Challenges of conducting a randomised placebo-controlled trial of spinal surgery: the SUcceSS trial of lumbar spine decompression.

Although placebo-controlled trials are considered the gold standard for evaluating the efficacy of healthcare interventions, they can be perceived to be controversial and challenging to conduct for surgical treatments. The SUcceSS trial is the first placebo-controlled trial of lumbar decompression surgery for symptomatic lumbar canal stenosis. The SUcceSS trial has experienced common issues affecting the implementation of randomised placebo-controlled surgery trials, accentuated by the COVID-19 pandemic. Using the SUcceSS trial as an example, we discuss key challenges and mitigation strategies specific to the conduct of a randomised placebo-controlled surgical trial. Overall, the key lessons learned were (i) involving key stakeholders early and throughout the trial design phase may increase clinician and patient willingness to participate in a placebo-controlled trial of surgical interventions, (ii) additional resources (e.g. budget, staff time) are likely required to successfully operationalise trials of this nature, (iii) the level of placebo fidelity, timing of randomisation relative to intervention delivery, and nuances of the surgical procedure under investigation should be considered carefully. Findings are based on one example of a placebo-controlled surgical trial; however, researchers may benefit from employing or building from the strategies described and lessons learned when designing or implementing future trials of this nature.

Acute assessment of spinal cord injury in New South Wales: A retrospective study of current practice in two spinal cord injury referral centers.

INTRODUCTION: Interventions provided in the early phases after spinal cord injury (SCI) may improve neurological recovery and provide for best possible functional outcomes. Knowing this relies on early and clear documentation of the level and grade of the spinal cord injury. Guidelines advocate for early documentation of neurological status within 72 h of injury to allow early prognostication and to help guide initial management. It is unclear whether this is current practice in New South Wales (NSW). METHODS: Patients with acute SCI who were admitted to two SCI referral centers during 2018-2019 in NSW were included. Data relating to documentation of neurological status, timing of imaging, surgery and transfer to spinal cord injury center were collected and summarized using descriptive statistics. RESULTS: Only 18 percent of patients had an acceptable neurological examination according to the International Standards for Classification of Spinal Cord Injury (ISNCSCI) within 72 h of injury (either not done, or unable to determine the neurological level of injury). At the first neurological examination, the neurological level of injury and grade was unable to be determined in 26.8% of patients and 29.9% of patients respectively. At discharge from acute care and transfer to rehabilitation, the neurological level was undetermined in 28.9% of patients and grade undetermined in 26.8%. ISNCSCI examination was most commonly performed by spinal rehabilitation doctors after patients were discharged from the intensive care unit (ICU). CONCLUSIONS: Documentation of neurological level and grade of SCI within 72 h of injury is not being performed in the large majority of this cohort, which may impede evaluation of neurological improvement in response to acute treatment, and hinder prognostication.

Safety and Efficacy of Riluzole in Acute Spinal Cord Injury Study (RISCIS): A Multi-Center, Randomized, Placebo-Controlled, Double-Blinded Trial.

