A randomized controlled trial.
To assess the effectiveness of decompressive surgery as compared with nonoperative measures in the treatment of patients with lumbar spinal stenosis.
No previous randomized trial has assessed the effectiveness of surgery in comparison with conservative treatment for spinal stenosis.
Four university hospitals agreed on the classification of the disease, inclusion and exclusion criteria, radiographic routines, surgical principles, nonoperative treatment options, and follow-up protocols. A total of 94 patients were randomized into a surgical or nonoperative treatment group: 50 and 44 patients, respectively. Surgery comprised undercutting laminectomy of the stenotic segments in 10 patients augmented with transpedicular fusion. The primary outcome was based on assessment of functional disability using the Oswestry Disability Index (scale, 0-100). Data on the intensity of leg and back pain (scales, 0-10), as well as self-reported and measured walking ability were compiled at randomization and at follow-up examinations at 6, 12, and 24 months.
Both treatment groups showed improvement during follow-up. At 1 year, the mean difference in favor of surgery was 11.3 in disability (95% confidence interval [CI], 4.3-18.4), 1.7 in leg pain (95% CI, 0.4-3.0), and 2.3(95% CI, 1.1-3.6) in back pain. At the 2-year follow-up, the mean differences were slightly less: 7.8 in disability (95% CI, 0.8-14.9) 1.5 in leg pain (95% CI, 0.3-2.8), and 2.1 in back pain (95% CI, 1.0-3.3). Walking ability, either reported or measured, did not differ between the two treatment groups.
Although patients improved over the 2-year follow-up regardless of initial treatment, those undergoing decompressive surgery reported greater improvement regarding leg pain, back pain, and overall disability. The relative benefit of initial surgical treatment diminished over time, but outcomes of surgery remained favorable at 2 years. Longer follow-up is needed to determine if these differences persist.
"Also, it was noted if the web site indicated that conservative treatments exist but did not discuss any specifics. Based on the surgical techniques seen in the literature for treating LSS, we analyzed each web site for the inclusion of the following surgical alternatives to X-Stop: laminectomy, laminectomy with fusion, laminotomy, foraminotomy, and facetectomy   . Also, it was noted if the web sites indicated the existence of surgical alternatives but did not go into specifics. "
[Show abstract][Hide abstract] ABSTRACT: Background Context
The internet is frequently used by patients to aid in medical decision-making. Multiple studies display the internet’s ineffectiveness in presenting high quality information regarding surgical procedures and devices. With recent reports of unacceptably high complication rates and poor outcomes with the X-Stop device, it is important that online information is comprehensive and accurate. This study is the first to examine internet information on the controversial X-Stop.
We wished to determine how accurately public information over the internet portrays what exists in primary literature on the X-Stop, how extensively the X-Stop is characterized online, and how patient decision-making could foreseeably be affected.
This cross-sectional study analyzed publicly available internet information, including videos on the website YouTube regarding the X-Stop device.
No patients were involved in this study.
No specific outcome measures were used.
Search engines Google, Yahoo, and Bing were used to identify 105 websites providing information on X-Stop. Videos on the website YouTube were included. Websites were categorized based on authorship. Each site was analyzed for the provision of appropriate patient inclusion and exclusion criteria, surgical and non-surgical treatment alternatives, purported benefits, common complications, peer-reviewed literature citations, and descriptions/diagrams of the procedure. Data were evaluated for each authorship subgroup and for the entire group of sites. We did not receive any funding, nor were there conflicts of interest.
43% of sites were authored by a private medical group, 4% by an academic medical group, 16% by an insurance company, 9% by biomedical industry, 10% by news sources, and 19% by other. 31% of websites and 11% of sites authored by private medical groups contained references to peer-reviewed literature. 56% of websites reported patient inclusion criteria, while 33% reported exclusion criteria. Benefits and complications were reported within 91% and 23% of sites, respectively. Surgical and non-surgical treatment options were mentioned within 59% and 61% of websites.
