between 2007 and 2017.OUTCOME MEASURESReview of CT and MRI findings at the time of presentation.METHODSOne hundred sixty DISH and 85 AS patients presenting after spine trauma were identified from 2 affiliated academic hospitals serving as level 1 trauma and tertiary referral centers. A diagnosis of DISH or AS was verified by a board-certified emergency radiologist with 3 years of experience. Age, gender, mechanism of injury, fracture type, spine CT and MRI imaging findings, surgical intervention, and neurologic deficit were recorded. The CT and MRI studies were reviewed by the same radiologist for fracture location and type using the AO spine classification. No funding source or conflict of interest was present.RESULTSMedian age was 72 and 79 years old for the AS and DISH groups, respectively. Both were predominantly male (81%) and most presented after a low energy mechanism of injury (74% and 73%). Type C AO spine injuries were seen in 52% of AS patients but only 4% of DISH patients. In patients with known vertebral body injury on CT, additional injury to the posterior elements on CT or MRI in DISH patients was 51% versus 92% in AS patients. However, in patients with an isolated vertebral body fracture on CT and no neurological deficit, MRI identified posterior element injury in only 4/22 (18%) DISH patients compared to 5 of 7 (71%) AS patients. None of the MRI findings in the DISH patients were considered clinically important while all 5 AS patients eventually underwent operative treatment despite having no neurological deficit. Epidural hematoma on MRI was seen in 43% of AS patients as opposed to 5% of DISH patients.CONCLUSIONBased on our small sample size, CT alone may be adequate in DISH patients with isolated vertebral body fractures and no neurologic deficit, but an additional MRI should be considered in the presence of an unclear neurological exam or deficit. MRI should be strongly considered for any AS patient regardless of neurologic status.     

Dural injury following elective spine surgery – A prospective analysis of risk factors,management and complications

Incidental dural tears being a familiar complication in spine surgery could result in dreaded postoperative outcomes. Though the literature pertaining to their incidence and management is vast, it is limited by the retrospective study designs and smaller case series. Hence, we performed a prospective study in our institute to determine the incidence, surgical risk factors, complications and surgical outcomes in patients with unintended durotomy during spine surgery over a period of one year. The overall incidence in our study was 2.3% (44/1912). Revision spine surgeries in particular had a higher incidence of 16.6%. The average age of the study population was 51.6 years. The most common intraoperative surgical step associated with dural tear was removal of the lamina, and 50% of the injuries were during usage of kerrison rongeur. The most common location of the tear was paramedian location (20 patients) and the most common size of the tear was about 1 mm-5mm (31 patients). We observed that the dural repair techniques, placement of drain and prolonged post-operative bed rest didnot significantly affect the post-operative outcomes. One patient in our study developed persistent CSF leak, which was treated by subarachnoid lumbar drain placement. No patients developed pseudomeningocele or post-operative neurological worsening or re-exploration for dural repair. Wound complications were noted in 4 patients and treated by debridement and antibiotics. Based on our study, we have proposed a treatment algorithm for the management of dural tears in spine surgery.     

Hip fractures in Finland and Great Britain – a comparison of patient characteristics and outcomes

All hip fracture patients (age <50 years, pathological and subtrochanteric fractures excluded) were registered at admission to hospital and at 4 months (mortality up to 1 year) between 1989 and 1997 in Peterborough District Hospital (2083 patients) and Oulu University Hospital (1702 patients). The mean age at fracture was 80.3 years in Peterborough and 78.3 years in Oulu. Respectively, 69% and 62% of the patients had been living in their own homes, 50% and 54% had been able to walk alone unassisted. In Oulu, the patients were discharged after a mean stay of 7.1 days, most of them to health care centre hospitals (71%) and only 21% to their original place of residence. In Peterborough 81% were discharged to their original place of residence after a mean stay of 15.6 days. At 4 months, 54% were living at their own homes in Peterborough and 44% in Oulu. The overall mortality at 1 year was 27.1% in Peterborough and 24.9% in Oulu.     

