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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Randomized Controlled Trial
A prospective randomised study on the long-term effect of lumbar fusion on adjacent disc degeneration.
The existence and importance of an accelerated adjacent segment disc degeneration (ASD) after lumbar fusion have previously not been demonstrated by RCTs. The objectives of this study were, to determine whether lumbar fusion in the long term accelerates degenerative changes in the adjacent disc and whether this affects the outcome, by using a prospective randomised design. A total of 111 patients, aged 18-55, with isthmic spondylolisthesis were randomised to exercise (EX, n = 34) or posterolateral fusion (PLF, n = 77), with (n = 37) or without pedicle screw instrumentation (n = 40). ⋯ In conclusion, the long-term RCT shows that fusion accelerates degenerative changes at the adjacent level compared with natural history. The study suggests that not only fusion, but also laminectomy may be of pathogenetic importance. The clinical importance of ASD seems limited, with only the more severe forms affecting the outcome.
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The Swedish Spine Register enables monitoring of surgical activities focusing on changes in trends over time, techniques utilized and outcome, when implemented in general clinical practice. Basic requirements for a prosperous register are unity within the profession, mainly patient-based documentation and a well functioning support system. This presentation focuses on the development and design of the register protocol, problems encountered and solutions found underway. ⋯ Over the last 10 years, surgical treatment for spinal stenosis has increased gradually while disc herniation surgery decreases regarding yearly number of procedures. An added function to the register enables more complex prospective clinical studies to include register data together with data suitable for the individual study. A common core set of demographic, surgical and outcome parameters would enable comparisons of clinical studies within and between nations.
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Randomized Controlled Trial
Perioperative and short-term advantages of mini-open approach for lumbar spinal fusion.
It has been widely reported a vascular and neurologic damage of the lumbar muscles produced in the classic posterior approach for lumbar spinal fusions. The purpose of this study is to demonstrate a better clinical and functional outcome in the postoperative and short term in patients undergoing minimal invasive surgery ("mini-open") for this lumbar spinal arthrodesis. We designed a prospective study with a 30 individuals cohort randomized in two groups, depending on the approach performed to get a instrumented lumbar circumferential arthrodesis: "classic posterior" (CL group) or "mini-open" approach (MO group). ⋯ No significant differences were found between two groups in surgery timing, X-rays exposure or sciatic postoperative pain. This study, inline with previous investigations, reinforces the concept of minimizing the muscular lumbar damage with a mini-open approach for a faster and better recovery of patients' disability in the short term. Further investigations are necessary to confirm these findings in the long term, and to verify the achievement of a stable lumbar spinal fusion.
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The randomized controlled trial (RCT) is generally accepted as the most reliable method of conducting clinical research. To obtain an unbiased evaluation of the effectiveness of spine surgery, patients should be randomly assigned to either new or standard treatment. The aim of the present article is to provide a short overview of the advantages and challenges of RCTs and to present a summary of the conclusions of the Cochrane Reviews in spine surgery and later published trials in order to evaluate their contribution to quality management and feasibility in practice. ⋯ The only intervention that receives strong evidence is discectomy for faster relief in carefully selected patients due to lumbar disc prolapse with sciatica. For future trials, authors, referees, and editors are recommended to follow the CONSORT statement. RCTs provide evidence to support clinical opinions before implementation of new techniques, but the individual clinical experience is still important for the doctor who has to face the patient.
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Approximately one million spinal surgeries are performed in the United States each year. The risk of an incidental durotomy (ID) and resultant persistent cerebrospinal fluid (CSF) leakage is a significant concern for surgeons, as this complication has been associated with increased length of hospitalization, worse neurological outcome, and the development of CSF fistulae. Augmentation of standard dural suture repair with the application of fibrin glue has been suggested to reduce the frequency of these complications. ⋯ There were no complications associated with the use of fibrin glue. A history of prior surgery significantly increases the incidence of durotomy during elective lumbar spine surgery. In patients who experienced a durotomy during lumbar spine surgery, the use of fibrin glue for dural repair did not significantly decrease the incidence of a persistent CSF leak.