Riluzole is a sodium-glutamate antagonist that attenuates neurodegeneration in amyotrophic lateral sclerosis (ALS). It has shown favorable results in promoting recovery in pre-clinical models of traumatic spinal cord injury (tSCI) and in early phase clinical trials. This study aimed to evaluate the efficacy and safety of riluzole in acute cervical tSCI. An international, multi-center, prospective, randomized, double-blinded, placebo-controlled, adaptive, Phase III trial (NCT01597518) was undertaken. Patients with American Spinal Injury Association Impairment Scale (AIS) A-C, cervical (C4-C8) tSCI, and <12 h from injury were randomized to receive either riluzole, at an oral dose of 100 mg twice per day (BID) for the first 24 h followed by 50 mg BID for the following 13 days, or placebo. The primary efficacy end-point was change in Upper Extremity Motor (UEM) scores at 180 days. The primary efficacy analyses were conducted on an intention to treat (ITT) and completed cases (CC) basis. The study was powered at a planned enrolment of 351 patients. The trial began in October 2013 and was halted by the sponsor on May 2020 (and terminated in April 2021) in the face of the global COVID-19 pandemic. One hundred ninety-three patients (54.9% of the pre-planned enrolment) were randomized with a follow-up rate of 82.7% at 180 days. At 180 days, in the CC population the riluzole-treated patients compared with placebo had a mean gain of 1.76 UEM scores (95% confidence interval: -2.54-6.06) and 2.86 total motor scores (CI: -6.79-12.52). No drug-related serious adverse events were associated with the use of riluzole. Additional pre-planned sensitivity analyses revealed that in the AIS C population, riluzole was associated with significant improvement in total motor scores (estimate: standard error [SE] 8.0; CI 1.5-14.4) and upper extremity motor scores (SE 13.8; CI 3.1-24.5) at 6 months. AIS B patients had higher reported independence, measured by the Spinal Cord Independence Measure score (45.3 vs. 27.3; d: 18.0 CI: -1.7-38.0) and change in mental health scores, measured by the Short Form 36 mental health domain (2.01 vs. -11.58; d: 13.2 CI: 1.2-24.8) at 180 days. AIS A patients who received riluzole had a higher average gain in neurological levels at 6 months compared with placebo (mean 0.50 levels gained vs. 0.12 in placebo; d: 0.38, CI: -0.2-0.9). The primary analysis did not achieve the predetermined end-point of efficacy for riluzole, likely related to insufficient power. However, on pre-planned secondary analyses, all subgroups of cervical SCI subjects (AIS grades A, B and C) treated with riluzole showed significant gains in functional recovery. The results of this trial may warrant further investigation to extend these findings. Moreover, guideline development groups may wish to assess the possible clinical relevance of the secondary outcome analyses, in light of the fact that SCI is an uncommon orphan disorder without an accepted neuroprotective treatment.

Design and evaluation of 3D-printed Sr-HT-Gahnite bioceramic for FDA regulatory submission: A Good Laboratory Practice sheep study.

There is an unmet clinical need for a spinal fusion implant material that recapitulates the biological and mechanical performance of natural bone. We have developed a bioceramic, Sr-HT-Gahnite, which has been identified as a potential fusion device material. This material has the capacity to transform the future of the global interbody devices market, with follow on social, economic, and environmental benefits, rooted in its remarkable combination of mechanical properties and bioactivity. In this study, and in line with FDA requirements, the in vivo preclinical systemic biological safety of a Sr-HT-Gahnite interbody fusion device is assessed over 26 weeks in sheep under good laboratory practice (GLP). Following the in-life phase, animals are assessed for systemic biological effects via blood haematology and clinical biochemistry, strontium dosage analysis in the blood and wool, and histopathology examination of the distant organs including adrenals, brain, heart, kidneys, liver, lungs and bronchi, skeletal muscle, spinal nerves close to the implanted sites, ovaries, and draining lymph nodes. Our results show that no major changes in blood haematology or biochemistry parameters are observed, no systemic distribution of strontium to the blood and wool, and no macroscopic or histopathological abnormalities in the distant organs when Sr-HT-Gahnite was implanted, compared to baseline and control values. Together, these results indicate the systemic safety of the Sr-HT-Gahnite interbody fusion device. The results of this study extend to the systemic safety of other Sr-HT-Gahnite implanted medical devices in contact with bone or tissue, of similar size and manufactured using the described processes. STATEMENT OF SIGNIFICANCE: This paper is considered original and innovative as it is the first that thoroughly reports the systemic biological safety of previously undescribed bioceramic material, Sr-HT-Gahnite. The study has been performed under good laboratory practice, in line with FDA requirements for assessment of a new interbody fusion device, making the results broadly applicable to the translation of sheep models to the human cervical spine; and also the translation of Sr-HT-Gahnite as a biomaterial for use in additional applications. We expect this study to be of broad interest to the readership of Acta Biomaterilia. Its findings are directly applicable to researchers and clinicians working in bone repair and the development of synthetic biomaterials.

How much change in symptoms do spinal surgeons expect following lumbar decompression and microdiscectomy?

