European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
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Clinical Trial
Anterior vertebral body replacement with a titanium implant of adjustable height: a prospective clinical study.
In the operative treatment of spinal injuries, the reconstruction of the anterior column of the thoracolumbar spine is still controversial. We conducted a prospective clinical study to investigate the clinical and radiological outcome of 50 patients treated with a vertebral body replacement of adjustable height (Synex). Fifty consecutive patients were evaluated during in-patient treatment and at 12 and 20 months post-operatively in clinical notes and radiographs. 38/50 patients were operated for traumatic fractures. ⋯ The loss of correction or reduction was only minimal. On the basis of our results we recommend the Synex implant as an alternative for the fixation and stabilisation of thoracolumbar fractures. However, long-term results and a clinically random control study are still required.
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Randomized Controlled Trial Comparative Study
Assessment of CAOS as a training model in spinal surgery: a randomised study.
The objectives of this study were (1) to quantify the benefit of computer assisted orthopaedic surgery (CAOS) pedicle screw insertion in a porcine cadaver model evaluated by dissection and computed tomography (CT); (2) to compare the effect on performance of four surgeons with no experience of CAOS, and varying experience of pedicle screw insertion; (3) to see if CT with extended windows was an acceptable method to evaluate the position of the pedicle screws in the porcine cadaver model, compared to dissection. This was a prospective, randomised, controlled and blinded porcine cadaver study. Twelve 6-month-old porcine (white skinned Landrace) lumbar spines were scanned pre-operatively by spiral CT, as required for the CAOS computer data set. ⋯ The experienced general orthopaedic surgeon did not benefit from CAOS (P = 0.5). CT compared to dissection showed an intra-observer reliability of 99.4% and inter-observer reliability of 92.6%. The conclusions of this study were as follows: (1) an increased number of pedicle screws were ideally placed using the CAOS electromagnetic guidance system compared to the conventional freehand technique; (2) junior surgeons benefited most from CAOS; (3) we believe CAOS (Navitrak) with porcine lumbar spines evaluated by post operative CT, represents a useful model for training junior surgeons in pedicle screw placement; (4) experienced spine surgeons, who have never used CAOS, may find CAOS less helpful than previously reported.
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Randomized Controlled Trial
Randomised placebo-controlled trial on the effectiveness of nasal salmon calcitonin in the treatment of lumbar spinal stenosis.
This is a double blind randomised controlled trial to assess the effectiveness of nasal salmon calcitonin in the treatment of lumbar spinal stenosis. The trial compared the outcome of salmon calcitonin nasal spray to placebo nasal spray in patients with MRI confirmed lumbar spinal stenosis. Lumbar spinal stenosis is one of the commonest conditions encountered by spine surgeons. ⋯ There was no significant difference in walking distance between the two groups, with a mean improvement in walking distance of 21 m in the calcitonin group and 8 m in the placebo group (P = 0.78). At the end of the trial the ODI had improved by a mean of 3.7 points in the calcitonin group and 3.8 points in the placebo group (P = 0.44). This randomised placebo controlled trial has not shown any treatment effect in patients with lumbar spinal stenosis treated with nasal salmon calcitonin.
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Although the effect of physical workload on the occurrence of low back pain (LBP) has been extensively investigated, few quantitative studies have examined the morphological changes visualized via magnetic resonance imaging (MRI) in relation to occupational variables. The relationship between the severity of some abnormalities such as lumbar spinal stenosis or spondylolisthesis and physical or psychosocial occupational risk factors has not been investigated previously. In this cross-sectional study patients fulfilled the following inclusion criteria: (1) long-standing (minimum 1-year) LBP radiating down the leg (or not); (2) age more than 40 years; (3) willingness to undergo an MRI of the lumbar spine; and (4) ability to speak Italian. ⋯ A heavier job workload was the only occupational factor positively related to the degree of disability at the multivariate analysis (P=0.002). Total amount of degeneration in the lumbar spine directly influenced pain duration (P=0.011) and degree of disability (P=0.050). These results suggest that caution should be exercised when symptomatic subjects with evidence of degenerative changes on MRI scans engage in strenuous physical labor.
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Clinical Trial
The effect of duration of symptoms on standard outcome measures in the surgical treatment of spinal stenosis.
The effect of the duration of symptoms on the outcome of lumbar decompression surgery is not known. The aim of our study was to determine the predictors of functional outcome of lumbar decompression surgery for degenerative spinal stenosis with particular emphasis on the duration of symptoms. In this prospective cohort study, we recruited 100 patients with a full data set available at 1-year and 85% at 2-year follow-ups: 49 females and 51 males with an average age of 62 (range 52-82). ⋯ We have not found a predictive value for age at operation, MSP or MZD. The number of levels of decompression and the different types of decompression surgery did not influence the surgical results. Our study indicates that the symptom duration of more than 33 months has a less favourable functional outcome.