Investigating the Effect of Axial Compression and Distraction on Cervical Facet Mechanics During Supraphysiologic Anterior Shear.

Bilateral cervical facet dislocation (BFD) with facet fracture (Fx) often causes tetraplegia but is rarely recreated experimentally, possibly due to a lack of muscle replication. Intervertebral axial compression (due to muscle activation) or distraction (due to inertial loading), when combined with excessive anterior translation, may influence interfacet contact or separation and the subsequent production of BFD with or without Fx. This paper presents a methodology to produce C6/C7 BFD+Fx using anterior shear motion superimposed with 300 N compression or 2.5 mm distraction. The effect of these superimposed axial conditions on six-axis loads, and C6 inferior facet deflections and surface strains, was assessed. Twelve motion segments (70 ± 13 yr) achieved 2.19 mm of supraphysiologic anterior shear without embedding failure (supraphysiologic shear analysis point; SSP), and BFD+Fx was produced in all five specimens that reached 20 mm of shear. Linear mixed-effects models (α = 0.05) assessed the effect of axial condition. At the SSP, the compressed specimens experienced higher axial forces, facet shear strains, and sagittal facet deflections, compared to the distracted group. Facet fractures had similar radiographic appearance to those that are observed clinically, suggesting that intervertebral anterior shear motion contributes to BFD+Fx.

Lumbar spine loads are reduced for activities of daily living when using a braced arm-to-thigh technique.

PURPOSE: To evaluate the effect of the braced arm-to-thigh technique (BATT) (versus self-selected techniques) on three-dimensional trunk kinematics and spinal loads for three common activities of daily living (ADLs) simulated in the laboratory: weeding (gardening), reaching for an object in a low cupboard, and car egress using the two-legs out technique. METHODS: Ten young healthy males performed each task using a self-selected technique, and then using the BATT. The pulling action of weeding was simulated using a magnet placed on a steel plate. Cupboard and car egress tasks were simulated using custom apparatus representing the dimensions of a kitchen cabinet and a medium-sized Australian car, respectively. Three-dimensional trunk kinematics and L4/L5 spinal loads were estimated using the Lifting Full-Body OpenSim model and compared between techniques. Paired t-tests were used to compare peak values between methods (self-selected vs BATT). RESULTS: The BATT significantly reduced peak extension moments (13-51%), and both compression (27-45%) and shear forces (31-62%) at L4/L5, compared to self-selected techniques for all three tasks (p < 0.05). Lateral bending angles increased with the BATT for weeding and cupboard tasks, but these changes were expected as the BATT inherently introduces asymmetric trunk motion. CONCLUSION: The BATT substantially reduced L4/L5 extension moments, and L4/L5 compression and shear forces, compared to self-selected methods, for three ADLs, in a small cohort of ten young healthy males without prior history of back pain. These study findings can be used to inform safe procedures for these three ADLs, as the results are considered representative of a mature population.

Local Bone Grafting Is Sufficient for Instrumented Adolescent Idiopathic Scoliosis Surgery: A Preliminary Study.

BACKGROUND: Several options for grafting exist; iliac crest bone grafting, allografts, and bone substitutes. Local bone graft (LBG) offers high-quality bone graft and no commercial cost. The aim of this study was to assess the clinical and radiologic results of adolescent idiopathic scoliosis (AIS) surgery with posterior instrumentation and fusion (PIF) in patients using only LBG and to measure the quantities harvested. METHODS: A total of 218 AIS patients who underwent pedicle screw PIF surgery using only LBG with a minimum 1-year follow-up were reviewed. Bone was harvested during surgery from the excised facet joints, spinous processes (not from the end instrumented vertebrae) and decortication of laminae and transverse processes in the operative field. The harvested bone graft weight of 127 patients was recorded prospectively and then computed to graft weight per kilogram body weight (GWPK) and graft weight per motion segment (GWPMS). RESULTS: The median follow-up time was 24.7 months (12.1 to 133 mo) with 128 of the 218 patients having over 2 years follow-up. A total of 280 curves were fused. One hundred fifty-six of the patients had single curve instrumentation and 62 had double curve surgery. The median preoperative primary Cobb angle was 57.0 (31 to 100) degrees and postoperatively was 20.0 (0 to 66) degrees, indicating a median correction of 65.3% (17.5% to 100%). The median graft weight was 30 g (14 to 62 g), GWPK was 0.54 g/kg (0.24 to 1.29 g/kg) and GWPMS was 3.3 g/motion segments (2.3 to 10.0 g/kg). Twelve of 218 patients (5.5%) required subsequent surgery. Only 2 patients developed pseudarthrosis (0.91%), noting that modern segmental instrumentation warrants longer follow-up for increased confidence of complete fusion. CONCLUSIONS: LBG achieved successful fusion in over 99% of patients undergoing PIF for AIS. The described terms GWPK and GWPMS can be insightful for future studies. LBG offers a safe and low-cost solution for bone grafting in AIS surgery. LEVEL OF EVIDENCE: Level IV.

