Interspinous process devices(IPD) alone versus decompression surgery for lumbar spinal stenosis(LSS): A systematic review and meta-analysis of randomized controlled trials

Zhao, Xingwen; Ma, Jianxiong; Ma, Xinlong; Li, Fēi; He, Weiwei; Xuan, Jianhua; Wang, Yin; Han, Baohui; Lü, Bin

doi:10.1016/j.ijsu.2017.01.074

Cited by 28 publications

(32 citation statements)

References 35 publications

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“…The overall reoperation rate was higher in the IPD group in all studies, with the trial from Azzazzi et al[ 10 ] being the only exception, reporting a risk ratio of 0.50 [0.05, 5.22]. Among the other studies, risk ratios ranged from 1.53 [0.71, 3.27] [ 4 ] to 3.08 [1.48, 6.43] [ 19 ]. Lonne et al[ 12 , 13 ] interrupted recruiting after midterm evaluation due to high rates of reoperation secondary to persistent or recurrent symptoms in the IPD group.…”

Section: Resultsmentioning

confidence: 99%

“…Azzazzi et al[ 10 ], Moojen et al[ 14 ] and Stromkvist et al[ 15 ] considered only direct surgical complications, whereas Davis et al[ 11 ] used more ample criteria. Risk ratio ranged from 0.17 [0.04, 0.68] [ 2 ] to 1.34 [0.37, 4.79] [ 19 ]. Meta-analysis resulted in a risk ratio of 0.66 [0.24, 1.83], with high heterogeneity (I 2 = 68%).…”

Section: Resultsmentioning

confidence: 99%

“…Zhao et al[ 19 ] considered only RCTs and included 4 trials. Their analysis indicated that IPDs had higher reoperation rates, higher back pain scores and worse cost-effectiveness compared with decompression.…”

Section: Discussionmentioning

confidence: 99%

“…Randomized controlled trials (RCT) have compared IPDs to conservative treatment [ 7 – 9 ] or to standard surgery[ 10 – 16 ], but there is an overall concern regarding bias risks and small population samples. Four systematic reviews have been published[ 17 – 20 ], but only one of these reviews examined exclusively RCTs[ 19 ]. Nevertheless, this systematic review included only 4 of the available studies.…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2018

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BackgroundDegenerative 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.ObjectivesThe 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.MethodsWe 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.ResultsThe 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.ConclusionsPatients 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.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2018

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“…Despite these merits, interspinous or interlaminar stabilization devices can induce some novel complications that are unique to this surgical procedure, such as spinous process fracture, device breakage, and dislodgment [ 8 , 9 , 16 ]. Regarding the Coflex device, the incidence of device-related complications has been reported in up to 24.4% of these patients [ 17 ].…”

Section: Introductionmentioning

confidence: 99%

Interlaminar stabilization offers greater biomechanical advantage compared to interspinous stabilization after lumbar decompression: a finite element analysis

Teng

2020

J Orthop Surg Res

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Background Interlaminar stabilization and interspinous stabilization are two newer minimally invasive methods for lumbar spine stabilization, used frequently in conjunction with lumbar decompression to treat lumbar stenosis. The two methods share certain similarities, therefore, frequently being categorized together. However, the two methods offer distinct biomechanical properties, which affect their respective effectiveness and surgical success. Objective To compare the biomechanical characteristics of interlaminar stabilization after lumbar decompression (ILS) and interspinous stabilization after lumbar decompression (ISS). For comparison, lumbar decompression alone (DA) and decompression with instrumented fusion (DF) were also included in the biomechanical analysis. Methods Four finite element models were constructed, i.e., DA, DF, ISS, and ILS. To minimize device influence and focus on the biomechanical properties of different methods, Coflex device as a model system was placed at different position for the comparison of ISS and ILS. The range of motion (ROM) and disc stress peak at the surgical and adjacent levels were compared among the four surgical constructs. The stress peak of the spinous process, whole device, and device wing was compared between ISS and ILS. Results Compared with DA, the ROM and disc stress at the surgical level in ILS or ISS were much lower in extension. The ROM and disc stress at the surgical level in ILS were 1.27° and 0.36 MPa, respectively, and in ISS 1.51°and 0.55 MPa, respectively in extension. This is compared with 4.71° and 1.44 MPa, respectively in DA. ILS (2.06–4.85° and 0.37–0.98 MPa, respectively) or ISS (2.07–4.78° and 0.37–0.98 MPa, respectively) also induced much lower ROM and disc stress at the adjacent levels compared with DF (2.50–7.20° and 0.37–1.20 MPa, respectively). ILS further reduced the ROM and disc stress at the surgical level by 8% and 25%, respectively, compared to ISS. The stress peak of the spinous process in ILS was significantly lower than that in ISS (13.93–101 MPa vs. 31.08–172.5 MPa). In rotation, ILS yielded a much lower stress peak in the instrumentation wing than ISS (128.7 MPa vs. 222.1 MPa). Conclusion ILS and ISS partly address the issues of segmental instability in DA and hypermobility and overload at the adjacent levels in DF. ILS achieves greater segmental stability and results in a lower disc stress, compared to ISS. In addition, ILS reduces the risk of spinous process fracture and device failure.

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Minimally Invasive Spine Surgery Complications with Implant Placement and Fixation

Butler

Kurd

2019

Minimally Invasive Spine Surgery

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Interspinous process devices(IPD) alone versus decompression surgery for lumbar spinal stenosis(LSS): A systematic review and meta-analysis of randomized controlled trials

Cited by 28 publications

References 35 publications

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

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

Interlaminar stabilization offers greater biomechanical advantage compared to interspinous stabilization after lumbar decompression: a finite element analysis

Minimally Invasive Spine Surgery Complications with Implant Placement and Fixation

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