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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Multicenter Study Comparative Study
Incidental durotomy in lumbar spine surgery: incidence and management.
There is increasing awareness of the need to inform patients of common complications that occur during surgical procedures. During lumbar spine surgery, incidental tear of the dural sac and subsequent cerebrospinal fluid leak is possibly the most frequently occurring complication. There is no consensus in the literature about the rate of dural tears in spine surgery. ⋯ The rate was 3.5% for primary discectomy, 8.5% for spinal stenosis surgery and 13.2% for revision discectomy. There was a wide variation in the actual and estimated rates of dural tears among the spine surgeons. The results confirm that prospective data collection by spine surgeons is the most efficient and accurate way to assess complication rates for spinal surgery.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A prospective randomized multi-center study for the treatment of lumbar spinal stenosis with the X STOP interspinous implant: 1-year results.
Patients suffering from neurogenic intermittent claudication secondary to lumbar spinal stenosis have historically been limited to a choice between a decompressive laminectomy with or without fusion or a regimen of non-operative therapies. The X STOP Interspinous Process Distraction System (St. Francis Medical Technologies, Concord, Calif.), a new interspinous implant for patients whose symptoms are exacerbated in extension and relieved in flexion, has been available in Europe since June 2002. ⋯ Using the ZCQ criteria, at 6 weeks the success rate was 52% for X STOP patients and 10% for NON OP patients. At 6 months, the success rates were 52 and 9%, respectively, and at 1 year, 59 and 12%. The results of this prospective study indicate that the X STOP offers a significant improvement over non-operative therapies at 1 year with a success rate comparable to published reports for decompressive laminectomy, but with considerably lower morbidity.
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Review Multicenter Study Guideline
Classification and management of early complications in open lumbar microdiscectomy.
Complications and side effects in any kind of surgery, especially in spine surgery, should be evaluated to prevent those problems in the future. Since retrospective studies are of minor value and randomized controlled studies for complications are impossible to perform because of ethical and legal reasons, so-called "expert opinion" has to take their place in evidence-based medicine. On the basis of an analysis of the results of three spine centers together with the opinions of experienced spine surgeons, the authors have drawn up a classification of complications in open lumbar disc surgery and recommendations on how to manage common complications such as excessive bleeding, dural opening, nerve root lesions and recurrent disc herniation. The management of intraoperative complications should have the same training in microdiscectomy instructional courses as the operation itself.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Complications in lumbar fusion surgery for chronic low back pain: comparison of three surgical techniques used in a prospective randomized study. A report from the Swedish Lumbar Spine Study Group.
The reported complication rates after various surgical techniques used to create a lumbar fusion vary within wide ranges. In a previous paper, the Swedish Lumbar Spine Study Group have reported on the clinical outcome of lumbar spine fusion for chronic low back pain in a comparably homogeneous patient population where there were no significant differences between baseline sociodemographic, clinical and paraclinical characteristics. In this report we compared the complication rates of the surgical procedures used in that study and analyzed the association between complications and baseline variables, and between outcome results and complications. ⋯ Even though we did not find a significant association between clinical outcome and complications after 2 years, the increased morbidity inflicted on an individual patient was not negligible. In this light, and as no fusion technique produced superior clinical outcome irrespective of whether complications were included or excluded in the analyses, the patient and the treating physician should carefully discuss the possible advantages and drawbacks of the different surgical options before making a decision. In order to make valid comparisons of both complication and reintervention rates after lumbar fusion, there is a need for a consensus in the spinal society regarding the definition of these entities.
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Multicenter Study Clinical Trial
The dynamic neutralization system for the spine: a multi-center study of a novel non-fusion system.
Various forms of lumbar instability require a surgical stabilization. As an alternative to fusion, a mobile, dynamic stabilization restricting segmental motion would be advantageous in various indications, allowing greater physiological function and reducing the inherent disadvantages of rigid instrumentation and fusion. The dynamic neutralization system for the spine (Dynesys) is a pedicle screw system for mobile stabilization, consisting of titanium alloy screws connected by an elastic synthetic compound, controlling motion in any plane (non-fusion system). ⋯ Long-term screw fixation is dependent on correct screw dimension and proper screw positioning. The natural course of polysegmental disease in some cases necessitates further surgery as the disease progresses. Dynamic neutralization proved to be a safe and effective alternative in the treatment of unstable lumbar conditions.