Is the duration of pre-operative conservative treatment associated with the clinical outcome following surgical decompression for lumbar spinal stenosis? A study based on the Spine Tango Registry.

BACKGROUND: The incidence of lumbar spinal stenosis (LSS) continues to rise, with both conservative and surgical management representing options for its treatment. The timing of surgery for LSS varies from shortly after the onset of symptoms to several months or years after conservative treatment. The aim of this study was to investigate the association between the duration of pre-operative conservative treatment and the ultimate outcome following surgical interventions for LSS. METHODS: The study was based on prospective multicentre registry data (Spine Tango). Cases of LSS with a documented duration of conservative treatment, undergoing spinal decompression with at least one post-operative patient assessment between 3 and 30 months, were included in the study. Cases of LSS with spondylolisthesis, additional spinal pathology or previous spinal surgery were excluded. Interrogation of the Spine Tango Registry listed 3478 patients meeting the prescribed inclusion criteria. This cohort was stratified into four groups: (1) no previous treatment (n = 497; 14.3%), (2) conservative treatment <6 months (n = 965; 27.8%), (3) conservative treatment between 6 and 12 months (n = 758; 21.8%), and (4) conservative treatment >12 months (n = 1258; 36.1%). Group 4 reference group in regression analysis. The inverse probability of treatment weighting (IPTW) was applied using the propensity score to balance the groups for their characteristics. Outcome measures included achievement of the minimum clinically important change (MCIC) score of 2 points for (a) back pain, (b) leg pain and (c) Core Outcome Measures Index (COMI), and (d) surgical complications, (e) general complications and (f) operation time >2 h. RESULTS: Patient group ("duration of conservative therapy") was not associated with achievement of the MCIC for post-operative relief of leg pain (p = 0.22), achievement of MCIC for the COMI score (p = 0.054), surgical complications (p = 0.11) or general complications (p = 0.14). Only MCIC for post-operative relief of back pain (p = 0.021) and operation time were significantly associated with patient group (p = 0.038). However, compared with the reference group of >12 months of conservative treatment there was no significant difference in the likelihood of achieving the MCIC for those with none, <6 or 6-12 months of conservative treatment. CONCLUSIONS: The duration of pre-operative conservative treatment was not associated with the ultimate outcome of decompression surgery. Further research is required to investigate optimal thresholds/indications for surgery and its appropriate timing in individual patients.

Serum titanium, niobium and aluminium levels two years following instrumented spinal fusion in children: does implant surface area predict serum metal ion levels?