The study aimed to determine how much change in neurogenic claudication spinal surgeons expect in patients following lumbar decompression for lumbar spine stenosis (LSS), and radicular leg pain following microdiscectomy. Secondary aims were to identify surgeons' preferences regarding surgical techniques for lumbar decompression, and their rating of the quality of current evidence for lumbar decompression. All Australian spine surgeons were invited, of whom 71 completed the survey (31% response rate). Only registered spinal surgeons were included. The online survey, administered using REDCap, included 4 sections: demographics and background; expected change in symptoms on a +/- 100% scale (-100% worst, 0% no change and 100% best possible); surgical preference; and rating of current evidence for lumbar decompression compared with other treatments. There were 71 complete responses, 76% were neurosurgeons (N = 54), predominantly male (96%; N = 68). On average, surgeons expected an 86% (median: 87%, inter-quartile range (IQR): 80%, 91%) improvement in neurogenic claudication following lumbar decompression for LSS and 89% (median: 91%, IQR: 85%, 95%) improvement in radicular pain following microdiscectomy. A multiple linear regression found no surgeon characteristics were associated with expected change following surgery. The preferred surgical technique for LSS was full laminectomy (58%; N = 41). Thirty-five percent of surgeons accurately rated the evidence supporting the superiority of lumbar decompression compared with non-surgical care for LSS as low quality. Spine surgeons expect large symptom improvements following lumbar decompression and microdiscectomy. Understanding of the current evidence was higher for lumbar decompression with fusion, than for decompression alone for LSS.

A geospatial examination of specialist care accessibility and impact on health outcomes for patients with acute traumatic spinal cord injury in New South Wales, Australia: a population record linkage study.

BACKGROUND: Timely treatment is essential for achieving optimal outcomes after traumatic spinal cord injury (TSCI), and expeditious transfer to a specialist spinal cord injury unit (SCIU) is recommended within 24 h from injury. Previous research in New South Wales (NSW) found only 57% of TSCI patients were admitted to SCIU for acute post-injury care; 73% transferred within 24 h from injury. We evaluated pre-hospital and inter-hospital transfer practices to better understand the post-injury care pathways impact on patient outcomes and highlight areas in the health service pathway that may benefit from improvement. METHODS: This record linkage study included administrative pre-hospital (Ambulance), admissions (Admitted Patients) and costs data obtained from the Centre for Health Record Linkage, NSW. All patients aged ≥16 years with incident TSCI in NSW (2013-2016) were included. We investigated impacts of geographical disparities on pre-hospital and inter-hospital transport decisions from injury location using geospatial methods. Outcomes assessed included time to SCIU, surgery and the impact of these variables on the experience of inpatient complications. RESULTS: Inclusion criteria identified 316 patients, geospatial analysis showed that over half (53%, n = 168) of all patients were injured within 60 min road travel of a SCIU, yet only 28.6% (n = 48) were directly transferred to a SCIU. Patients were more likely to experience direct transfer to a SCIU without comorbid trauma (p < 0.01) but higher ICISS (p < 0.001), cervical injury (p < 0.01), and transferred by air-ambulance (p < 0.01). Indirect transfer to SCIU was more likely with two or more additional traumatic injuries (p < 0.01) or incomplete injury (p < 0.01). Patients not admitted to SCIU at all were older (p = 0.05) with lower levels of injury (p < 0.01). Direct transfers received earlier operative intervention (median (IQR) 12.9(7.9) hours), compared with patients transferred indirectly to SCIU (median (IQR) 19.5(18.9) hours), and had lower risk of complications (OR 3.2 v 1.4, p < 0.001). Complications included pressure injury, deep vein thrombosis, urinary infection, among others. CONCLUSIONS: Getting patients with acute TSCI patients to the right place at the right time is dependent on numerous factors; some are still being triaged directly to non-trauma services which delays specialist and surgical care and increases complication risks. The higher rates of complication following delayed transfer to a SCIU should motivate health service policy makers to investigate reasons for this practice and consent to improvement strategies. More stringent adherence to recommended guidelines would prioritise direct SCIU transfer for patients injured within 60 min radius, enabling the benefits of specialised care.

Identifying Predictors of Higher Acute Care Costs for Patients With Traumatic Spinal Cord Injury and Modeling Acute Care Pathway Redesign: A Record Linkage Study.

