Surgery versus conservative management of stable thoracolumbar fracture: the PRESTO feasibility RCT.

BACKGROUND: There is informal consensus that simple compression fractures of the body of the thoracolumbar vertebrae between the 10th thoracic vertebra and the second lumbar vertebra without neurological complications can be managed conservatively and that obvious unstable fractures require surgical fixation. However, there is a zone of uncertainty about whether surgical or conservative management is best for stable fractures. OBJECTIVES: To assess the feasibility of a definitive randomised controlled trial comparing surgical fixation with initial conservative management of stable thoracolumbar fractures without spinal cord injury. DESIGN: External randomised feasibility study, qualitative study and national survey. SETTING: Three NHS hospitals. METHODS: A feasibility randomised controlled trial using block randomisation, stratified by centre and type of injury (high- or low-energy trauma) to allocate participants 1 : 1 to surgery or conservative treatment; a costing analysis; a national survey of spine surgeons; and a qualitative study with clinicians, recruiting staff and patients. PARTICIPANTS: Adults aged ≥ 16 years with a high- or low-energy fracture of the body of a thoracolumbar vertebra between the 10th thoracic vertebra and the second lumbar vertebra, confirmed by radiography, computerised tomography or magnetic resonance imaging, with at least one of the following: kyphotic angle > 20° on weight-bearing radiographs or > 15° on a supine radiograph or on computerised tomography; reduction in vertebral body height of 25%; a fracture line propagating through the posterior wall of the vertebra; involvement of two contiguous vertebrae; or injury to the posterior longitudinal ligament or annulus in addition to the body fracture. INTERVENTIONS: Surgical fixation: open spinal surgery (with or without spinal fusion) or minimally invasive stabilisation surgery. Conservative management: mobilisation with or without a brace. MAIN OUTCOME MEASURE: Recruitment rate (proportion of eligible participants randomised). RESULTS: Twelve patients were randomised (surgery, n = 8; conservative, n = 4). The proportion of eligible patients recruited was 0.43 (95% confidence interval 0.24 to 0.63) over a combined total of 30.7 recruitment months. Of 211 patients screened, 28 (13.3%) fulfilled the eligibility criteria. Patients in the qualitative study (n = 5) expressed strong preferences for surgical treatment, and identified provision of information about treatment and recovery and when and how they are approached for consent as important. Nineteen surgeons and site staff participated in the qualitative study. Key themes were the lack of clinical consensus regarding the implementation of the eligibility criteria in practice and what constitutes a stable fracture, alongside lack of equipoise regarding treatment. Based on the feasibility study eligibility criteria, 77% (50/65) and 70% (46/66) of surgeons participating in the survey were willing to randomise for high- and low-energy fractures, respectively. LIMITATIONS: Owing to the small number of participants, there is substantial uncertainty around the recruitment rate. CONCLUSIONS: A definitive trial is unlikely to be feasible currently, mainly because of the small number of patients meeting the eligibility criteria. The recruitment and follow-up rates were slightly lower than anticipated; however, there is room to increase these based on information gathered and the support within the surgical community for a future trial. FUTURE WORK: Development of consensus regarding the population of interest for a trial. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12094890. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 62. See the NIHR Journals Library website for further project information.

Fractures occurring in the mid- to low back region (or thoracolumbar fractures) are the most common back fractures. When the fracture is stable with no spinal nerve injury, there is uncertainty whether treatment with surgery or non-surgical treatment (e.g. stabilising the spine with a brace) results in the best outcome for patients. The Pragmatic Randomised Evaluation of Stable Thoracolumbar fracture treatment Outcomes (PRESTO) study aimed to explore whether or not it would be feasible to carry out a full-scale study to find out which of these two treatments works best. Adults aged ≥ 16 years being treated for these fractures in three hospitals were invited to take part in the study. Over the course of 1 year, we assessed how many patients were treated, the number who met the study entry criteria and the proportion of eligible patients who agreed to take part. Staff and patients were interviewed about the study processes and their experiences of taking part. Spine surgeons from around the UK were also asked to complete an online survey, which asked questions about the treatment of patients with this fracture. There were fewer patients than expected who met the study entry criteria and, of these, fewer patients who agreed to take part. There were differences among surgeons about the definition of a stable fracture, and we found that surgeons have strong views about whether or not surgery is appropriate when fractures are stable. We also found that more support would be required for the staff involved in inviting patients to take part in a bigger study, and that the format and content of information provided to patients needs to be improved. The findings of the PRESTO study showed that a large trial is unlikely to be successful at this time; however, we have provided important information for future research into the treatment of these fractures.

Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials.

BACKGROUND: Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research. DESIGN: Two qualitative process evaluations of a UK-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically. SETTING: NHS secondary care organisations throughout the UK. Interviews were undertaken via telephone. PARTICIPANTS: Thirty-seven health professionals including UK-based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). Twenty-two patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed. RESULTS: We used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient's circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients' treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated. CONCLUSIONS: A wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials. TRIAL REGISTRATION: ACTIVE: ( ISRCTN98152560 ). Registered on 06/03/2018. PRESTO: ( ISRCTN12094890 ). Registered on 22/02/2018.