PURPOSE: Measurement of serum metal ion levels is used to determine systemic exposure to implant-derived metal debris that may be generated by processes of wear and corrosion. The aim of this study is to investigate predictors of serum metal ion levels in children undergoing instrumented spinal arthrodesis using a titanium alloy, focusing on implant characteristics and instrumentation construct design variables. METHODS: This prospective longitudinal cohort study involved 33 children. Serum samples were obtained preoperatively:and at five defined interval periods over the first:two post-operative years. Samples were analysed using high resolution:inductively coupled plasma mass spectrometry to measure titanium, niobium and aluminium concentrations. Instrumentation characteristics were catalogued and construct surface area (SA) measurements calculated using an implant-specific software algorithm tool. RESULTS: Significantly elevated levels of serum titanium and niobium were observed (p< 0.0001), with >95 % of post-operative levels abnormally elevated. Significant predictors of serum titanium and niobium levels included time since surgery, surgical procedure (posterior or anterior fusion), number of levels fused, number of pedicle screws inserted, total rod length, total metal SA, total exposed metal SA and total metal-on-metal SA. All significant instrumentation variables were highly correlated. CONCLUSIONS: There is a strong relationship between implant SA and both serum titanium and niobium levels. The direct clinical implications of these findings for patients are uncertain, but remain of concern. Surgeons should be aware of the strong correlation between implant surface area of the chosen construct and the subsequent serum metal ion levels.

Prehospital Cardiovascular Autoregulatory Disturbances Correlate With the Functional Neuroanatomy of Acute Spinal Cord Injury.

STUDY DESIGN: Retrospective study. OBJECTIVE: The importance of attenuating the cardiovascular autoregulatory disturbances accompanying acute spinal cord injury (SCI) has long been recognized. This report assembles SCI emergency service data and correlates cardiovascular parameters to preserved functional neuroanatomy. SUMMARY OF BACKGROUND DATA: The nascent nature of evidence-based reporting of prehospital cardiovascular autoregulatory disturbances in SCI indicates the need to assemble more information. MATERIALS AND METHODS: SCI data for <24 hours were extracted from ambulance and hospital records. The mean arterial pressure (MAP) was calculated. The International Standard for Neurological Classification of SCI (ISNCSCI) evaluates the primary outcome of motor incomplete injury (grades C/D) at acute presentation. Logistic regression was adjusted for multiple confounders that were expected to influence the odds of grade C/D. RESULTS: A cohort of 99 acute SCI cases was retained; mean (SD) age 40.7±20.5 years, 88 male, 84 tetraplegic, 65 grades A/B (motor complete injury), triage time 2±1.6 hours. The lowest recorded prehospital MAP [mean (SD): 77.9±19, range: 45-145 mm Hg] approached the nadir for adequate organ perfusion. Thirty-four (52%) grade A/B and 10 (30%) C/D cases had MAP readings <85 mm Hg. In data adjusted for age, injury level, and triage time a 5 mm Hg increase in the lowest MAP value was associated with a 34% increase in the odds of having motor incomplete injury at acute presentation (adjusted odds ratio=1.34; 95% CI: 1.11-1.61; P =0.002). CONCLUSION: An important observation with implications for timely and selective cardiovascular resuscitation during SCI prehospital care involves significant negative associations between the depth of systemic hypotension and preserved functional neuroanatomy. Regardless of the mechanism, our confounder-adjusted logistic regression model extends in-hospital evidence and provides a conceptual bedside-bench framework for future investigations.

Survival Model of Thoracic Contusion Spinal Cord Injury in the Domestic Pig.

Spinal cord injury (SCI) frequently results in motor, sensory, and autonomic dysfunction for which there is currently no cure. Recent pre-clinical and clinical research has led to promising advances in treatment; however, therapeutics indicating promise in rodents have not translated successfully in human trials, likely due, in part, to gross anatomical and physiological differences between the species. Therefore, large animal models of SCI may facilitate the study of secondary injury processes that are influenced by scale, and may assist the translation of potential therapeutic interventions. The aim of this study was to characterize two severities of thoracic contusion SCI in female domestic pigs, measuring motor function and spinal cord lesion characteristics, over 2 weeks post-SCI. A custom-instrumented weight-drop injury device was used to release a 50 g impactor from 10 cm (n = 3) or 20 cm (n = 7) onto the exposed dura, to induce a contusion at the T10 thoracic spinal level. Hind limb motor function was assessed at 8 and 13 days post-SCI using a 10-point scale. Volume and extent of lesion-associated signal hyperintensity in T2-weighted magnetic resonance (MR) images were assessed at 3, 7, and 14 days post-injury. Animals were transcardially perfused at 14 days post-SCI and spinal cord tissue was harvested for histological analysis. Bowel function was retained in all animals and transient urinary retention occurred in one animal after catheter removal. All animals displayed hind limb motor deficits. Animals in the 10-cm group demonstrated some stepping and weight-bearing and scored a median 2-3 points higher on the 10-point motor function scale at 8 and 13 days post-SCI, than did the 20-cm group. Histological lesion volume was 20% greater, and 30% less white matter was spared, in the 20-cm group than in the 10-cm group. The MR signal hyperintensity in the 20-cm injury group had a median cranial-caudal extent approximately 1.5 times greater than the 10-cm injury group at all three time-points, and median volumes 1.8, 2.5, and 4.5 times greater at day 3, 7, and 14 post-injury, respectively. Regional differences in axonal injury were observed between groups, with amyloid precursor protein immunoreactivity greatest in the 20-cm group in spinal cord sections adjacent to the injury epicenter. This study demonstrated graded injuries in a domestic pig strain, with outcome measures comparable to miniature pig models of contusion SCI. The model provides a vehicle for the study of SCI and potential treatments, particularly where miniature pig strains are not available and/or where small animal models are not appropriate for the research question.

