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A prospective, randomized, controlled study was carried out to compare the radiological and clinical outcomes after anterior cervical decompression and fusion (ACDF) with Trabecular Metal (TM) to the traditional Smith-Robinson (SR) procedure with autograft. The clinical results of cervical fusion with autograft from the iliac crest are typically satisfactory, but implications from the donor site are frequently reported. Alternative materials for cervical body interfusion have shown lower fusion rates. Trabecular Metal is a porous tantalum biomaterial with structure and mechanical properties similar to that of trabecular bone and with proven osteoconductivity. As much as 80 consecutive patients planned for ACDF were randomized for fusion with either TM or tricortical autograft from the iliac crest (SR) after discectomy and decompression. Digitized plain radiographic images of 78 (98%) patients were obtained preoperatively and at 2-year follow-up and were subsequently evaluated by two senior radiologists. Fusion/non-fusion was classified by visual evaluation of the A-P and lateral views in forced flexion/extension of the cervical spine and by measuring the mobility between the fused vertebrae. MRI of 20 TM cases at 2 years was successfully used to assess the decompression of the neural structures, but was not helpful in determining fusion/non-fusion. Pain intensity in the neck, arms and pelvis/hip were rated by patients on a visual analog scale (VAS) and neck function was rated using the Neck Disability Index (NDI) the day before surgery and 4, 12 and 24 months postoperatively. Follow-ups at 12 and 24 months were performed by an unbiased observer, when patients also assessed their global outcome. Fusion rate in the SR group was 92%, and in the TM group 69% (P < 0.05). The accuracy of the measurements was calculated to be 2.4 degrees . Operating time was shorter for fusion with TM compared with autograft; mean times were 100 min (SD 18) and 123 min (SD 23), respectively (P = 0.001). The patients' global assessments of their neck and arm symptoms 2 years postoperatively for the TM group were rated as 79% much better or better after fusion with TM and 75% using autograft. Pain scores and NDI scores were significantly improved in both groups when compared with baseline at all follow-ups, except for neck pain at 1 year for the TM group. There was no statistically significant difference in clinical outcomes between fusion techniques or between patients who appeared radiologically fused or non-fused. There was no difference in pelvic/hip pain between patients operated on with or without autograft. In our study, Trabecular Metal showed a lower fusion rate than the Smith-Robinson technique with autograft after single-level anterior cervical fusion without plating. There was no difference in clinical outcomes between the groups. The operative time was shorter with Trabecular Metal implants. [ABSTRACT FROM AUTHOR]

South Korea, Singapore and Taiwan are well known as export-oriented developmental states which for decades employed industrial policy to target particular industries for government support. In the past fifteen years, these three countries all identified the biopharmaceutical industry as a strategic sector. This article explores, through economic analysis, the rationale for this decision and the strategies chosen for linking into the global bio-economy with the objective of catching up in biopharmaceuticals. The paper identifies three comparative advantages enjoyed by these countries in the biopharma sector: (1) public investments in basic research; (2) private investments in phase 1 clinical trials; and (3) a potentially significant contract research industry managing latter-stage clinical trials. Governments employ a range of industrial policies, consistent with these comparative advantages, to promote the biopharmaceutical industry, including public investment in biomedical hubs, research funding and research and development (R&D) tax credits. We argue that the most important feature of the biopharmaceutical industry in these countries is the dominant role of the public sector. That these countries have made progress in innovative capabilities is illustrated by input measures such as R&D expenditure as share of gross domestic product, number of patents granted and clinical trials, and volume of foreign direct investment. In contrast, output indicators such as approval of new chemical entities suggest that the process of catching up has only just commenced. Pharmaceutical innovation is at the stage of mainly generating inputs to integrated processes controlled by the globally incumbent firms. [ABSTRACT FROM AUTHOR]

The problem of determining the noise level in any measuring system remains urgent. Radiostereometric analysis (RSA) is a radiographic system of unique accuracy which has applications in areas where minute motions or no motion at all occurs. Examples are micromotion between endoprostheses and bone and in fracture healing. We have determined the accuracy of the RSA system as applied to a clinical series of spinal fusions, where the conditions for RSA were not optimal. Using the usual test-retest methodology on a phantom, we showed that its accuracy can be grossly overestimated in the individual case. We found considerable variations in the accuracy in the individual case, depending on the rigid-body configuration. The overall accuracy, expressed as 3-D 'vectors' for rotation and translation, respectively, correlated with the condition number, a method for characterizing the marker configuration. Indeed, the condition number explained as much as 92% of the variation in overall rotation. This condition number, however, cannot be used to analyze the accuracy of one degree of freedom of rotation alone. Mathematical simulation of the accuracy in the individual case of the individual dimension, using in-house software, showed that the accuracy (95% confidence) varied between 0.4 and 4.6 degrees of rotation about the transverse axis, corresponding to a clinical stress series of extension and flexion. [ABSTRACT FROM AUTHOR]