Cranial nerve palsy following central neuraxial block in obstetrics – a review of the literature and analysis of 43 case reports

BackgroundCranial nerve palsy is a rarely reported complication of central neuraxial block in obstetrics. The aetiology is diverse and includes both decreased and increased intracranial pressure.MethodsMedline, CINAHL, and EMBASE databases were searched to identify cases of cranial nerve palsy following obstetric central neuraxial block. Possible aetiology, clinical symptoms and signs, treatment, and time to resolution were assessed.ResultsForty-one articles containing 43 case reports of cranial nerve palsy following obstetric central neuraxial block were identified. Four cranial nerve palsies were bilateral; the remainder being unilateral. The cranial nerves most commonly affected were the abducens (17 case reports) and facial (12 case reports) nerves. Epidural block was implicated in 25 cases. Classical post-dural puncture headache preceded cranial nerve palsy in 27 cases. Subdural haematomas were reported in six cases and cortical venous or transverse sinus thrombosis in one case. Epidural blood patch was administered for treatment of cranial nerve palsy in 17 cases. Thirty-five patients had complete resolution of symptoms but in eight the cranial nerve palsy was permanent. No case reports of olfactory, oculomotor, glossopharyngeal, accessory or hypoglossal nerve palsy were identified.ConclusionIntracranial hypotension is the most common aetiology of cranial nerve palsy after central neuraxial block in obstetrics. Neuroimaging is recommended in every case, to exclude other neurological causes. Epidural blood patch was the most utilised treatment for post-dural puncture cranial nerve palsy, but outcomes were variable. The majority of cranial nerve palsies resolved over the subsequent weeks and months.     

Changes in the incidence and treatment of distal radius fractures in adults – a 22-year nationwide register study of 276,145 fractures

IntroductionThe incidence of distal radius fractures (DRFs) is reported, with conflicting results. To ensure evidence-based practice, the variation in treatment over time should be monitored. Treatment in the elderly population is particularly interesting because newer guidelines find little indication for surgery. Our primary aim was to assess the incidence and treatment of DRFs in the adult population. Secondly, we assessed the treatment stratified on non-elderly (aged 18–64 years) and elderly (aged 65+ years) patients.MethodsThis is a population-based register study comprising all adult patients (i.e. aged over 18 years) with DRFs in the Danish National Patient Register from 1997 to 2018. Data were extracted using the ICD-10 code for DRF (DS52.5), and the incidence was calculated using data from Statistics Denmark. We defined a case as surgically treated if a relevant procedure was performed within three weeks of the DRF diagnosis. Nordic procedure codes were used to define surgical treatments as either plate (KNCJ65), external fixation (KNCJ25), k-wire (KNCJ45), or ‘other’ (KNCJ35,55,75,85,95).ResultsA total of 276,145 fractures were included, with an overall increase in DRFs of 31% during the study period. The overall incidence was 228/100,000/year, which increased by 20% during the study period. The increased incidence was especially notable among women and those aged 50–69 years. Surgical treatment steadily increased from 8% in 1997 to 22% in 2010, thereafter reaching a plateau at 24% in 2018. The surgical rate in the elderly group was as high as in the non-elderly group. In 1997, the treatment distribution of DRFs was as follows: 59% external fixation, 20% plate fixation, and 18% k-wire fixation. From 2007 and onwards, plating was the primary choice of surgery, and in 2018, 96% of patients were treated with a plate.ConclusionWe found a 31% increase in DRFs over a 22-year period, mostly driven by an increase in the size of the elderly population. The surgical rate increased markedly even in the elderly group. There is a lack of evidence on how beneficial surgery is for elderly patients, and similar surgical rate between the elderly and non-elderly calls for hospitals to re-evaluate their treatment strategies.     

