IPD Coupled Decompression of Degenerative Spinal Stenosis: Comparative Results with Traditional Methods (original) (raw)
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Five-year durability of stand-alone interspinous process decompression for lumbar spinal stenosis
Clinical Interventions in Aging
Background: Lumbar spinal stenosis is the most common indication for spine surgery in older adults. Interspinous process decompression (IPD) using a stand-alone spacer that functions as an extension blocker offers a minimally invasive treatment option for intermittent neurogenic claudication associated with spinal stenosis. Methods: This study evaluated the 5-year clinical outcomes for IPD (Superion ®) from a randomized controlled US Food and Drug Administration (FDA) noninferiority trial. Outcomes included Zurich Claudication Questionnaire (ZCQ) symptom severity (ss), physical function (pf), and patient satisfaction (ps) subdomains, leg and back pain visual analog scale (VAS), and Oswestry Disability Index (ODI). Results: At 5 years, 84% of patients (74 of 88) demonstrated clinical success on at least two of three ZCQ domains. Individual ZCQ domain success rates were 75% (66 of 88), 81% (71 of 88), and 90% (79 of 88) for ZCQss, ZCQpf, and ZCQps, respectively. Leg and back pain success rates were 80% (68 of 85) and 65% (55 of 85), respectively, and the success rate for ODI was 65% (57 of 88). Percentage improvements over baseline were 42%, 39%, 75%, 66%, and 58% for ZCQss, ZCQpf, leg and back pain VAS, and ODI, respectively (all P,0.001). Within-group effect sizes were classified as very large for four of five clinical outcomes (ie, .1.0; all P,0.0001). Seventy-five percent of IPD patients were free from reoperation, revision, or supplemental fixation at their index level at 5 years. Conclusion: After 5 years of follow-up, IPD with a stand-alone spacer provides sustained clinical benefit.
BioMed Research International, 2014
Purpose.New interspinous process decompression devices (IPDs) provide an alternative to conservative treatment and decompressive surgery for patients with neurogenic intermittent claudication (NIC) due to degenerative lumbar spinal stenosis (DLSS). HeliFix is a minimally invasive IPD that can be implanted percutaneously. This is a preliminary evaluation of safety and effectiveness of this IPD up to 12 months after implantation.Methods.After percutaneous implantation in 100 patients with NIC due to DLSS, data on symptoms, quality of life, pain, and use of pain medication were obtained for up to 12 months.Results.Early symptoms and physical function improvements were maintained for up to 12 months. Leg, buttock/groin, and back pain were eased throughout, and the use and strength of related pain medication were reduced. Devices were removed from 2% of patients due to lack of effectiveness.Conclusions.Overall, in a period of up to 12-month follow-up, the safety and effectiveness of the ...
Asian Spine Journal, 2020
In this retrospective review study, the authors systematically reviewed the literature to elucidate the efficacy and complications associated with decompression and interspinous devices (ISDs) used in surgeries for lumbar spinal stenosis (LSS). LSS is a debilitating condition that affects the lumbar spinal cord and spinal nerve roots. However, a comprehensive report on the relative efficacy and complication rate of ISDs as they compare to traditional decompression procedures is currently lacking. The PubMed database was queried to identify clinical studies that exclusively investigated decompression, those that exclusively investigated ISDs, and those that compared decompression with ISDs. Only prospective cohort studies, case series, and randomized controlled trials that evaluated outcomes using the Visual Analog Scale (VAS), Oswestry Disability Index, or Japanese Orthopedic Association scores were included. A random-effects model was established to assess the difference between pr...
Interspinous Process Decompression: Expanding Treatment Options for Lumbar Spinal Stenosis
BioMed Research International, 2016
Interspinous process decompression is a minimally invasive implantation procedure employing a stand-alone interspinous spacer that functions as an extension blocker to prevent compression of neural elements without direct surgical removal of tissue adjacent to the nerves. The Superion® spacer is the only FDA approved stand-alone device available in the US. It is also the only spacer approved by the CMS to be implanted in an ambulatory surgery center. We computed the within-group effect sizes from the Superion IDE trial and compared them to results extrapolated from two randomized trials of decompressive laminectomy. For the ODI, effect sizes were allvery large(>1.0) for Superion and laminectomy at 2, 3, and 4 years. For ZCQ, the 2-year Superion symptom severity (1.26) and physical function (1.29) domains werevery large; laminectomy effect sizes werevery large(1.07) for symptom severity andlargefor physical function (0.80). Current projections indicate a marked increase in the num...
