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Interspinous process devices for treatment of degenerative lumbar spine stenosis: A systematic review and meta-analysis.

ABSTRACT: BACKGROUND:Degenerative lumbar spinal stenosis is a condition related to aging in which structural changes cause narrowing of the central canal and intervertebral foramen. It is currently the leading cause for spinal surgery in patients over 65 years. Interspinous process devices (IPDs) were introduced as a less invasive surgical alternative, but questions regarding safety, efficacy, and cost-effectiveness are still unanswered. OBJECTIVES:The aim of this study was to provide complete and reliable information regarding benefits and harms of IPDs when compared to conservative treatment or decompression surgery and suggest directions for forthcoming RCTs. METHODS:We searched MEDLINE, EMBASE, Cochrane Library, Scopus, and LILACS for randomized and quasi-randomized trials, without language or period restrictions, comparing IPDs to conservative treatment or decompressive surgery in adults with symptomatic degenerative lumbar spine stenosis. Data extraction and analysis were conducted following the Cochrane Handbook. Primary outcomes were pain assessment, functional impairment, Zurich Claudication Questionnaire, and reoperation rates. Secondary outcomes were quality of life, complications, and cost-effectiveness. This systematic review was registered at Prospero (International prospective register of systematic reviews) under number 42015023604. RESULTS:The search strategy resulted in 17 potentially eligible reports. At the end, nine reports were included and eight were excluded. Overall quality of evidence was low. One trial compared IPDs to conservative treatment: IPDs presented better pain, functional status, quality of life outcomes, and higher complication risk. Five trials compared IPDs to decompressive surgery: pain, functional status, and quality of life had similar outcomes. IPD implant presented a significantly higher risk of reoperation. We found low-quality evidence that IPDs resulted in similar outcomes when compared to standard decompression surgery. Primary and secondary outcomes were not measured in all studies and were often published in incomplete form. Subgroup analysis was not feasible. Difficulty in contacting authors may have prevented us of including data in quantitative analysis. CONCLUSIONS:Patients submitted to IPD implants had significantly higher rates of reoperation, with lower cost-effectiveness. Future trials should improve in design quality and data reporting, with longer follow-up periods.

SUBMITTER: Poetscher AW

PROVIDER: S-EPMC6034833 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Interspinous process devices for treatment of degenerative lumbar spine stenosis: A systematic review and meta-analysis.

Poetscher Arthur Werner AW Gentil Andre Felix AF Ferretti Mario M Lenza Mario M

PloS one 20180706 7

<h4>Background</h4>Degenerative lumbar spinal stenosis is a condition related to aging in which structural changes cause narrowing of the central canal and intervertebral foramen. It is currently the leading cause for spinal surgery in patients over 65 years. Interspinous process devices (IPDs) were introduced as a less invasive surgical alternative, but questions regarding safety, efficacy, and cost-effectiveness are still unanswered.<h4>Objectives</h4>The aim of this study was to provide compl ...[more]