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.

Radiologic assessment of spinal fusion.

Since surgical fusion of the spine was first described in 1911, multiple methods have been used to assess it. Although open surgical exploration remains the standard of care for determination of fusion, it is impractical in most clinical situations. Static radiographs have long been used as a practical method of fusion assessment, but they tend to significantly overestimate the presence of a solid fusion. Dynamic radiographs improve accuracy but limitations include measurement reliability, disagreement on allowable motion, and the two-dimensional nature of radiographs. Ultimately, lack of movement at a fused segment does not confirm fusion. Radiostereometric analysis further improves accuracy; however, methodological demands make it largely impractical for routine use. CT is now widely accepted as the standard for noninvasive assessment of spinal fusion. Fine-cut imaging, multiplanar reconstruction, and metal artifact reduction have increased the ability to assess fusion on CT. However, significant concerns remain regarding the effects of high radiation exposure. Although MRI is appealing, its utility in assessing fusion remains unproven. Understanding the limitations of each technique allows judicious use of radiology in the assessment of spinal fusion.

Persistently Raised Serum Titanium Levels After Spinal Instrumentation in Children.

STUDY DESIGN: Prospective study of patients undergoing elective spinal deformity surgery with repeated testing for circulating metal ions including preoperative levels acting as controls. OBJECTIVE: The aim was to determine if levels of particular circulating metal ions are maintained to two years postsurgery including different implant systems and rods. SUMMARY OF BACKGROUND DATA: Adults having hip replacements, especially metal-on-metal bearings, may develop high metal ion levels. Pediatric spinal implants are known to cause circulating metal ions, notably titanium, chromium, cobalt, and nickel. MATERIALS AND METHODS: Fifty-six children having spinal deformity surgery were studied with repeated testing for circulating metal ions, using high-resolution inductively coupled plasma mass spectrometry. Linear mixed-effects models adjusting for repeated measurements over time were used to analyze levels of titanium, cobalt, chromium, and nickel. RESULTS: Titanium levels showed a rapid increase by seven days and a peak at 30 days that was essentially maintained at the two-year assay. At two years, titanium levels were 5.14 times greater compared with the presurgery control level (P<0.0001). Cobalt levels were shown to gradually rise to a peak at 30 days and then slowly decline but remained 1.74 times above mean baseline level at two years (P=0.0004), with a declining trajectory. Chromium and nickel levels rose immediately postoperatively and then steadily declined to baseline by six months and remained at baseline at two years. The five implant systems tested had generally equivalent results. CONCLUSION: The persistent and rising levels of titanium, in a predominantly female population, is concerning. Titanium is known to cross the placental barrier and enter the circulation of the fetus in rodents and humans, and to accumulate in solid organs especially the liver, spleen, heart, and lymph nodes in humans. This potentially exposes the offspring of mothers with spinal implants to titanium, with potential teratogenic effects.

Mechanisms of Failure Following Simulated Repetitive Lifting: A Clinically Relevant Biomechanical Cadaveric Study.