STUDY DESIGN: Record linkage study using healthcare utilization and costs data. OBJECTIVE: To identify predictors of higher acute-care treatment costs and length of stay for patients with traumatic spinal cord injury (TSCI). SUMMARY OF BACKGROUND DATA: There are few current or population-based estimates of acute hospitalization costs, length of stay, and other outcomes for people with TSCI, on which to base future planning for specialist SCI health care services. METHODS: Record linkage study using healthcare utilization and costs data; all patients aged more than or equal to 16 years with incident TSCI in the Australian state of New South Wales (June 2013-June 2016). Generalized Linear Model regression to identify predictors of higher acute care treatment costs for patients with TSCI. Scenario analysis quantified the proportionate cost impacts of patient pathway modification. RESULTS: Five hundred thirty-four incident cases of TSCI (74% male). Total cost of all acute index episodes approximately AUD$40.5 (95% confidence interval [CI] ±4.5) million; median cost per patient was AUD$45,473 (Interquartile Range: $15,535-$94,612). Patient pathways varied; acute care was less costly for patients admitted directly to a specialist spinal cord injury unit (SCIU) compared with indirect transfer within 24 hours. Over half (53%) of all patients experienced at least one complication during acute admission; their care was less costly if they had been admitted directly to SCIU. Scenario analysis demonstrated that a reduction of indirect transfers to SCIU by 10% yielded overall cost savings of AUD$3.1 million; an average per patient saving of AUD$5,861. CONCLUSION: Direct transfer to SCIU for patients with acute TSCI resulted in lower treatment costs, shorter length of stay, and less costly complications. Modeling showed that optimizing patient-care pathways can result in significant acute-care cost savings. Reducing potentially preventable complications would further reduce costs and improve longer-term patient outcomes. LEVEL OF EVIDENCE: 3.

SUcceSS, SUrgery for Spinal Stenosis: protocol of a randomised, placebo-controlled trial.

INTRODUCTION: Central lumbar spinal stenosis (LSS) is a common cause of pain, reduced function and quality of life in older adults. Current management of LSS includes surgery to decompress the spinal canal and alleviate symptoms. However, evidence supporting surgical decompression derives from unblinded randomised trials with high cross-over rates or cohort studies showing modest benefits. This protocol describes the design of the SUrgery for Spinal Stenosis (SUcceSS) trial -the first randomised placebo-controlled trial of decompressive surgery for symptomatic LSS. METHODS AND ANALYSIS: SUcceSS will be a prospectively registered, randomised placebo-controlled trial of decompressive spinal surgery. 160 eligible participants (80 participants/group) with symptomatic LSS will be randomised to either surgical spinal decompression or placebo surgical intervention. The placebo surgical intervention is identical to surgical decompression in all other ways with the exception of the removal of any bone or ligament. All participants and assessors will be blinded to treatment allocation. Outcomes will be assessed at baseline and at 3, 6, 12 and 24 months. The coprimary outcomes will be function measured with the Oswestry Disability Index and the proportion of participants who have meaningfully improved their walking capacity at 3 months postrandomisation. Secondary outcomes include back pain intensity, lower limb pain intensity, disability, quality of life, anxiety and depression, neurogenic claudication score, perceived recovery, treatment satisfaction, adverse events, reoperation rate and rehospitalisation rate. Those who decline to be randomised will be invited to participate in a parallel observational cohort. Data analysis will be blinded and by intention to treat. A trial-based cost-effectiveness analysis will determine the potential incremental cost per quality-adjusted life year gained. ETHICS AND DISSEMINATION: Ethics approval has been granted by the NSW Health (reference:17/247/POWH/601) and the Monash University (reference: 12371) Human Research Ethics Committees. Dissemination of results will be via journal articles and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: ACTRN12617000884303; Pre-results.

Emergency and acute care management of traumatic spinal cord injury: a survey of current practice among senior clinicians across Australia.

