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Shared Interests Group

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The evaluation of possible improvements of surgical treatment of spinal disorders has historically been insufficient. In recent years it has become widely recognized that properly conducted trials, which follow the principles of scientific experiments, provide a reliable platform in the evaluation of treatment efficacy and safety [55]. One of the essential characteristics of clinical trials is that results from limited sample of patients are used to make inferences about which treatment that should be recommended for the general population of patients in the future. In clinical practice, spine surgeons often make inferences about treatment from experiences of success in single cases. Since several factors such as biological variation and the treatment expectancy in patients with the same condition will show varied responses to the same treatment, groups of patients are required. Retrospective studies contain serious potential biases, such as observer and selection bias, that will influence results. The effectiveness of a new surgical treatment should be compared prospectively with a control group of similar patients receiving standard treatment. Although the great majority of clinical trials have been concerned with drug therapy within the pharmaceutical industry, over the last 25 years such trials have been accepted as the golden standard for evaluation of the effectiveness of spine surgery.


Table 3 presents two additional trials [17, 68]. One compared decompression and fusion with non-operative treatment and reported that although results favoured surgery, the effectiveness was not verified by intention-to-treat analysis [68]. Cross-overs and withdrawals were about 40%.

Accordingly, the three trials constitute moderate evidence that effectiveness of fusion is not better than intensive rehabilitation based on cognitive behavioural principles for improvement of disability, back pain, and return to work. This is in keeping with the conclusion of one recent systematic review [46] and one meta-analysis [26].

A systematic review included 11 trials on bone growth factors [48]. Two additional trials were included [14, 36]. The results were in agreement with the conclusion of the SR that the use of BMPs at the vertebrae can eliminate the need for surgery to harvest autologous bone, but that further RCTs of good methodological quality are adviseable so as to clarify the effectiveness of BMPs in clinical practice.

The best documented procedure in spine surgery is discectomy in selected patients with disc prolapse and sciatica. Therefore, it is a paradox that I usually do not recommend surgery for these patients, and these include spine surgeons, colleagues, and friends. They usually do not prefer surgery, and most of them recover completely without. Critics of evidence-based medicine would argue that my clinical practice illustrates that there is no place for evidence-based medicine. On the contrary, I am very confident that there is strong evidence to recommend discectomy for patients who cannot stand their leg pain.

One recent systematic review and one meta-analysis on fusion in patients with CLBP and disc degeneration concluded that this procedure is not more effective than modern rehabilitation based on cognitive behavioural principles [26, 46]. Meanwhile, spine surgeons have focused more on hypothesized adjacent level disc degeneration after fusion and the advantages of disc prostheses. Considering the most likely placebo effects of introducing a new device, the trials published comparing disc prosthesis with fusion are not convincing for the recommendation of disc prosthesis in carefully selected patients with CLBP.

The aim of this article was to describe the contribution of RCTs to quality management and their feasibility in practice, and not to conduct a systematic review. To give an overview, the conclusions of the latest Cochrane Reviews are presented along with results from an updated search. All published RCTs in this field have not been identified, by example the search was limited to Medline and trials published in English. In addition, two authors did not evaluate the identified trials independently. Despite possible selection and observer bias, the major results are in agreement with the latest Cochrane Reviews and later published systematic reviews [19, 20, 26, 46]. 041b061a72


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