Distal locking of short cephalomedullary nails decreases varus collapse in unstable intertrochanteric fractures – a biomechanical analysis

IntroductionPeritrochanteric fractures are a growing problem and complications relating to operative fixation of these fracture, including varus collapse and screw cutout, are common in elderly osteoporotic patients. We hypothesize that unlocked nails will demonstrate increased varus collapse and inferior construct stiffness in specimens with increased diaphyseal medullary diameter.Materials and methodsSixteen non-cadaveric osteoporotic biomechanical femur specimens were utilized in this study, with eight specimens having an artificially large femoral canal to represent Dorr C femurs. All femurs were instrumented with a short cephalomedullary nail with and without distal cross-lock screw fixation and had an unstable intertrochanteric fracture created in a repeatable pattern. Specimens underwent cyclic compression to a maximal load of 1000N with segmental motion quantified through the use of visual tracking markers. Statistical comparisons were performed using one-way ANOVA with Tukey post-hoc analysis to determine differences between specific groups. Significance was defined as p<0.05.ResultsUnlocked short cephalomedullary nails showed increased varus collapse due to motion of the nail within the femoral canal in capacious femoral canals compared with narrow femoral canals and distally cross-locked nails. The coronal deformation of the wide canal unlocked group (17.9 ^o±2.6^o) was significantly greater in the varus direction than any other fixation under compressive load of 1000N. There was no significant difference in varus angulation between the wide canal or narrow canal locked groups (11.1^o±8.7^o vs. 8.2^o±1.7^o respectively, p=0.267). The narrow canal unlocked group (13.7^o±2.4^o) showed significantly greater varus angulation than the narrow canal locked (p=0.015). The wide canal unlocked group showed significantly greater varus angulation than the wide canal locked group (p=0.003). Motion between the femoral shaft and the cephalomedullary nail (toggling of the nail within the shaft) was significantly greater in narrow or wide canal unlocked specimens, 7.94^o±2.13^o and 10.2^o±1.7^o respectively, than in the narrow or wide canal locked specimens, 2.4^o±0.2^o and 4.2^o±0.5^o respectively (p<0.05)ConclusionUnlocked short intramedullary fixation for unstable peritrochanteric fractures results in increased varus collapse under axial compression. This study supports the use of distal cross-locking of short intramedullary fixation for unstable peritrochanteric fractures in patients with capacious femoral canals secondary to osteoporosis who might otherwise be as risk for varus collapse, device failure, and malunion.     

Femoral shaft fractures in eldery patients – An epidemiological risk analysis of incidence,mortality and complications

ObjectivesThis work aimed at answering the following research questions: (1) What is the incidence of femoral shaft fractures in the geriatric population in the U.S.? (2) What is the rate of mortality, mechanical complications, nonunion and infection, and what are the associated risk factors?Study design and settingIn this cross-sectional study, femoral shaft fractures occurred between January 1, 2009, and December 31, 2019, were identified from Medicare records. Rates of mortality, nonunion, infection, and mechanical complications were calculated with the Kaplan-Meier method with Fine and Gray sub-distribution adaptation. Semiparametric Cox regression was applied with twenty-three covariates to determine risk factors.ResultsBetween 2009 through 2019 the incidence of femoral shaft fractures decreased by 12.07% to 40.8/100,000 inhabitants (p = 0.549). The 5-year mortality risk was 58.5%. Male sex, age over 75 years, chronic obstructive pulmonary disease, cerebrovascular disease, chronic kidney disease, congestive heart failure, diabetes mellitus, osteoporosis, tobacco dependence, and lower median household income were significant risk factors. The infection rate was 2.22% [95%CI: 1.90–2.58] and the union failure rate 2.52% [95%CI: 2.17–2.92] after 24 months.ConclusionAn early assessment of individual patient risk factors may be beneficial in the care and treatment of patients with these fractures.     

Evolution in the management of Hirschsprung��s disease in the UK and Ireland: a national survey of practice revisited

INTRODUCTION

The management of Hirschsprung’s disease continues to evolve. This questionnaire survey aimed to determine current surgical management strategies for Hirschsprung’s disease in Britain.

SUBJECTS AND METHODS

The survey was sent electronically to all British paediatric surgeons. Initial questions explored individual experience and regional service provision. Additional questions, reserved for surgeons who perform definitive Hirschsprung’s disease surgery, addressed specific clinical scenarios.