The Power Control and Distribution Unit (PCDU) described in this paper is a custom design for the InnoSat satellite platform. Particular attention is given to the architecture, design techniques and general failure mitigation approach that has been adopted to meet the low cost constraints of the platform while maintaining reliability for its entire mission lifetime. A point of importance is the scalability of the design in order to meet different payload power demands from mission to mission while minimizing NRE work. The very important areas of component selection, testing and qualification are also described. In order to quantify some of the topics discussed, the description is mostly focused on the PCDU of the first InnoSat based satellite named MATS and which is expected for launch at 2018.

Purpose: To compare the patient-derived modified Japanese Orthopaedic Association (P-mJOA) scale with the European myelopathy score (EMS) for the assessment of patients with degenerative cervical myelopathy (DCM)., Methods: In this register-based cohort study with prospectively collected data, included patients were surgically treated for DCM and had reported both P-mJOA and EMS scores at baseline, 1-year follow-up, and/or 2-year follow-up to the Swedish Spine Register. P-mJOA and EMS scores were defined as severe (P-mJOA 0-11 and EMS 5-8), moderate (P-mJOA 12-14 and EMS 9-12), or mild (P-mJOA 15-18 and EMS 13-18). P-mJOA and EMS mean scores were compared, and agreement was evaluated with Spearman's rank correlation coefficient (ρ), the intraclass correlation coefficient (ICC), and kappa (κ) statistics., Results: Included patients (n = 714, mean age 63.2 years, 42.2% female) completed 937 pairs of the P-mJOA and the EMS. The mean P-mJOA and EMS scores were 13.9 ± 3.0 and 14.5 ± 2.7, respectively (mean difference -0.61 [95% CI -0.72 to -0.51; p < 0.001]). Spearman's ρ was 0.84 (p < 0.001), and intra-rater agreement measured with ICC was 0.83 (p < 0.001). Agreement of severity level measured with unweighted and weighted κ was fair (κ = 0.22 [p < 0.001]; κ = 0.34 [p < 0.001], respectively). Severity levels were significantly higher using the P-mJOA (p < 0.001)., Conclusion: The P-mJOA and the EMS had similar mean scores, and intra-rater agreement was high, whereas severity levels only demonstrated fair agreement. The EMS has a lower sensitivity for detecting severe myelopathy but shows an increasing agreement with the P-mJOA for milder disease severity. A larger interval to define severe myelopathy with the EMS is recommended., (© 2023. The Author(s).)

Background: Dizziness and balance problems are common symptoms in patients with cervical radiculopathy., Objective: To evaluate the effect of neck surgery postoperatively combined with either structured rehabilitation or standard approach in patients with cervical radiculopathy and dizziness and/or balance problems, and investigate factors influencing dizziness and balance at 6-month follow-up., Methods: Individuals (n = 149) with cervical radiculopathy and dizziness and/or balance problems were randomized preoperatively to structured postoperative rehabilitation or standard postoperative approach. Outcomes were intensity of dizziness and subjective balance, and clinical measures of balance., Results: Self-reported measures improved at three months (p ˂ 0.001 to p = .007) and the standing balance at six months (p = .008). No between-group differences. Baseline values, neck pain, and physical activity level explained 23-39% of the variance in 6-month outcomes for self-reported measures. Baseline values and physical activity level explained 71% of the variance in walking balance, and lower baseline scores were significantly associated with standing balance impairments (OR 0.876)., Conclusion: Patients improved significantly in dizziness and subjective balance intensity shortly after surgery, and in standing balance at 6 months, independent of postoperative rehabilitation. Neck pain, physical activity, and neck muscle function influenced dizziness and balance, although preoperative values and neck pain were of most importance for 6-month outcomes.

