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.

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.

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.

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.

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.

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.