STUDY DESIGN: A biomechanical analysis correlating internal disc strains and tissue damage during simulated repetitive lifting. OBJECTIVE: To understand the failure modes during simulated safe and unsafe repetitive lifting. SUMMARY OF BACKGROUND DATA: Repetitive lifting has been shown to lead to lumbar disc herniation (LDH). In vitro studies have developed a qualitative understanding of the effect of repetitive loading on LDH. However, no studies have measured internal disc strains and subsequently correlated these with disc damage. METHODS: Thirty human cadaver lumbar functional spinal units were subjected to an equivalent of 1 year of simulated repetitive lifting under safe and unsafe levels of compression, in combination with flexion (13-15°), and right axial rotation (2°) for 20,000 cycles or until failure. Safe or unsafe lifting were applied as a compressive load to mimic holding a 20 kg weight either close to, or at arm's length, from the body, respectively. Maximum shear strains (MSS) were measured, and disc damage scores were determined in nine regions from axial post-test magnetic resonance imaging (MRI) and macroscopic images. RESULTS: Twenty percent of specimens in the safe lifting group failed before 20,000 cycles due to endplate failure, compared with 67% in the unsafe group. Over half of the specimens in the safe lifting group failed via either disc protrusion or LDH, compared with only 20% via protrusion in the unsafe group. Significant positive correlations were found between MRI and macroscopic damage scores in all regions (rs > 0.385, P < 0.049). A significant positive correlation was observed in the left lateral region for MSS versus macroscopic damage score (rs = 0.486, P < 0.037) and MSS versus failure mode (rs = 0.724, P = 0.018, only specimens with disc failure). Pfirrmann Grade 3 discs were strongly associated with subsequent LDH (P = 0.003). CONCLUSION: Increased shear strains were observed in the contralateral side to the applied rotation as disc injury progressed from protrusion to LDH. Larger compressive loads applied to simulate unsafe lifting led to frequent early failure of the endplate, however, smaller compressive loads at similar flexion angles applied under safe lifting led to more loading cycles before failure, where the site of failure was more likely to be the disc. Our study demonstrated that unsafe lifting leads to greater risk of injury compared with safe lifting, and LDH and disc protrusion were more common in the posterior/posterolateral regions. LEVEL OF EVIDENCE: N/A.

Chromium Metal Ion Release During Instrumented Spinal Surgery in Children: The Effects of Electrosurgery.

STUDY DESIGN: Prospective 2-year study with operative sampling and in-vitro analysis of chromium ions following spinal surgery in children. OBJECTIVES: To measure metal ion levels at preoperative, intraoperative, and postoperative times to determine patterns of metal ion release during instrumented spinal surgery. SUMMARY OF BACKGROUND DATA: Raised serum metal ion levels are reported following instrumented spinal fusion in adolescent idiopathic scoliosis. The authors noted raised chromium levels in patients receiving implants that did not contain chromium. This prompted further work to establish the source. The electrosurgery tips used were discovered to contain 17% chromium. METHODS: Chromium, cobalt, and titanium levels were measured before, during, and after surgery in serum and local intraoperative fluid samples in 11 children undergoing posterior instrumentation for scoliosis. Administered drugs, cell-saver fluids, and intraoperative fluids, both local and intravenous, were investigated to exclude these as sources of chromium ions. An in-vitro study was also performed to elucidate sources of intraoperative chromium ions. RESULTS: High chromium levels were detected in all samples from the wound irrigation fluid prior to insertion of metal implants. Immediate postoperative chromium serum ion levels were also elevated and returned to baseline by day 30. In-vitro sampling of fluids from test models using electrosurgery revealed high levels of chromium ions CONCLUSION.: This finding of high chromium metal ion concentrations in intraoperative and early postoperative samples provides evidence of chromium release during the dissection phase of spinal surgery. This challenges existing beliefs that metal ion release occurs solely due to implants and now implicates the electrosurgery electrode tips as a source of raised chromium ion levels. Thorough irrigation of the operative site after the dissection phase of surgery to both dilute and reduce the intraoperative chromium ion load is suggested. Alternative electrosurgery electrode tips or other methods to coagulate during surgery could be considered. LEVEL OF EVIDENCE: 2.

