Duroplasty for injured cervical spinal cord with uncontrolled swelling: protocol of the DISCUS randomized controlled trial.

BACKGROUND: Cervical traumatic spinal cord injury is a devastating condition. Current management (bony decompression) may be inadequate as after acute severe TSCI, the swollen spinal cord may become compressed against the surrounding tough membrane, the dura. DISCUS will test the hypothesis that, after acute, severe traumatic cervical spinal cord injury, the addition of dural decompression to bony decompression improves muscle strength in the limbs at 6 months, compared with bony decompression alone. METHODS: This is a prospective, phase III, multicenter, randomized controlled superiority trial. We aim to recruit 222 adults with acute, severe, traumatic cervical spinal cord injury with an American Spinal Injury Association Impairment Scale grade A, B, or C who will be randomized 1:1 to undergo bony decompression alone or bony decompression with duroplasty. Patients and outcome assessors are blinded to study arm. The primary outcome is change in the motor score at 6 months vs. admission; secondary outcomes assess function (grasp, walking, urinary + anal sphincters), quality of life, complications, need for further surgery, and mortality, at 6 months and 12 months from randomization. A subgroup of at least 50 patients (25/arm) also has observational monitoring from the injury site using a pressure probe (intraspinal pressure, spinal cord perfusion pressure) and/or microdialysis catheter (cord metabolism: tissue glucose, lactate, pyruvate, lactate to pyruvate ratio, glutamate, glycerol; cord inflammation: tissue chemokines/cytokines). Patients are recruited from the UK and internationally, with UK recruitment supported by an integrated QuinteT recruitment intervention to optimize recruitment and informed consent processes. Estimated study duration is 72 months (6 months set-up, 48 months recruitment, 12 months to complete follow-up, 6 months data analysis and reporting results). DISCUSSION: We anticipate that the addition of duroplasty to standard of care will improve muscle strength; this has benefits for patients and carers, as well as substantial gains for health services and society including economic implications. If the addition of duroplasty to standard treatment is beneficial, it is anticipated that duroplasty will become standard of care. TRIAL REGISTRATION: IRAS: 292031 (England, Wales, Northern Ireland) - Registration date: 24 May 2021, 296518 (Scotland), ISRCTN: 25573423 (Registration date: 2 June 2021); ClinicalTrials.gov number : NCT04936620 (Registration date: 21 June 2021); NIHR CRN 48627 (Registration date: 24 May 2021).

Neurological recovery after early versus delayed surgical decompression for acute traumatic spinal cord injury.

The aim of this study was to determine whether early surgical treatment results in better neurological recovery 12 months after injury than late surgical treatment in patients with acute traumatic spinal cord injury (tSCI). Patients with tSCI requiring surgical spinal decompression presenting to 17 centres in Europe were recruited. Depending on the timing of decompression, patients were divided into early (≤ 12 hours after injury) and late (> 12 hours and < 14 days after injury) groups. The American Spinal Injury Association neurological (ASIA) examination was performed at baseline (after injury but before decompression) and at 12 months. The primary endpoint was the change in Lower Extremity Motor Score (LEMS) from baseline to 12 months. The final analyses comprised 159 patients in the early and 135 in the late group. Patients in the early group had significantly more severe neurological impairment before surgical treatment. For unadjusted complete-case analysis, mean change in LEMS was 15.6 (95% confidence interval (CI) 12.1 to 19.0) in the early and 11.3 (95% CI 8.3 to 14.3) in the late group, with a mean between-group difference of 4.3 (95% CI -0.3 to 8.8). Using multiply imputed data adjusting for baseline LEMS, baseline ASIA Impairment Scale (AIS), and propensity score, the mean between-group difference in the change in LEMS decreased to 2.2 (95% CI -1.5 to 5.9). Compared to late surgical decompression, early surgical decompression following acute tSCI did not result in statistically significant or clinically meaningful neurological improvements 12 months after injury. These results, however, do not impact the well-established need for acute, non-surgical tSCI management. This is the first study to highlight that a combination of baseline imbalances, ceiling effects, and loss to follow-up rates may yield an overestimate of the effect of early surgical decompression in unadjusted analyses, which underpins the importance of adjusted statistical analyses in acute tSCI research.

