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
Balloon kyphoplasty in the treatment of metastatic disease of the spine: a 2-year prospective evaluation.
There is currently little data on the longer term efficacy and safety of balloon kyphoplasty (BKP) in patients with metastatic vertebral compression fractures (VCFs). To prospectively assess the long-term efficacy and safety of BKP in treating thoracic and lumbar spinal metastatic fractures that result in pain or instability. Sixty-five patients (37 men, mean age: 66 years) underwent 99 BKP procedures. ⋯ No symptomatic cement leaks or serious adverse events were seen during the 24 months of follow up. BKP is a minimally invasive procedure that provides immediate and long-term pain relief and improvement in functional ability in selected patients with metastatic VCFs. The procedure appears to have good long-term safety.
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The nonsurgical treatment of thoracolumbar (TLB) and lumbar burst (LB) fractures remains to be of interest, though it is not costly and avoids surgical risks. However, a subset of distinct burst fracture patterns tend to go with a suboptimal radiographic and clinical long-term outcome. Detailed fracture pattern and treatment-related results in terms of validated outcome measures are still lacking. ⋯ But, the interdependence of spinopelvic parameters was not disrupted. The patients' spinal adaptability to compensate for the posttraumatic kyphotic deformity varied in the ranges dictated by pelvic geometry, in particular the pelvic incidence. The study substantiates the concept that surgical reconstruction and maintenance of a physiologically shaped spinal curve might be the appropriate treatment in the more severely crushed TLB and LB fractures.
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Undercutting decompression is a common surgical procedure for the therapy of lumbar spinal canal stenosis. Segmental instability, due to segmental degeneration or iatrogenic decompression is a typical problem that is clinically addressed by fusion, or more recently by semi-rigid stabilization devices. The objective of this experimental biomechanical study was to investigate the influence of spinal decompression alone, as well as in conjunction with two semi-rigid stabilizing implants (Wallis, Dynesys) on the range of motion (ROM) of lumbar spine segments. ⋯ Wallis and Dynesys restrict not only isolated extension, but also flexion. These biomechanical results support the hypothesis that postoperatively, the semi-rigid implants provide a primary stabilizing function directly. Whether they can improve the clinical outcome must still be verified in prospective clinical investigations.
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Review
Imperfect placebos are common in low back pain trials: a systematic review of the literature.
The placebo is an important tool to blind patients to treatment allocation and therefore minimise some sources of bias in clinical trials. However, placebos that are improperly designed or implemented may introduce bias into trials. The purpose of this systematic review was to evaluate the adequacy of placebo interventions used in low back pain trials. ⋯ Taken together, these results demonstrate that imperfect placebos are common in low back pain trials; a result suggesting that many trials provide potentially biased estimates of treatment efficacy. This finding has implications for the interpretation of published trials and the design of future trials. Implementation of strategies to facilitate blinding and balance expectations in randomised groups need a higher priority in low back pain research.