BACKGROUND: To describe pre-hospital, emergency department and acute care assessment and management practices of senior clinicians for patients with acute traumatic spinal cord injury (TSCI) across Australia; and to describe clinical practice variation. METHODS: We used a descriptive, cross-sectional study design to survey senior clinicians (greater than 10 years practice in this field) caring for patients with acute TSCI. The assessment, management and referral practices of prehospital, emergency department/trauma and surgical expert clinicians, across prehospital, early hospital care, diagnostic imaging and haemodynamic management were surveyed. RESULTS: We invited 95 eligible senior clinicians; the response rate was 75%. Survey findings demonstrated overall lack of awareness or consistent use of evidence based published guidelines; many clinicians following 'locally written' or 'no particular' guideline. Practitioners were conflicted across multiple areas including patient assessment and diagnosis, treatment and transport decisions. Reported spinal immobilisation practices differed substantially, as did target setting for blood pressure; the majority of clinicians actively monitored risk of respiratory deterioration. Specialist care consult and specialist service bed availability was reported as problematic by more than one third of clinicians. CONCLUSIONS: Unwarranted clinical practice variation is known to contribute to different health outcomes for patients with similar etiologies. Clinical practice guidelines offer evidence based, best practice standards, however are only effective if adopted throughout the healthcare system. Wide variability in acute care practices, pathways and timing to specialist centres for TSCI was evidenced by this survey despite seniority among clinicians. This devastating injury requires prompt, consistent, evidence based care from the moment of first responder. Improved outcomes for patients with TSCI would be more likely with standardised care across pre-hospital, emergency and acute care phases of care.

Lumbar spine fusion: what is the evidence?

Lumbar spine fusion is a common procedure associated with a high cost burden and risk of serious complications. We aimed to summarise systematic reviews on the effectiveness of lumbar spine fusion for most diagnoses. We found no high-quality systematic reviews and the risk of bias of the randomised controlled trials in the reviews was generally high. The available evidence does not support a benefit from spine fusion compared to non-operative alternatives for back pain associated with degeneration. The available evidence does not support a clinical benefit from spine fusion compared to non-operative treatment or stabilisation without fusion for thoracolumbar burst fractures. Benefits of spine fusion compared to non-operative treatment for isthmic spondylolisthesis are unclear (one trial at high risk of bias). Surgical intervention for metastatic carcinoma of the spine associated with spinal cord compromise improves mobility and neurological outcome (based on a single trial). Better evidence is required to determine more accurately the effectiveness of spine fusion surgery for all indications. Patients contemplating spinal fusion should be fully informed about the evidence base for their particular problem, including the relative potential benefits and harms of fusion compared with non-operative treatments.

Health outcomes and costs of acute traumatic spinal injury in New South Wales, Australia.

BACKGROUND CONTEXT: Traumatic spinal injuries are often associated with both long-term disability, higher frequency of hospital readmissions, and high medical costs for individuals of all ages. Age differences in terms of injury profile and health outcomes among those who sustain a spinal cord injury have been identified. However, factors that may influence health outcomes among those with a spinal injury have not been extensively examined at a population level. PURPOSE: The present study aims to describe the characteristics of traumatic spinal injury, identify factors predictive of mortality, and estimate the cost of hospital treatment for younger and older people. STUDY DESIGN/SETTING: This is a population-based retrospective epidemiological study using linked hospitalization and mortality records during January 1, 2010 to June 30, 2014 in New South Wales, Australia. PATIENT SAMPLE: The present study included 13,429 hospitalizations. OUTCOME MEASURES: Mortality within 30 and 90 days of hospitalization, hospital length of stay (LOS), and hospitalization costs were determined. METHODS: Hospitalizations with a principal diagnosis of spinal cord injury or spinal fractures were used to identify traumatic spinal injuries. Age-standardized incidence rates were calculated and negative binomial regression was used to examine statistical significant changes over time. Cox proportional hazard regression was used to examine the effect of risk factors on survival at 90 days. RESULTS: There were 13,429 hospitalizations, with 52.4% of individuals aged ≥65 years. The hospitalization rates for individuals aged ≤64 and ≥65 years were both estimated to significantly increase per year by 3.3% (95% confidence interval [CI] 0.97-5.79, p<.006) and 3.3% (95% CI 1.02-5.71, p=.005), respectively. For individuals aged ≥65 years, there were a higher proportion of women injured, comorbid conditions, injuries after a fall in the home or aged care facility, a longer hospital LOS, unplanned hospital admissions, and deaths than individual aged ≤64 years. The average cost per index hospitalization was AUD$23,808 for individuals aged ≤64 years and AUD$31,187 for individuals aged ≥65 years with a total estimated cost of AUD$371 million. Mortality risk at 90 days was increased for individuals who had one or more comorbidities, a higher injury severity score, and if their injury occurred in the home or an aged care facility. CONCLUSIONS: Spinal injury represents a substantial cost and results in debilitating injuries, particularly for older individuals. Spinal injury prevention efforts for older people should focus on the implementation of fall injury prevention, whereas for younger individuals, prevention measures should target road safety.