Does Coronavirus Disease 2019 (COVID-19) Affect Perioperative Morbidity and Mortality for Patients Requiring Emergency Instrumented Spinal Surgery? A Single-Center Cohort Study.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic sent shockwaves through health services worldwide. Resources were reallocated. Patients with COVID-19 still required instrumented spinal surgery for emergencies. Clinical outcomes for these patients are not known. The objective of this study was to evaluate the effects of COVID-19 on perioperative morbidity and mortality for patients undergoing emergency instrumented spinal surgery and to determine risk factors for increased morbidity/mortality. METHODS: This retrospective cohort study included 11 patients who were negative for COVID-19 and 8 patients who were positive for COVID-19 who underwent emergency instrumented spinal surgery in 1 hospital in the United Kingdom during the pandemic peak. Data collection was performed through case note review. Patients in both treatment groups were comparable for age, sex, body mass index (BMI), comorbidities, surgical indication, and preoperative neurologic status. Predefined perioperative outcomes were recorded within a 30-day postoperative period. Univariable analysis was used to identify risk factors for increased morbidity. RESULTS: There were no mortalities in either treatment group. Four patients positive for COVID-19 (50%) developed a complication compared with 6 (55%) in the COVID-19-negative group (P > 0.05). The commonest complication in both groups was respiratory infection. Three patients positive for COVID-19 (37.5%) required intensive care unit admission, compared with 4 (36%) in the COVID-19-negative group (P > 0.05). The average time between surgery and discharge was 19 and 10 days in COVID-19-positive and -negative groups, respectively (P = 0.02). In the COVID-19 positive group, smoking, abnormal BMI, preoperative oxygen requirement, presence of fever, and oxygen saturations <95% correlated with increased risk of complications. CONCLUSIONS: Emergency instrumented spinal surgery in patients positive for COVID-19 was associated with increased length of hospital stay. There was no difference in occurrence of complications or intensive care unit admission. Risk factors for increased morbidity in patients with COVID-19 included smoking, abnormal BMI, preoperative oxygen requirement, fever and saturations <95%.

Pragmatic randomised evaluation of stable thoracolumbar fracture treatment outcomes (PRESTO): study protocol for a randomised controlled feasibility trial combined with a qualitative study and survey.

BACKGROUND: A thoracolumbar fracture is the most common fracture of the spinal column. Where the fracture is not obviously stable or unstable, the optimal management is uncertain. There are variations between surgeons, treating centres and within the evidence base as to whether surgical or non-surgical approaches should be used. In addition, the boundaries of this zone of uncertainty for stability are unclear.This study has been designed in response to an NIHR HTA commissioning brief to assess the feasibility of undertaking a large-scale trial to evaluate the effectiveness of surgical and non-surgical treatments for thoracolumbar fractures without neurological deficit. METHODS: Assessment of feasibility will be addressed through three elements: a randomised external feasibility study, a national survey of surgeons and a qualitative study.The external feasibility study is a pragmatic, parallel-group, randomised controlled trial comparing surgical fixation (intervention) versus non-surgical management (control). Recruitment will take place in three secondary care centres in the UK.The primary outcome is recruitment rate, defined as the proportion of eligible participants who are randomised. Further outcomes related to recruitment, randomisation, drop-out, cross-over, loss to follow-up, completeness of outcome data, study processes and details of the interventions delivered will be collected.The survey of surgeons and qualitative study of clinicians, recruiting staff and patients will enhance the feasibility study, enabling a broad overview of current practice in the field in addition to perceived facilitators and barriers to running a full-scale trial. DISCUSSION: PRESTO is a feasibility study which aims to inform methodology for a definitive trial comparing surgical fixation with non-surgical management for patients with stable thoracolumbar fractures. TRIAL REGISTRATION: The trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN12094890). Date of registration was 22/02/2018 (http://www.isrctn.com/ISRCTN12094890).

A Comparison of Three Different Methods of Fixation in the Management of Thoracolumbar Fractures.

BACKGROUND: Management of thoracolumbar fractures remains controversial in the literature. The primary aims of this study were to assess different levels of fixation with respect to radiological outcomes in terms of fracture reduction and future loss of correction. METHODS: This is a single center, retrospective study. Fifty-five patients presenting with thoracolumbar fractures between January 2012 and December 2015 were analyzed in the study. The levels of fixation were divided in 3 groups: 1 vertebra above and 1 below the fracture (1/1), 2 above and 2 below (2/2), and 2 above and 1 below (2/1). RESULTS: The most common mechanism was high fall injury, and the most common vertebra L1. Burst fractures were the ones with the highest incidence. The 2/2 fixation achieved the best reduction of the fracture, but with no statistical significance. The correction is maintained better by the 2/2 fixation, but there is no statistical difference compared to the other fixations. Insertion of screws at the fracture level did not improve outcomes. CONCLUSION: The data of this study identified a trend toward better radiological outcomes for fracture reduction and maintenance of the correction in the 2/2 fixations. However, these results are not statistically significant. Future multicenter prospective clinical trials are needed in order to agree on the ideal management and method of fixation for thoracolumbar fractures.