Our study demonstrates the internet’s ineffectiveness in reporting quality information on the X-Stop. Information was often incomplete and potentially misleading. Significant controversy exists within primary literature regarding the safety and efficacy of the X-Stop. Yet, publicly available internet information largely provided misinformation and did not reflect any such controversy. This raises the concern that such information lends itself more towards patient recruitment than patient education. Medical professionals need to know how this may affect their patients’ decision-making.
The spine journal: official journal of the North American Spine Society 11/2014; 14(10). DOI:10.1016/j.spinee.2014.01.056 · 2.43 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Retrospective study.
The main purpose of this study was to investigate the union-rate of the spinous process after performing a spinous process osteotomy and whether union affects the clinical results after surgery.
In the present study, spinous process osteotomy was used to facilitate access to the spinal canal when performing a decompressive procedure for lumbar spinal stenosis. The aim of this study was to evaluate the union rate of the spinous process and its effect on the clinical results of the procedure.
All patients were included in the study that underwent a decompressive procedure through spinous process osteotomy be between January 1, 2007 and December 31, 2007. Operation protocols were reviewed. A computed tomography (CT) scan was performed to evaluate the union of the osteotomies of the spinous process. According to the CT-scans, patients were divided into three groups: "complete-union," "partial-union," and "non-union." Patients reported their clinical results through a self-administered questionnaire.
The mean period of follow up was 21.6 months (range, 16-28 months). A total of 44% of the performed osteotomies were considered as united. Ten patients (18%) were classified as "complete-union," 30 patients (55%) as "partial-union," and 15 patients (27%) as "non-union." The "complete-union" group showed better clinical results and scored significantly better in the Oswestry Disability Index and EQ-5D. However, no statistical difference was found in the pain-scores. There were no differences between the "partial-union" group and the "no-union" group.
We found a radiologic union for 60 out of 135 (44%) spinous process osteotomies.
Asian spine journal 04/2014; 8(2):138-44. DOI:10.4184/asj.2014.8.2.138
"Spinal decompression relieves the local stenotic pathology and has been shown to improve the symptoms of back and leg pain after surgery [6,7]. There are several studies showing superior results after surgery compared to conservative treatment [7,8,9,10,11] for symptomatic LSS. In the absence of progressive neurological deficit or cauda equina syndrome, surgical options are considered electively when conservative measures fail to relieve the patient's symptoms . "
[Show abstract][Hide abstract] ABSTRACT: Prospective cohort study.
To assess whether additional implantation of Coflex following spinal decompression provided better clinical outcomes compared to decompression alone for symptomatic lumbar spinal stenosis (LSS) and to determine whether improvement in clinical outcomes correlated with changes in the radiological indices studied.
Literature on benefits of additional Coflex implantation compared to decompression alone for symptomatic LSS is limited.
Patients with symptomatic LSS who met the study criteria were offered spinal decompression with Coflex implantation. Those patients who accepted Coflex implantation were placed in the Coflex group (n=22); while those opting for decompression alone, were placed in the comparison group (n=24). Clinical outcomes were assessed preoperatively, six-months, one-year and two-years postoperatively, using the Oswestry disability index, 100 mm visual analogue scale (VAS)-back pain and VAS-leg pain, and short form-36 (SF-36). Radiological indices (disc height, foraminal height and sagittal angle) were assessed preoperatively, six months, one year, and two years postoperatively.
Both groups showed statistically significant (p<0.001) improvement in all the clinical outcome indicators at all points in time as compared to the preoperative status. However, improvement in the Coflex group was significantly greater (p<0.001) than the comparison group. Changes in the radiological indices did not correlate significantly with the improvement in clinical outcome indicators.
Additional Coflex implantation after spinal decompression in symptomatic LSS offers better clinical outcomes than decompression alone in the short-term. Changes in radiological indices do not correlate with the improvements in clinical outcomes after surgery for symptomatic LSS.
Asian spine journal 04/2014; 8(2):161-9. DOI:10.4184/asj.2014.8.2.161
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