RESULTS

Surveys were sent to 142 surgeons yielding 85 responses. After exclusions, 64 surveys from 21 centres were analysed. Forty-seven respondents worked in centres with designated ‘Hirschsprung’s disease surgeons’. Forty respondents perform definitive Hirschsprung’s disease surgery. In a well neonate with left-sided Hirschsprung’s disease, 34 of 40 surgeons favour primary pull-through following bowel decompression with rectal washouts; 35 of 40 surgeons aim to perform definitive surgery at less than 3 months of age, with 17 favouring laparoscopic-assisted Soave–Boley and 15 favouring an open Duhamel pull-through. Of the 40 surgeons, 36 use a staged approach to right-sided/total colonic Hirschsprung’s disease with 23 favouring a Duhamel or Long Duhamel pull-through.

CONCLUSIONS

The primary pull-through, using an open Duhamel or laparoscopic-assisted Soave–Boley technique, during the first 3 months of life, has become the operative strategy of choice in rectosigmoid Hirschsprung’s disease in Britain. Marked variation in practice remains for right-sided Hirschsprung’s disease.     

The role of specialist physiotherapy in a pain management clinic – traditional and novel approaches

There is no doubt that coronavirus disease (COVID-19) has had a drastically negative impact on the NHS, as well as many other public services, individuals and families. The role of physiotherapy in managing chronic pain is challenging; even more so with the added burden of COVID-19. As COVID-19 cases increased many non-urgent outpatient services were suspended: This district general hospital continued to offer some appointments, albeit limited, but were they beneficial? This article not only considers the multidisciplinary approach to manage chronic pain; focusing on the bio-psycho-social model, which incorporates a variety of specialities within a pain clinic but also the impact of COVID-19. It considers both the clinicians' and patients' experiences respectively of offering, and receiving, key physiotherapy treatments such as patient education, patient empowerment, exercise and function; how these were modified, sometimes with digital support. It gives some insight into the differing patient responses and attitudes such as patients who fear exercise; those who expected physiotherapy to be a ‘hands-on treatment’ and the challenges of ‘remote’ patient supervision. Alternatives to educational groups are described and the patients' responses to them. Other treatments such as phased activities, goal setting, cognitive functional therapy, desensitization, mirror therapy, virtual reality, yoga, tai chi, and acceptance and commitment therapy are briefly outlined.     

Clinical outcomes and complications of titanium versus stainless steel elastic nail in management of paediatric femoral fractures—a systematic review

Femoral shaft fractures in children account for approximately 1.6% of all fractures. These fractures can be treated both operatively and non-operatively. Surgical fixation is more common in the age group above 6 years. Elastic intramedullary nails have become the most popular surgical modality of treatment over the last few decades. However, there is continuous debate about which type of elastic nails (titanium and stainless steel) provides better clinical outcomes with less complication. The main purpose of this study was to systematically search for and critically appraise articles comparing clinical outcomes and complications of titanium elastic nail system (TENS) and stainless steel elastic nail system (SSENS) in management of femoral fractures in the paediatric age group. A comprehensive search of MEDLINE, EMBASE, and Cochrane library databases was performed using specific search terms and limits. Applying strict eligibility criteria, the identified studies were screened. Five studies were identified and reviewed. All of the identified studies were non-randomised comparative studies apart from one randomised controlled study. Studies provide contradictory evidence with regard to time to fracture union and time to full weight bearing. Only one study commented on time to nail removal and found that it is shorter in the TENS group. Two studies showed significantly higher rate of malunion in the TENS group, whereas the rest showed no difference. There was no difference in the rates of delayed union or infection between the two groups and no consistent difference in the rates of skin irritation. Three studies compared Flynn’s outcome score and found no difference apart from one study which found better scores in the SSENS group. There is no consistent evidence to indicate the advantage of one type of elastic nails over the other in management of paediatric femoral shaft fractures; however, the overall trend is in favour of SSENS especially being cheaper than TENS. Critical appraisal of the studies identified significant methodological deficiencies, and further prospective randomised trials are recommended for more potent evidence.