Do Children With Spinal Deformity Who Have Metal Implants and Frequent Exposure to X-Rays Increase Their Risk of Cancer?

STUDY DESIGN: Spinal surgery cohort. OBJECTIVE: The authors assess the risk of cancer in children who have undergone frequent radiographs and have metal implants for the treatment of spinal deformity. SUMMARY OF BACKGROUND DATA: Concerns have been raised regarding the cancer risk to children exposed to repeated radiological examinations as part of routine surveillance to monitor progression of spinal deformity. Additionally, there are reports of increased cancer risk in adults having joint replacement with metal implants causing raised metal ion levels in the blood. METHODS: A large number of consecutive children undergoing instrumented spinal surgery since 1979 were examined for their development of malignancy. High quality data on all invasive cancers from the South Australian Cancer Registry and deaths were linked to the spinal surgery cohort with the calculation of standardized incidence ratios (SIRs) using the Quinquinquennium method. RESULTS: The study cohort was formed by 865 children. The average follow-up time from date of surgery to either death or censoring date was 18 years with a maximum of 36 years. A total of 15,921 person years were examined. There was no increased rate of cancer in these patients. For the total cohort, the SIR was 1.00 (95% confidence interval [CI] 0.50-1.79). For females the SIR was 0.83 (95% CI 0.33-1.70) and for males the SIR was 1.33 (95% CI 0.36-3.40). The male SIR reflected an expected cancer incidence of three cases, when four cases were observed, and was not statistically significant. CONCLUSION: This study has found that radiation exposure and possible exposure to circulating metal ions as a result of routine instrumented spine surgery in children since 1979 is not associated with an increased risk of cancer in up to 36 years of follow up. LEVEL OF EVIDENCE: 2.

Cauda Equina Syndrome Core Outcome Set (CESCOS): An international patient and healthcare professional consensus for research studies.

BACKGROUND: Cauda Equina Syndrome (CES) is an emergency condition that requires acute intervention and can lead to permanent neurological deficit in working age adults. A Core Outcome Set (COS) is the minimum set of outcomes that should be reported by a research study within a specific disease area. There is significant heterogeneity in outcome reporting for CES, which does not allow data synthesis between studies. The hypothesis is that a COS for CES can be developed for future research studies using patients and healthcare professionals (HCPs) as key stakeholders. METHODS AND FINDINGS: Qualitative semi-structured interviews with CES patients were audio-recorded, transcribed and analysed using NVivo to identify the outcomes of importance. These were combined with the outcomes obtained from a published systematic literature review of CES patients. The outcomes were grouped into a list of 37, for rating through two rounds of an international Delphi survey according to pre-set criteria. The Delphi survey had an overall response rate of 63% and included 172 participants (104 patients, 68 HCPs) from 14 countries who completed both rounds. Thirteen outcomes reached consensus at the end of the Delphi survey and there was no attrition bias detected. The results were discussed at an international consensus meeting attended by 34 key stakeholders (16 patients and 18 HCPs) from 8 countries. A further three outcomes were agreed to be included. There was no selection bias detected at the consensus meeting. There are 16 outcomes in total in the CESCOS. DISCUSSION: This is the first study in the literature that has determined the core outcomes in CES using a transparent international consensus process involving healthcare professionals and CES patients as key stakeholders. This COS is recommended as the most important outcomes to be reported in any research study investigating CES outcomes and will allow evidence synthesis in CES.

A braced arm-to-thigh (BATT) lifting technique reduces lumbar spine loads in healthy and low back pain participants.