Clinical Neurology and Neurosurgery, 2014
Interspinous distraction devices provide an effective treatment for patients suffering from lumbar spinal stenosis and/or degenerative disk disease. The aim of this multicenter study was the prospective evaluation of patients treated for symptomatic lumbar spinal stenosis with interspinous process decompression (IPD) implants compared with a population of patients managed with conservative treatment. 542 patients affected by symptomatic lumbar spine degenerative disease were enrolled in a controlled trial. 422 patients underwent surgical treatment consisting of X-STOP device implantation, whereas 120 control cases were managed conservatively. Both patient groups underwent follow-up evaluations at 6, 12, 24, and 36 months using the Zurich Claudication Questionnaire, the Visual Analog Scale score and spinal lumbar X-rays, CT scans and MR imaging. One-year follow-up evaluation revealed positive good results in the 83.5% of patients treated with IPD with respect to 50% of the nonoperative group cases. During the first three years, in 38 out of the 120 control cases, a posterior decompression and/or spinal fixation was performed because of unsatisfactory results of the conservative therapy. In 24 of 422 patients, the IPD device had to be removed, and a decompression and/or pedicle screw fixation was performed because of the worsening of neurological symptoms. Our results support the effectiveness of surgery in patients with stenosis. IPD may offer an effective and less invasive alternative to classical microsurgical posterior decompression in selected patients with spinal stenosis and lumbar degenerative disk diseases.
Journal of spine surgery, 2020
Background Lumbar spinal stenosis is treated with decompression directly such as laminectomies and indirectly with an interspinous device through distraction and extension block. Interspinous devices (IPD) have also been used as an adjunct to spinal fusion. However, the design for IPD to treat spinal stenosis does not fixate the spine while the design for spinal fusion is designed to fixate the spine. There is a paucity of data on a single device that has been used for both fusion and stenosis. Authors aim to demonstrate the long-term outcomes of interspinous fixation at L4-5 for degenerative spinal stenosis. Methods We evaluated patients with spinal stenosis and degenerative disc disease who were treated with open decompression and distraction of the spinous processes at L4-L5 using an interspinous device. All patients complained of lower back pain and neurogenic claudication. This is a retrospective review of prospectively collected data (level 3) under an IRB approved study cohor...
Journal of Orthopaedic Surgery and Research, 2012
Background: Interspinous distraction devices (IPDD) are indicated as stand-alone devices for the treatment of spinal stenosis. The purpose of this study is to evaluate the results of patients undergoing surgery for spinal stenosis with a combination of unilateral microdecompression and interspinous distraction device insertion. Methods: This is a prospective clinical and radiological study of minimum 2 years follow-up. Twenty-two patients (average age 64.5 years) with low-back pain and unilateral sciatica underwent decompressive surgery for lumbar spinal stenosis. Visual Analogue Scale, Oswestry Disability Index and walking capacity plus radiologic measurements of posterior disc height of the involved level and lumbar lordosis Cobb angle were documented both preoperatively and postoperatively. One-sided posterior subarticular and foraminal decompression was conducted followed by dynamic stabilization of the diseased level with an IPDD (X-STOP).
Objective: To compare and analyze the safety and effectiveness of oblique lateral interbody fusion (OLIF) technique and conventional lumbar posterior laminar decompression for lumbar spinal stenosis (DLCS). Methods: From October 2019 to November 2021 68 patients with lumbar spinal stenosis over 60 years of age were divided into OLIF group and traditional decompression group according to their treatment methods. There were 32 patients (14 males and 18 females) in the OLIF group, with an age distribution of 60 years or older and a mean of (69.56 ± 4.18) years, and 36 patients (15 males and 21 females) in the traditional decompression group, with an age distribution of 60 years or older and a mean of (70.32 ± 4.82) years, treated with traditional posterior decompression internal fixation of the vertebral plate. The general data, operation time, intraoperative bleeding, hospital stay, surgical complications, clinical efficacy evaluated by modified MacNab criteria, and patients' preoperative and final postoperative pain visual analog scale scores (VAS) and Oswestry dysfunction index (ODI) were statistically analyzed in both groups. Results: There was no statistically significant difference in age, gender, BMI, disease duration, lesion segment, VAS score, and ODI index between the two groups before treatment (P>0.05). After treatment, the operation time, intraoperative bleeding, hospital stay, and surgical complications were more advantageous in the OLIF group compared with the conventional decompression group, with statistical significance between groups (P<0.05). Compared with the pre-treatment comparison, the VAS score and ODI score of patients in both groups showed significant improvement (P<0.05), and the comparison between the two groups could be found that the improvement in VSA and ODI scores at the end of postoperative period in the OLIF group was more significant than that in the traditional decompression group, with statistical difference (P<0.05). The clinical efficacy of the two groups evaluated by modified MacNab criteria at the end follow-up was 90.625% for the OLIF group and 80.55% for the conventional decompression group, respectively, with statistical differences (P < 0.05). Conclusion: Compared with traditional decompression fusion, the use of OLIF technique can safely and effectively decompress DLCS, and also has many advantages such as less trauma, less bleeding, shorter operative time and hospital stay, and lower postoperative complications, which is worthy of clinical preference.