Spinopelvic Dissociation: A Retrospective Case Study and Review of Treatment Controversies.

INTRODUCTION: Spinopelvic dissociation is a rare injury resulting in discontinuity between the spine and pelvis. We review the English- language literature and discuss critical treatment controversies. We present a series of spinopelvic dissociation cases from a level I trauma center. METHODS: In this retrospective review of 18 consecutive cases treated surgically over a period of 4 years, we collected patient, injury, and surgical demographics and clinical and radiographic outcome measures. RESULTS: Twelve patients had associated injuries, five were intubated on arrival, and six had neurologic deficits at presentation. No patient had spinal decompression, and all patients underwent closed reduction and percutaneous fixation. There were no cases of iatrogenic nerve injury, despite the use of partially threaded sacroiliac screws and closed reduction techniques. Five patients showed progressive neurologic improvement postoperatively. After reduction, eight patients (44%) had radiographic loss of the sacrococcygeal angle at the latest follow-up, but correction of fracture translation was preserved in all. DISCUSSION: Spinopelvic dissociation represents a heterogeneous group of injuries often in the context of polytraumatized patients with other injuries. Our closed reduction and fixation technique resulted in satisfactory outcomes. We present a treatment algorithm for these rare injuries.

Teriparatide and vertebral fracture healing in Ankylosing Spondylitis.

Patients with Ankylosing Spondylitis (AS) are four times more likely to sustain spinal fractures. Due to the associated risk of neurological complications treatment is complex. We present the case of a 56-year-old Caucasian gentleman with AS who sustained a fracture of T2 vertebra following a traumatic hyperextension injury. He declined surgery in fear of complications and started treatment with subcutaneous Teriparatide at a dose of 20 mg daily for six months. There was complete healing of the vertebral fracture at 6 months without any complications. This case is unique as complete healing was achieved without preceding surgical intervention. Further exploration of the use of Teriparatide in spinal fractures in patients with AS is recommended to support the theories generated by this and other existing cases in the literature.

A Comparison of Three Different Methods of Fixation in the Management of Thoracolumbar Fractures.

INTRODUCTION: Management of thoracolumbar fractures remains controversial in the literature. The primary aims of this study were to assess different levels of fixation with respect to radiological outcomes in terms of fracture reduction and future loss of correction. METHODS: This is a single center, retrospective study. Fifty-five patients presenting with thoracolumbar fractures between January 2012 and December 2015 were analyzed in the study. The levels of fixation were divided in 3 groups, 1 vertebra above and 1 below the fracture (1/1), 2 above and 2 below (2/2), and 2 above and 1 below (2/1). RESULTS: The most common mechanism was high fall injury and the most common vertebra L1. Burst fractures were the ones with the highest incidence. The 2/2 fixation achieved the best reduction of the fracture but with no statistical significance. The correction is maintained better by the 2/2 fixation but there is no statistical difference compared to the other fixations. Insertion of screws at the fracture level did not improve outcomes. CONCLUSION: The data of this study identified a trend towards better radiological outcomes for fracture reduction and maintenance of the correction in the 2/2 fixations. However these results are not statistically significant. Future multicenter prospective clinical trials are needed in order to agree on the ideal management and method of fixation for thoracolumbar fractures.

New treatments and imaging strategies in degenerative disease of the intervertebral disks.

Magnetic resonance (MR) imaging in patients with persistent low back pain and sciatica effectively demonstrates spine anatomy and the relationship of nerve roots and intervertebral disks. Except in cases with nerve root compression, disk extrusion, or central stenosis, conventional anatomic MR images do not help distinguish effectively between painful and nonpainful degenerating disks. Hypoxia, inflammation, innervation, accelerated catabolism, and reduced water and glycosaminoglycan content characterize degenerated disks, the extent of which may distinguish nonpainful from painful ones. Applied to the spine, "functional" imaging techniques such as MR spectroscopy, T1ρ calculation, T2 relaxation time measurement, diffusion quantitative imaging, and radio nucleotide imaging provide measurements of some of these degenerative features. Novel minimally invasive therapies, with injected growth factors or genetic materials, target these processes in the disk and effectively reverse degeneration in controlled laboratory conditions. Functional imaging has applications in clinical trials to evaluate the efficacy of these therapies and eventually to select patients for treatment. This report summarizes the biochemical processes in disk degeneration, the application of advanced disk imaging techniques, and the novel biologic therapies that presently have the most clinical promise.

Isolated noncompaction of right ventricle--a case report.

Isolated noncompaction of ventricular myocardium (INVM) is a genetic cardiomyopathy due to abnormal arrest in endomyocardial embryogenesis between fetal 5th and 8th week. Noncompaction of right ventricle alone is rare. Here we present one such case where a young man presented with progressive right heart failure and atrial fibrillation. Subsequent evaluation by echo and cardiac magnetic resonance imaging confirmed our diagnosis. The cardinal manifestations of INVM are heart failure, arrhythmia, and embolic events and our case presented with former two manifestations. Echocardiographic criteria for diagnosing INVM are discussed.