Surgical or Nonoperative Treatment for Lumbar Spinal Stenosis?
ABSTRACT 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.
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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. Purpose 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. Study Design/Setting This cross-sectional study analyzed publicly available internet information, including videos on the website YouTube regarding the X-Stop device. Patient Sample No patients were involved in this study. Outcome Measures No specific outcome measures were used. Methods 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. Results 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. Conclusions 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 · 2.80 Impact Factor
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ABSTRACT: While total hip arthroplasty (THA) and total knee arthroplasty (TKA) have been widely accepted as highly cost-effective procedures, spine surgery for the treatment of degenerative conditions does not share the same perception among stakeholders. In particular, the sustainability of the outcome and cost-effectiveness following LSS surgery compared to THA/TKA remain uncertain. To estimate the lifetime incremental cost-utility ratios for decompression and decompression with fusion for focal LSS versus THA and TKA for osteoarthritis (OA) from the perspective of the provincial health insurance system (predominantly from the hospital perspective) based on long-term health status data at a median of 5 years post-surgical intervention. An incremental cost-utility analysis from a hospital perspective was based on a single-center, retrospective longitudinal matched cohort study of prospectively collected outcomes and retrospectively collected costs. Patients who had undergone primary one- to two-level spinal decompression with or without fusion for focal LSS (FLSS) were compared with a matched cohort of patients who had undergone elective THA or TKA for primary OA. Incremental cost-utility ratio ($/QALY) determined using perioperative costs (direct and indirect) and Short Form-6D (SF-6D) utility scores converted from the SF-36. Patient outcomes were collected using the SF-36 survey preoperatively and annually for a minimum of 5 years. Utility was modeled over the lifetime and quality-adjusted-life-years (QALY) were determined using the median 5-year health status data. The primary outcome measure, cost per QALY gained, was calculated by estimating the mean incremental lifetime costs and QALYs for each diagnosis group after discounting costs and QALYs at 3%. Sensitivity analyses adjusting for, + 25% primary and revision surgery cost, + 25% revision rate, upper and lower confidence interval utility score, variable inpatient rehabilition rate for THA/TKA and discounting at 5%, were conducted to determine factors affecting the value of each type of surgery. At a median of 5 years (4-7 years), follow-up and revision surgery data was attained for 85%-FLSS, 80%-THA and 75%-THA of the cohorts. The 5-year ICURs were $21,702/QALY for THA; $28,595/QALY for TKA; $12,271/QALY for spinal decompression; and $35,897/QALY for spinal decompression with fusion. The estimated lifetime ICURs using the median 5-year follow-up data was $5,682/QALY for THA; $6,489/QALY for TKA; $2,994/QALY for spinal decompression; and $10,806/QALY for spinal decompression with fusion. The overall spine (decompression alone and decompression and fusion) ICUR was $5,617/QALY. The estimated best and worst-case lifetime ICURs varied from $1,126/QALY for the best-case (spinal decompression) to $39,323/QALY for the worst case (spinal decompression with fusion). Surgical management of primary OA of the spine, hip and knee results in durable costutility ratios that are well below accepted thresholds for cost-effectiveness. Despite a significantly higher revision rate, the overall surgical management of FLSS for those who have failed medical management results in similar median 5-year and lifetime cost-utility compared to those of THA and TKA for the treatment of OA from the limited perspective of a public health insurance system.The spine journal: official journal of the North American Spine Society 11/2013; 13(9). DOI:10.1016/j.spinee.2013.11.011 · 2.80 Impact Factor
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ABSTRACT: The fear-avoidance model offers a promising framework for understanding the development of chronic postoperative pain and disability. However, limited research has examined this model in patients undergoing spinal surgery. To determine whether preoperative and early postoperative fear of movement predicts pain, disability, and physical health at 6 months following spinal surgery for degenerative conditions, after controlling for depressive symptoms and other potential confounding variables. A prospective cohort study conducted at an academic outpatient clinic. One hundred forty-one patients undergoing surgery for lumbar or cervical degenerative conditions. Self-reported pain and disability were measured with the Brief Pain Inventory and the Oswestry Disability Index/Neck Disability Index, respectively. The physical composite scale of the 12-Item Short-Form Health Survey (SF-12) measured physical health. Data collection occurred preoperatively and at 6 weeks and 6 months following surgery. Fear of movement was measured with the Tampa Scale for Kinesiophobia and depression with the Prime-MD PHQ-9. One hundred and twenty patients (85% follow-up) completed the 6-month postoperative assessment. Multivariable mixed-method linear regression analyses found that early postoperative fear of movement (6 weeks) predicted pain intensity, pain interference, disability, and physical health at 6-month follow-up (p<.05). Preoperative and early postoperative depression predicted pain interference, disability, and physical health. Results provide support for the fear-avoidance model in a postsurgical spine population. Early postoperative screening for fear of movement and depressive symptoms that do not acutely improve following surgical intervention appears warranted. Cognitive and behavioral strategies may be beneficial for postsurgical patients with high fear of movement and/or depressive symptoms.The spine journal: official journal of the North American Spine Society 11/2013; DOI:10.1016/j.spinee.2013.06.087 · 2.80 Impact Factor