Stable closure of acute and chronic wounds and pressure ulcers and control of draining fistulas from osteomyelitis in persons with spinal cord injuries: non-interventional study of MPPT passive immunotherapy delivered via telemedicine in community care.

Background: Micropore particle technology (MPPT) is a topical wound treatment. It is a passive immunotherapy, acting via the skin and wound microbiome without the use of antimicrobial action. In a general patient population, it removed wound infections 60% and initiated tissue regeneration 50% quicker than antibiotics and antiseptics. As MPPT supports the immune system, the aim was to confirm that MPPT is also effective in immunocompromised individuals. People with spinal cord injury (SCI) are immunodeficient due to their injury and not an underlying disease and recruit 50% fewer immune cells to an injury. The study, therefore, determined the efficacy, safety, health economics, and sustainability of MPPT in acute and chronic wounds and pressure ulcers in this patient population. Methods: Pressure ulcers in SCI persons are an orphan indication, patient variability is high, and ICH E10 excludes comparators due to ethical concerns. The study design was, therefore, a single-arm, non-interventional, observational, post-market surveillance study of MPPT for treating wounds and pressure ulcers and removing soft tissue infection in connection with draining fistulas in SCI persons. The study was based on telemedicine in community care. Results: The study included 44 wounds. All acute and chronic grade 1-4 wounds and pressure ulcers reached stable closure. In wounds acting as fistulas draining from an underlying, primary focus of infection, e.g., osteomyelitis, MPPT removed the soft tissue infection in approx. 2.5 months and supported regeneration, considerably reducing fistula sizes. Compared to standard care, per-wound cost savings were 51 to 94% depending on wound grade and age, and substantial nursing resources were freed up. The telemedicine approach was well received by participants and supported independence and self-care. The use of antimicrobials, plastics, and synthetic polymers was essentially eliminated. MPPT did not require bed rest. Conclusion: The study confirmed that MPPT is safe and effective in treating acute and chronic wounds in immunocompetent and immunocompromised individuals, including wounds with antimicrobial-resistant infections. MPPT also removes soft tissue infections caused by an underlying primary focus of infection, such as osteomyelitis. Non-healing wounds currently represent an unmet clinical need. The findings suggest that a therapy acting via the microbiome without antimicrobial actions is effective.

Iatrogenic post-surgical tension pneumosyrinx-a first reported case.

We describe the first ever-reported occurrence of a post-operative tension pneumosyrinx occurring after a resection of an intradural intramedullary spinal tumour in a 40-year-old patient. Post-operatively, he developed sudden onset paraplegia and imaging revealed a tension pneumosyrinx which was subsequently surgically decompressed. He made a gradual neurological recovery. This is an extremely rare complication with potentially long-lasting deleterious effects on patients' neurological status if not recognized. We aim to bring this pathology to the attention of our neurosurgical colleagues and share our surgical approach and management to assist those who may encounter this pathology in the future.

Predictive equations over estimating resting metabolic rate in individual with spinal cord injury requiring mechanical ventilation support - A case series.