Despite the common use of one-handed lifting techniques for activities of daily living, these techniques have received little attention in the biomechanics literature. The braced arm-to-thigh technique (BATT) is a one-handed lifting method in which the dominant hand picks up objects, while the free hand braces the trunk on the ipsilateral thigh. The aim of this study was to compare the BATT to two-handed or unsupported one-handed lifting techniques with loads of 2 and 10 kg, by evaluating trunk motion and spine loading at L4/L5. Twenty healthy participants (30-70 years old) matched in age and sex to 18 participants with low back pain were recruited to the study. A three-axis load cell secured to the distal anterior thigh measured the bracing forces applied by the hand. The OpenSim Lifting Full-Body model was used to estimate trunk kinematics and spinal loading at L4/L5. Linear mixed-effects models were developed to compare trunk angles and L4/L5 moments and forces between lifting techniques. Trunk flexion angles were significantly reduced for the BATT lift compared to one-handed and two-handed stoop lifts (9-20%). However, the BATT also increased asymmetric trunk kinematics and moments at L4/L5. The BATT produced significantly lower moments (28-38%), and compressive (25-32%) and antero-posterior shear (25-45%) forces at L4/L5, compared to unsupported lifting techniques. Bracing the hand on the thigh to support the trunk can substantially reduce low back loading during lifting tasks of 2 to 10 kg.

The effect of axial compression and distraction on cervical facet mechanics during anterior shear, flexion, axial rotation, and lateral bending motions.

The subaxial cervical facets are important load-bearing structures, yet little is known about their mechanical response during physiological or traumatic intervertebral motion. Facet loading likely increases when intervertebral motions are superimposed with axial compression forces, increasing the risk of facet fracture. The aim of this study was to measure the mechanical response of the facets when intervertebral axial compression or distraction is superimposed on constrained, non-destructive shear, bending and rotation motions. Twelve C6/C7 motion segments (70 ±â€¯13 yr, nine male) were subjected to constrained quasi-static anterior shear (1 mm), axial rotation (4°), flexion (10°), and lateral bending (5°) motions. Each motion was superimposed with three axial conditions: (1) 50 N compression; (2) 300 N compression (simulating neck muscle contraction); and, (3) 2.5 mm distraction. Angular deflections, and principal and shear surface strains, of the bilateral C6 inferior facets were calculated from motion-capture data and rosette strain gauges, respectively. Linear mixed-effects models (α = 0.05) assessed the effect of axial condition. Minimum principal and maximum shear strains were largest in the compressed condition for all motions except for maximum principal strains during axial rotation. For right axial rotation, maximum principal strains were larger for the contralateral facets, and minimum principal strains were larger for the left facets, regardless of axial condition. Sagittal deflections were largest in the compressed conditions during anterior shear and lateral bending motions, when adjusted for facet side.

Validation of an OpenSim full-body model with detailed lumbar spine for estimating lower lumbar spine loads during symmetric and asymmetric lifting tasks.

There is currently no validated full-body lifting model publicly available on the OpenSim modelling platform to estimate spinal loads during lifting. In this study, the existing full-body-lumbar-spine model was adapted and validated for lifting motions to produce the lifting full-body model. Back muscle activations predicted by the model closely matched the measured erector spinae activation patterns. Model estimates of intradiscal pressures and in vivo measurements were strongly correlated. The same spine loading trends were observed for model estimates and reported vertebral body implant measurements. These results demonstrate the suitability of this model to evaluate changes in lumbar loading during lifting.

Does nanoscale porous titanium coating increase lumbar spinal stiffness of an interbody fusion cage? An in vivo biomechanical analysis in an ovine model.

