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.

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.

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.

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.

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.