Context: The impact of mechanical ventilation on energy expenditure after spinal cord injury (SCI) is sparse. The objective of this case-series is to measure 15-minutes resting metabolic rate (RMR) to determine 24-hours measured-RMR (m-RMR) using QUARK indirect calorimeter (IC) and; compare the m-RMR with estimated RMR (e-RMR) using four commonly used predictive equations (Harris-Benedict, Mifflin St-Jeor, Henry and Schofield).Findings: We measured the RMR of four patients with SCI (one male and three female; mean age: 58.3 years) all with complete tetraplegia (ISNCSCI A) twice in a one-week interval using an IC with two sampling flow settings during a six month period. The median (IQ) of all m-RMRs was 1094 (340.2) kcal/day. The median m-RMR was 40.1% lower than the median calculated with four different e-RMRs using predictive equations. All four predictive equations overestimated RMR in SCI patients requiring mechanical ventilation by 4.1-61.1% (Harris-Benedict: 28.8-60.6%; Mifflin St-Jeor: 6.9-61.1%; Henry: 4.1-58.9% and; Schofield: 6-54.6%).Conclusion/clinical relevance: There is a high variability of e-RMR and m-RMR in patients with SCI who are dependent on mechanical ventilation. The use of predictive equations may lead to over-estimation of energy requirements. To avoid overfeeding we recommended measuring RMR using IC wherever possible. A further study with a larger sample size is needed due to the small number of subjects in our case-series. Development of a validated RMR equation in the SCI population is warranted.

Pelvic MRI in spinal cord injury patients: incidence of muscle signal change and early heterotopic ossification.

STUDY DESIGN: Prospective observational study. OBJECTIVE: To evaluate pelvic MRI muscle signal changes and their association with early heterotopic ossification (HO) in patients with spinal cord injuries. SETTING: National Spinal Injuries Unit, Stoke Mandeville, UK. METHODS: Forty patients were imaged with at least two interval magnetic resonance (MR) studies of the pelvis in the first 6 months following a spinal cord injury. Scans were reviewed and scored for heterotopic ossification, muscle signal change and extent of muscle involvement. RESULTS: Muscle signal change was present in 28 (70%) on the initial MRI and 31 (77%) by the second study. Six patients developed MR changes of prodromal or immature heterotopic ossification (15%). No restricted diffusion was demonstrated and no patient developed mature HO. Patients developing MR changes of early HO were more likely to have grade 3 muscle changes. CONCLUSION: Increased T2 muscle signal is common following cord injury, is frequently progressive in the subacute period and is associated with complete injury and early MR signs of heterotopic ossification.

Immunotherapy to reduce frequency of urinary tract infections in people with neurogenic bladder dysfunction; a pilot randomised, placebo-controlled trial.

OBJECTIVE: To establish the feasibility of a randomized, placebo-controlled trial to investigate the effect of a specific immunotherapy bacterial lysate OM-89 (Uro-Vaxom®) in reducing the frequency of urinary tract infections in people with neurogenic bladder dysfunction. DESIGN: A parallel-group, double-blind, randomized, placebo-controlled trial. SETTING: Patients at home, recruited through out-patient contact, social media and patient support groups. SUBJECTS: People with a spinal cord injury, multiple sclerosis, transverse myelitis or cauda equina syndrome who had suffered three or more clinically diagnosed urinary tract infections treated with antibiotics over the preceding 12 months. INTERVENTIONS: All participants took one capsule of oral OM-89 immunotherapy (6 mg) or matching Placebo (randomisation ratio 1:1), once daily in the morning for 3 months. MAIN MEASURES: The primary outcome was occurrence of a symptomatic urinary tract infection treated with an antibiotic, assessed at 3 and 6 months. Feasibility measures included recruitment, retention and practical difficulties. RESULTS: Of 115 patients screened, 49 were recruited, one withdrew before randomization, and 23 were allocated to the control group receiving matching placebo. Six participants, all in the control group, discontinued the intervention; all participants provided full data at both follow-up times. Over 6 months, 18/25 active group patients had 55 infections, and 18/23 control group patients had 47 infections. Most research and clinical procedures were practical, and acceptable to participants. CONCLUSION: It is feasible to undertake a larger trial. We recommend broader inclusion criteria to increase eligibility and generalizability.

Rapid incremental closed traction reduction of cervical facet fracture dislocation: the Stoke Mandeville experience.