Image-Guided Lateral Mass Osteotomy for En Bloc Resection of Cervical Ewing Sarcoma: A Technical Note.

BACKGROUND: En bloc resection of Ewing sarcoma in the cervical spine according to Enneking's principles is technically challenging owing to the proximity of important neurovascular structures, the complex local anatomy, and the biomechanical instability of radical resection. The rarity of Ewing sarcoma and variability of its presentation justifies ongoing exploration and compilation of the surgical nuances and subtleties of en bloc resection in the cervical spine. CASE DESCRIPTION: We present a 34-year-old male with Ewing sarcoma of the neck who underwent successful en bloc resection using a novel technique of splitting the laminae and osteomizing the lateral masses under imaging guidance. CONCLUSIONS: This novel and successful approach of en bloc resection in the cervical spine can add to the spinal surgeon's repertoire when dealing with complex cervical tumor masses.

Improving care standards for patients with spinal trauma combining a modified e-Delphi process and stakeholder interviews: a study protocol.

INTRODUCTION: Around 300 people sustain a new traumatic spinal cord injury (TSCI) in Australia each year; a relatively low incidence injury with extremely high long-term associated costs. Care standards are inconsistent nationally, lacking in consensus across important components of care such as prehospital spinal immobilisation, timing of surgery and timeliness of transfer to specialist services. This study aims to develop 'expertly defined' and agreed standards of care across the majority of disciplines involved for these patients. METHODS AND ANALYSIS: A modified e-Delphi process will be used to gain consensus for best practice across specific clinical early care areas for the patient with TSCI; invited participants will include clinicians across Australia with relevant and significant expertise. A rapid literature review will identify available evidence, including any current guidelines from 2005 to 2015. Level and strength of evidence identified, including areas of contention, will be used to formulate the first round survey questions and statements. Participants will undertake 2-3 online survey rounds, responding anonymously to questionnaires regarding care practices and indicating their agreement or otherwise with practice standard statements. Relevant key stakeholders, including patients, will also be interviewed face to face. ETHICS AND DISSEMINATION: Ethics approval for this study was obtained by the NSW Population & Health Services Research Ethics Committee on 14 January 2016 (HREC/12/CIPHS/74). Seeking comprehensive understanding of how the variation in early care pathways and treatment can be addressed to achieve optimal patient outcomes and economic costs; the overall aim is the agreement to a consistent approach to the triage, treatment, transport and definitive care of acute TSCI victims. The agreed practice standards of care will inform the development of a Clinical Pathway with practice change strategies for implementation. These standards will offer a benchmark for state-wide and potentially national policy.

Incidence, circumstances, treatment and outcome of high-level cervical spinal fracture without associated spinal cord injury in New South Wales, Australia over a 12 year period.

BACKGROUND: No Australian population-based studies have examined temporal trends in the incidence of fracture of the first or second cervical vertebra (C1 or C2 fractures), their aetiology, treatment and outcome for younger (15-64 years) compared to older (65+ years) individuals. The aim of this research is to examine the circumstances, treatment and outcomes including mortality for C1 or C2 fractures without associated spinal cord injury by age group in New South Wales (NSW), Australia. METHOD: A retrospective review of C1 or C2 vertebra fractures in individuals aged 15 years and over in the NSW Admitted Patient Data Collection from 1 July 1998 to 30 June 2010. Direct age standardised admission rates were calculated by cervical fracture type and by age group. Negative binomial regression was used to examine the statistical significance of changes in trend over time of hospitalised cervical fractures by age group. RESULTS: The annual rate of hospitalised C1 and C2 fractures without associated spinal cord injury for individuals aged 15 years and over in NSW was 2.3 per 100,000 population, with the rate estimated to increase by 5.3% each year. Those aged 85+ years had the highest rates of hospitalisation. For those aged 15-64 years, road trauma was the most common mechanism of injury, while for those aged 65+ years, a fall was the dominant mechanism of injury. The in-hospital mortality for individuals aged 65+ years was 11.8% compared to 0.7% for those aged 15-64 years. CONCLUSIONS: This study identified an estimated increasing trend in C1 and C2 fractures over time, particularly for older individuals. While younger individuals are commonly injured in road traffic accidents, older individuals are predominantly injured following a fall. Injury prevention strategies should be targeted to the different age groups and injury mechanisms. Implementation of effective falls prevention strategies is likely to reduce these injuries in older people whilst road and vehicle safety including vehicle rollover protection standards may improve rates in younger people.

Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union.

BACKGROUND: Hyperbaric oxygen therapy (HBOT) consists of intermittently administering 100% oxygen at pressures greater than one atmosphere absolute (ATA) in a pressure vessel. This technology has been used to treat a variety of diseases and has been described as helping patients who have delayed healing or established non-union of bony fractures. This is an update of a Cochrane Review first published in 2005, and previously updated in 2008. OBJECTIVES: The aim of this review is to assess the evidence for the benefit of hyperbaric oxygen treatment (HBOT) for the treatment of delayed bony healing and established non-union of bony fractures. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (July 2012), the Cochrane Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 7), MEDLINE (1946 to July Week 1 2012), EMBASE (1974 to 2012 July 16), CINAHL (1937 to 17 July 2012), the Database of Randomised Controlled Trials in Hyperbaric Medicine (accessed July 2012), the WHO International Clinical Trials Registry Platform (17 July 2012) and reference lists of articles. SELECTION CRITERIA: We aimed to include all randomised controlled trials comparing the clinical effects of HBOT with no HBOT (no treatment or sham) for healing of bony fractures and fracture non-unions. DATA COLLECTION AND ANALYSIS: Two review authors independently screened electronic search results, and all three authors independently performed study selection. We planned independent data collection and risk of bias assessment by two authors using standardised forms. MAIN RESULTS: No trials met the inclusion criteria. In this update, we identified three ongoing randomised controlled trials. Among the eight excluded studies were three randomised trials comparing HBOT with no treatment that included patients with fractures. One of these trials had been abandoned and the other two did not report on fracture healing outcomes. AUTHORS' CONCLUSIONS: This systematic review failed to locate any relevant clinical evidence to support or refute the effectiveness of HBOT for the management of delayed union or established non-union of bony fractures. Good quality clinical trials are needed to define the role, if any, of HBOT in the treatment of these injuries. There are three randomised controlled trials underway and we anticipate these will help provide some relevant clinical evidence to address this issue in the future.

Reconstruction versus no reconstruction of iliac crest defects following harvest for spinal fusion: a systematic review: A review.

OBJECT: Autologous bone from the iliac crest is commonly used for spinal fusion. However, its use is associated with significant donor site morbidity, especially pain. Reconstructive procedures of the iatrogenic defect have been investigated as a technique to alleviate these symptoms. The goal of this study was to assess the effects of reconstruction versus no reconstruction following iliac crest harvest in adults undergoing spine surgery. METHODS: The authors searched the Cochrane Central Register of Controlled Trials (The Cochrane Library 2011, Issue 4); MEDLINE (1948-Oct 2011); EMBASE (1947-Oct 2011); and the reference lists of articles. Randomized controlled trials (RCTs) or nonrandomized controlled trials (NRCTs) were included in the study. Two independent reviewers selected the studies, extracted data using a standardized collection form, and assessed for risk of bias. RESULTS: Three RCTs (96 patients) and 2 NRCTs (82 patients) were included. These had a moderate to high risk of bias. The results suggest that iliac crest reconstruction may be useful in reducing postoperative pain, minimizing functional disability, and improving cosmesis. No pattern of other clinical, radiological, or resource outcomes was identified. CONCLUSIONS: Although the available evidence is suboptimal, this systematic review supports the notion that iliac crest reconstruction following harvest for spinal fusion may reduce postoperative pain, minimize functional disability, and improve cosmesis.

WITHDRAWN: Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union.