Reports on neurological outcomes in patients with cervical radiculopathy (CR) undergoing surgery and postoperative rehabilitation are important to inform prognosis. This 2-year-follow-up of a randomized clinical trial aimed to compare secondary neurological outcomes between structured postoperative rehabilitation and a standard approach after surgery for CR. A secondary aim was to increase knowledge about recovery of neurological impairments in relation to patient-reported neck disability. Neurological outcomes included assessment of sensibility, motor function, arm reflexes and the Spurling test. A total of 153 and 135 participants (> 70% response rate) completed the clinical examination. Between-group differences, changes over time, and associations between persistent neurological impairments and the Neck Disability Index were investigated. No between-group differences were reported (p > 0.07), and neurological impairments in sensibility, motor function, and a positive Spurling test decreased over time in both groups (p < 0.04). Persistent impairments in sensibility and reflex arm were most frequent at follow-up, whereas, a persistent positive Spurling test, and impairments in motor function were associated with higher NDI score. Neurological outcomes improved over time in patients undergoing surgery for CR with no between-group differences., However, persistent neurological impairments were common, and associated with poorer outcome for patient-reported neck disability.Clinical registration: clinicaltrial.gov NCT01547611, 08/03/2012, Title: Outcome of physiotherapy after surgery for cervical disc disease: a prospective multi-centre trial., (© 2023. The Author(s).)

Background: Cervical spondylotic myelopathy (CSM) is the predominant cause of spinal cord dysfunction in the elderly. The patients are often frail and susceptible to complications. Posterior surgical techniques involving non-fusion are complicated by postlaminectomy kyphosis and instrumented fusion techniques by distal junction kyphosis, pseudarthrosis, or implant failure. The optimal surgical approach is still a matter of controversy. Since anterior and posterior fusion techniques have been compared without presenting any superiority, the objective of this study is to compare stand-alone laminectomy with laminectomy and fusion to determine which treatment has the lowest frequency of reoperations., Methods: This is a multicenter randomized, controlled, parallel-group non-inferiority trial. A total of 300 adult patients are allocated in a ratio of 1:1. The primary endpoint is reoperation for any reason at 5 years of follow-up. Sample size and power calculation were performed by estimating the reoperation rate after laminectomy to 3.5% and after laminectomy with fusion to 7.4% based on the data from the Swedish spine registry (Swespine) on patients with CSM. Secondary outcomes are the patient-derived Japanese Orthopaedic Association (P-mJOA) score, Neck Disability Index (NDI), European Quality of Life Five Dimensions (EQ-5D), Numeric Rating Scale (NRS) for neck and arm pain, Hospital Anxiety and Depression Scale (HADS), development of kyphosis measured as the cervical sagittal vertical axis (cSVA), and death. Clinical and radiological follow-up is performed at 3, 12, 24, and 60 months after surgery. The main inclusion criterium is 1-4 levels of CSM in the subaxial spine, C3-C7. The REDcap software will be used for safe data management. Data will be analyzed according to the modified intention to treat (mITT) population, defined as randomized patients who are still alive without having emigrated or left the study after 2 and 5 years., Discussion: This will be the first randomized controlled trial comparing two of the most common surgical treatments for CSM: the posterior muscle-preserving selective laminectomy and posterior laminectomy with instrumented fusion. The results of the myelopathy randomized controlled (MyRanC) study will provide surgical treatment recommendations for CSM. This may result in improvements in surgical treatment and clinical practice regarding CSM., Trial Registration: ClinicalTrials.gov NCT04936074 . Registered on 23 June 2021., (© 2023. The Author(s).)

Background and Aims: Pain drawings are commonly used in the clinical assessment of people with cervical radiculopathy. This study aimed to assess (1) the agreement of clinical interpretation of pain drawings and MRI findings in identifying the affected level of cervical radiculopathy, (2) the agreement of these predictions based on the pain drawing among four clinicians from two different professions (i.e., physiotherapy and surgery) and (3) the topographical pain distribution of people presenting with cervical radiculopathy (C4-C7)., Methods: Ninety-eight pain drawings were obtained from a baseline assessment of participants in a randomized clinical trial, in which single-level cervical radiculopathy was determined using MRI. Four experienced clinicians independently rated each pain drawing, attributing the pain distribution to a single nerve root (C4-C7). A post hoc analysis was performed to assess agreement., Outcome Measures: Percentage agreement and kappa values were used to assess the level of agreement. Topographic pain frequency maps were created for each cervical radiculopathy level as determined by MRI., Results: The radiculopathy level determined from the pain drawings showed poor overall agreement with MRI (mean = 35.7%, K = -0.007 to 0.139). The inter-clinician agreement ranged from fair to moderate (K = 0.212-0.446). Topographic frequency maps revealed that pain distributions were widespread and overlapped markedly between patients presenting with different levels cervical radiculopathy., Conclusion: This study revealed a lack of agreement between the segmental level affected determined from the patient's pain drawing and the affected level as identified on MRI. The large overlap of pain and non-dermatomal distribution of pain reported by patients likely contributed to this result., (© 2022 The Authors. Pain Practice published by Wiley Periodicals LLC on behalf of World Institute of Pain.)