BACKGROUND: Quantitative objective measures to determine fusion achievement further enable the comparison of new technologies, such as interbody cage surface enhancement. Our aims were to compare in vivo biomechanical responses of ovine L4/5 lumbar motion segments with two cages: 1) Polyetheretherketone or 2) Polyetheretherketone with a nanosurfaced titanium porous scaffold from Nanovis, Inc. METHODS: Fourteen Merino sheep randomly received either 1) standard Polyetheretherketone cage or 2) Nanocoated Polyetheretherketone cage at L4/L5 with autologous bone graft. At baseline and one-year follow-up, dynamic spinal stiffness was quantified in vivo using a validated mechanical assessment at 2 Hz, 6 Hz, and 12 Hz. The dorsoventral secant stiffness (ky = force/displacement, N/mm) and L4-L5 accelerations were determined at each frequency. A repeated measures analysis of variance with Bonferonni correction was used to evaluate within and between group differences among the biomechanical variables. FINDINGS: Both implants increased spinal stiffness at 2 Hz (21 and 39%, respectively, p < .005), and at 6 Hz (12 and 27%, p < .0001). Significantly greater spinal stiffness was observed with Nanocoated Polyetheretherketone at one-year for both frequencies (p < .05). No significant differences were observed at 12 Hz within or between groups. L4-L5 dorsoventral accelerations were significantly decreased one year following cage placement only with Nanocoated Polyetheretherketone (p < .05) and greater reductions in acceleration were observed with Nanocoated Polyetheretherketone compared to standard Polyetheretherketone (p < .05). INTERPRETATION: Both cages increased spinal stiffness, yet, nanosurfaced cages resulted in greater spinal stiffness changes and decreases in L4-L5 accelerations. These findings may assist in clinical decision making and post-operative recovery strategies.

Intradiscal electrothermal therapy, percutaneous discectomy, and nucleoplasty: what is the current evidence?

Over the past decade, there has been a surge of minimally invasive techniques aimed at treating both discogenic low back pain (LBP) and radicular pain. This article assesses the current evidence for three such treatments: intradiscal electrothermal therapy (IDET), percutaneous discectomy, and nucleoplasty. An electronic search of the literature carried out using the Cochrane Library database (2007) and Medline (1966-2007) identified 77 references relating to IDET, 363 to percutaneous discectomy, and 36 to nucleoplasty. Two randomized controlled trials (RCTs) assessed the effectiveness of IDET; one demonstrated a positive effect on pain severity only, whereas the other demonstrated no substantial benefit. Other RCTs show that percutaneous intradiscal radiofrequency thermocoagulation is ineffective for the treatment of discogenic LBP. Trials of automated percutaneous discectomy suggest that clinical outcomes after treatment are at best fair and often worse when compared with microdiscectomy. There are no published RCTs assessing Coblation (ArthroCare Spine, Stockholm, Sweden) technology.

Concepts on the pathogenesis of adolescent idiopathic scoliosis. Bone growth and mass, vertebral column, spinal cord, brain, skull, extra-spinal left-right skeletal length asymmetries, disproportions and molecular pathogenesis.

There is no generally accepted scientific theory for the causes of adolescent idiopathic scoliosis (AIS). Encouraging advances thought to be related to AIS pathogenesis have recently been made in several fields including anthropometry of bone growth, bone mass, spinal growth modulation, extra-spinal left-right skeletal length asymmetries and disproportions, magnetic resonance imaging of vertebral column, spinal cord, brain, skull, and molecular pathogenesis. These advances are leading to the evaluation of new treatments including attempts at minimally invasive surgery on the spine and peri-apical ribs. Several concepts of AIS are outlined indicating their clinical applications but not their research potential. The concepts, by derivation morphological, molecular and mathematical, are addressed in 15 sections: 1) initiating and progressive factors; 2) relative anterior spinal overgrowth; 3) dorsal shear forces that create axial rotational instability; 4) rotational preconstraint; 5) uncoupled, or asynchronous, spinal neuro-osseous growth; 6) brain, nervous system and skull; 7) a novel neuro-osseous escalator concept based on a putative abnormality of two normal polarized processes namely, a) increasing skeletal dimensions, and b) the CNS body schema - both contained within a neuro-osseous timing of maturation (NOTOM) concept; 8) transverse plane pelvic rotation, skeletal asymmetries and developmental theory; 9) thoraco-spinal concept; 10) origin in contracture at the hips; 11) osteopenia; 12) melatonin deficiency; 13) systemic melatonin-signaling pathway dysfunction; 14) platelet calmodulin dysfunction; and 15) biomechanical spinal growth modulation. From these concepts, a collective model for AIS pathogenesis is formulated. The central concept of this model includes the body schema of the neural systems, widely-studied in adults, that control normal posture and coordinated movements with frames of reference in the posterior parietal cortex. The escalator concept has implications for the normal development of upright posture, and the evolution in humans of neural control, the trunk and unique bipedal gait.