BACKGROUND: Hyperbaric oxygen therapy (HBOT) consists of intermittently administering 100% oxygen at pressures greater than one atmosphere absolute (ATA) in a pressure vessel. This technology has been used to treat a variety of diseases and has been described as helping patients who have delayed healing or established non-union of bony fractures. OBJECTIVES: The aim of this review was to assess the evidence for the benefit of hyperbaric oxygen treatment (HBOT) for the treatment of delayed bony healing and established non-union of bony fractures. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (April 2008), the Cochrane Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2008), MEDLINE (OVID 1966 to April week 3, 2008), CINAHL (OVID 1982 to April week 3, 2008), EMBASE (OVID 1980 to week 17 2008), the locally developed Database of Randomised Controlled Trials in Hyperbaric Medicine (available at www.hboevidence.com) from inception to May 2008, and reference lists of articles. SELECTION CRITERIA: We aimed to include all randomised controlled trials that compared the effect of HBOT with no HBOT (no treatment or sham). DATA COLLECTION AND ANALYSIS: We planned independent data collection by two authors using standardised forms. MAIN RESULTS: No trials met the inclusion criteria. We excluded one trial that compared HBOT with no treatment because no clinical outcomes were reported. AUTHORS' CONCLUSIONS: This systematic review failed to locate any relevant clinical evidence to support or refute the effectiveness of HBOT for the management of delayed union or established non-union of bony fractures. Good quality clinical trials are needed to define the role, if any, of HBOT in the treatment of these injuries.

Cauda equina syndrome post-caesarean section.

Cauda equina syndrome is rarely associated with pregnancy, with few cases reported in the literature. The majority of cases describe antenatal presentations, with only one case manifesting post-partum, three weeks after a normal vaginal delivery. We outline a case of cauda equina syndrome following caesarean section in a patient with known lumbar disc disease, and discuss the contribution of the mode of delivery and anaesthesia as precipitants of disc herniation causing cauda equina compression. We conclude that vigilance, particularly in the post-partum setting, be attributed towards the neurological surveillance of women with known disc disease.

Multiaxial pedicle screw designs: static and dynamic mechanical testing.

STUDY DESIGN: Randomized investigation of multiaxial pedicle screw mechanical properties. OBJECTIVES: Measure static yield and ultimate strengths, yield stiffness, and fatigue resistance according to an established model. Compare these measured properties with expected loads in vivo. SUMMARY OF BACKGROUND DATA: Multiaxial pedicle screws provide surgical versatility, but the complexity of their design may reduce their strength and fatigue resistance. There is no published data on the mechanical properties of such screws. MATERIALS AND METHOD: Screws were assembled according to a vertebrectomy model for destructive mechanical testing. Groups of five assemblies were tested in static tension and compression and subject to three cyclical loads. Modes of failure, yield, and ultimate strength, yield stiffness, and cycles to failure were determined for six designs of screw. RESULTS: Static compression yield loads ranged from 217.1 to 388.0 N and yield stiffness from 23.7 to 38.0 N/mm. Cycles to failure ranged from 42 x 10(3) to 4,719 x 10(3) at 75% of static ultimate load. There were significant differences between designs in all modes of testing. Failure occurred at the multiaxial link in static and cyclical compression. CONCLUSIONS: Bending yield strengths just exceeded loads expected in vivo. Multiaxial designs had lower static bending yield strength than fixed screw designs. Five out of six multiaxial screw designs achieved one million cycles at 200 N in compression bending. "Ball-in-cup" multiaxial locking mechanisms were vulnerable to fatigue failure. Smooth surfaces and thicker material appeared to be protective against fatigue failure.

Spinal fusion using an autologous growth factor gel and a porous resorbable ceramic.

Augmenting healing through a single application of an exogenous growth factor or bone morphogenetic protein is not a new concept. The use of autologous growth factors through platelet isolation and concentration provides multiple endogenous growth factors to the healing site. A posterolateral fusion model in aged sheep (5- to 6-year-old ewes) was used to examine the effects of the addition of growth factors through autologous platelet isolation on the biomechanic and histologic properties of the fusion using a resorbable coral bone graft substitute. At 6 months the combination of autologous growth factors to the Pro Osteon 500R plus aspirated bone marrow resulted in the greatest bending stiffness but not ultimate load. Autologous growth factors can be isolated from platelets and concentrated to provide multiple growth factors to the fusion site to aid in spinal fusion.