STUDY DESIGN: Retrospective case series study. OBJECTIVE: To determine the success rate and neurological outcomes of rapid incremental closed traction reduction (RICTR) of cervical dislocations with spinal cord compression in the National Spinal Injuries Centre (NSIC), between June 2006 and December 2011. SETTING: Tertiary spinal injuries centre, Stoke Mandeville Hospital, UK. METHODS: A list of cervical trauma patients who were admitted to NSIC between January 2006 and December 2011 was retrieved from the hospital's electronic records, consultant and admission logbooks. Patients, admitted within 7 days of cervical facet dislocation and spinal cord injury (SCI), were included. Retrospective data collection and analysis was done using a data collection form and an Excel spreadsheet. RESULTS: Seventeen patients have met the eligibility criteria of the study. One patient was excluded because he only had nerve root symptoms. The procedure was successful in 44% of the cases. Eighty-six percent of patients in the successful RICTR group improved in their discharge motor index score (MIS), whereas 43% improved in their post-reduction MIS. Overall, 81% of the cohort had improvements in their discharge MIS. CONCLUSION: Our RICTR success rate was low compared to the reported average success rate in the literature, likely due to delays in admission. Neurological outcomes were favourable in the majority of patients at discharge. In our opinion, early admission and RICTR attempts could have improved the results and therefore we would recommend that RICTR procedures are done for suitable patients in the Emergency Departments of Major Trauma Centres (MTC).

Cervicothoracic arachnoiditis-a rare complication of aneurysmal intracranial subarachnoid haemorrhage.

INTRODUCTION: Subarachnoid haemorrhage is a catastrophic condition which has significant morbidity and mortality, with mortality rate ranging between 8-67% and is associated with significant morbidity among the survivors. Arachnoiditis of the spinal cord is a very rare complication which can occur months to years after the subarachnoid haemorrhage. CASE PRESENTATION: We report a case of cervicothoracic arachnoiditis following the subarachnoid haemorrhage secondary to posterior inferior cerebellar artery (PICA) aneurysm with posterior fossa AVM (arterio-venous malformation) causing dense paraplegia. DISCUSSION: The haemorrhage that occurs into the fourth ventricle passes to the subarachnoid space via foramen of Magendie and Luschka. This subsequently induces inflammatory changes of the meninges predisposing to arachnoiditis. Early recognition and intervention may prevent this devastating complication or at least reduce the morbidity.

Thromboembolism in the Sub-Acute Phase of Spinal Cord Injury: A Systematic Review of the Literature.

To review the evidence of thromboembolism incidence and prophylaxis in the sub-acute phase of spinal cord injury (SCI) 3-6 months post injury. All observational and experimental studies with any length of follow-up and no limitations on language or publication status published up to March 2015 were included. Two review authors independently selected trials for inclusion and extracted data. Outcomes studied were incidence of pulmonary embolism (PE) and deep vein thrombosis (DVT) in the sub-acute phase of SCI. The secondary outcome was type of thromboprophylaxis. Our search identified 4305 references and seven articles that met the inclusion criteria. Five papers reported PE events and three papers reported DVT events in the sub-acute phase of SCI. Studies were heterogeneous in populations, design and outcome reporting, therefore a meta-analysis was not performed. The included studies report a PE incidence of 0.5%-6.0% and DVT incidence of 2.0%-8.0% in the sub-acute phase of SCI. Thromboprophylaxis was poorly reported. Spinal patients continue to have a significant risk of PE and DVT after the acute period of their injury. Clinicians are advised to have a low threshold for suspecting venous thromboembolism in the sub-acute phase of SCI and to continue prophylactic anticoagulation therapy for a longer period of time.

Review: indications for interventional radiology in the management of patients with spinal cord injuries.

OBJECTIVES: To outline a range of minimally invasive image-guided procedures that benefit spinal cord-injured patients and may expedite clinical care. STUDY DESIGN: Pictorial review. RESULTS/CONCLUSIONS: Image-guided procedures have made a significant impact in medical management in many specialties. These techniques continue to evolve rapidly and afford opportunities to reduce patient morbidity and in-patient length of stay.