PMID: 29979691

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Project description:Retrospective subgroup analysis of prospectively collected data according to treatment received.The purpose of this study was to determine whether obesity affects treatment outcomes for lumbar stenosis (SpS) and degenerative spondylolisthesis (DS).Obesity is thought to be associated with increased complications and potentially less favorable outcomes after the treatment of degenerative conditions of the lumbar spine. This, however, remains a matter of debate in the existing literature.An as-treated analysis was performed on patients enrolled in the Spine Patient Outcomes Research Trial for the treatment of SpS or DS. A comparison was made between patients with a body mass index (BMI) of less than 30 ("nonobese," n = 373 SpS and 376 DS) and those with a BMI of 30 or more ("obese," n = 261 SpS and 225 DS). Baseline patient characteristics, intraoperative data, and complications were documented. Primary and secondary outcomes were measured at baseline and regular follow-up time intervals up to 4 years. The difference in improvement over baseline between surgical and nonsurgical treatment (i.e., treatment effect) was determined at each follow-up interval for the obese and nonobese groups.At 4-year follow-up, operative and nonoperative treatment provided improvement in all primary outcome measures over baseline in patients with BMI of less than 30 and 30 or more. For patients with SpS, there were no differences in the surgical complication or reoperation rates between groups. Patients with DS with BMI of 30 or more had a higher postoperative infection rate (5% vs. 1%, P = 0.05) and twice the reoperation rate at 4-year follow-up (20% vs. 11%, P = 0.01) than those with BMI of less than 30. At 4 years, surgical treatment of SpS and DS was equally effective in both BMI groups in terms of the primary outcome measures, with the exception that obese patients with DS had less improvement from baseline in the 36-Item Short Form Health Survey (SF-36) physical function score than nonobese patients (22.6 vs. 27.9, P = 0.022). With nonoperative treatment, patients with SpS with BMI of 30 or more did worse in regard to all 3 primary outcome measures, and patients with DS with BMI of 30 or more had similar SF-36 bodily pain scores but less improvement over baseline in the SF-36 physical function and Oswestry Disability Index scores. Treatment effects for SpS and DS were significant within each BMI group for all primary outcome measures in favor of surgery. Obese patients had a significantly greater treatment effect than nonobese patients with SpS (Oswestry Disability Index, P = 0.037) and DS (SF-36 PF, P = 0.004) largely due to the relatively poor outcome of nonoperative treatment in obese patients.Obesity does not affect the clinical outcome of operative treatment of SpS. There are higher rates of infection and reoperation and less improvement from baseline in the SF-36 physical function score in obese patients after surgery for DS. Nonoperative treatment may not be as effective in obese patients with SpS or DS.

Project description:BackgroundLumbar spinal stenosis (LSS) is caused by neural compression due to narrowing of the lumbar spinal canal or neural foramen. Surgical intervention is a standard treatment for LSS; however, the steep increase in the surgical rate, post-operative complications, and comparatively low long-term satisfaction are considered to be limitations of this surgical approach. Conversely, acupotomy is a minimally invasive technique that combines the effects of conventional acupuncture with micro-incision, which may offer an alternative to surgery for the treatment of LSS. This review was conducted to investigate and critically review the current evidence on the efficacy and safety of acupotomy for LSS.MethodsEleven databases were searched from their respective inception dates to December 28, 2018. Randomized controlled trials (RCTs) comparing acupotomy and wait-list, sham treatment, or active controls were included. The quality of the included studies was assessed using risk-of-bias tool.ResultsSeven RCTs were included in this review and meta-analysis. The methodological quality of the included studies was generally poor. The acupotomy treatment group was associated with significantly lower visual analogue scale scores (range 0∼10) (5 RCTs; mean difference [MD] -1.55, 95% confidence interval [CIs] -2.60 to -0.50; I = 94%) and higher Japanese Orthopedic Association Score (3 RCTs; MD 4.70, 95% CI 3.73 to 5.68; I = 0%) compared to the active control group. In subgroup analysis based on the type of active controls, acupotomy retained significant benefits over lumbar traction and acupuncture, as well as over lumbar traction, spinal decompression, and acupuncture. Safety data were reported in only 1 study, and no adverse events occurred in either the acupotomy or the acupuncture control group.ConclusionAccording to current evidence, acupotomy might be beneficial for treating LSS. Acupotomy showed consistent superiority over lumbar traction, but the results were mixed in comparisons with other interventions, such as spinal decompression and acupuncture. However, the findings should be interpreted cautiously, given the poor methodological quality of the included studies, and potential small-study effects. Further larger, high-quality, rigorous RCTs should be conducted on this topic and rigorous reporting of acupotomy procedures and safety data should be encouraged.

Dataset Information

Interspinous process devices for treatment of degenerative lumbar spine stenosis: A systematic review and meta-analysis.

Publications

Interspinous process devices for treatment of degenerative lumbar spine stenosis: A systematic review and meta-analysis.

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