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Minimally invasive treatment of moderate lumbar spinal stenosis with the superion interspinous spacer.

ABSTRACT: We evaluated the safety and effectiveness of the minimally invasive Superion(®) Interspinous Spacer (VertiFlex, Inc., San Clemente, CA) in patients with moderate LSS.This single-arm prospective study enrolled 121 patients with moderate LSS between February 2008 and August 2009 and were followed up at 1 (n=111), 3 (n=96), 6 (n=81), and 12 (n=52) months. All patients were treated with the Superion Interspinous Spacer. Main outcomes were back function with the Oswestry Disability Index (ODI), extremity and axial pain severity with an 11-point scale, health-related quality of life with the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36, and adverse events through 12 months.ODI improved 64% (p<0.001) through 12 months and clinical success was 92%. Extremity and axial pain improved 53% and 49% (both p<0.001), respectively, through 12 months with clinical success of 76% for axial pain and 86% for extremity pain. Health-related quality of life improved 41% for PCS and 22% for MCS (both p<0.001) through 12 months. PCS clinical success was 81% and MCS clinical success was 62% at 12 months. Four (5.9%) explants were performed although 3 were unrelated to the device. Eight procedure-related adverse events, observed in 6 (5.0%) patients, included superficial incision seroma (n=5), minor wound pain (n=2), and infection (n=1).Preliminary results with the Superion Interspinous Spacer suggest that it is an effective and safe treatment option for patients with moderate LSS who are unresponsive to conservative care.

SUBMITTER: Bini W

PROVIDER: S-EPMC3201565 | biostudies-other | 2011

REPOSITORIES: biostudies-other

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Minimally invasive treatment of moderate lumbar spinal stenosis with the superion interspinous spacer.

Bini Walter W Miller Larry E LE Block Jon E JE

The open orthopaedics journal 20111014

<h4>Purpose</h4>We evaluated the safety and effectiveness of the minimally invasive Superion(®) Interspinous Spacer (VertiFlex, Inc., San Clemente, CA) in patients with moderate LSS.<h4>Methods</h4>This single-arm prospective study enrolled 121 patients with moderate LSS between February 2008 and August 2009 and were followed up at 1 (n=111), 3 (n=96), 6 (n=81), and 12 (n=52) months. All patients were treated with the Superion Interspinous Spacer. Main outcomes were back function with the Oswest ...[more]

PMID: 22043255

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Project description:Background and objectivesThis study evaluated the long-term durability of the minimally invasive lumbar decompression (MILD) procedure in terms of functional improvement and pain reduction for patients with lumbar spinal stenosis and neurogenic claudication due to hypertrophic ligamentum flavum. This is a report of 2-year follow-up for MILD study patients.MethodsThis prospective, multicenter, randomized controlled clinical study compared outcomes for 143 patients treated with MILD versus 131 treated with epidural steroid injections. Follow-up occurred at 6 months and at 1 year for the randomized phase and at 2 years for MILD subjects only. Oswestry Disability Index, Numeric Pain Rating Scale, and Zurich Claudication Questionnaire were used to evaluate function and pain. Safety was evaluated by assessing incidence of device-/procedure-related adverse events.ResultsAll outcome measures demonstrated clinically meaningful and statistically significant improvement from baseline through 6-month, 1-year, and 2-year follow-ups. At 2 years, Oswestry Disability Index improved by 22.7 points, Numeric Pain Rating Scale improved by 3.6 points, and Zurich Claudication Questionnaire symptom severity and physical function domains improved by 1.0 and 0.8 points, respectively. There were no serious device-/procedure-related adverse events, and 1.3% experienced a device-/procedure-related adverse event.ConclusionsMILD showed excellent long-term durability, and there was no evidence of spinal instability through 2-year follow-up. Reoperation and spinal fracture rates are lower, and safety is higher for MILD versus other lumbar spine interventions, including interspinous spacers, surgical decompression, and spinal fusion. Given the minimally invasive nature of this procedure, its robust success rate, and durability of outcomes, MILD is an excellent choice for first-line therapy for select patients with central spinal stenosis suffering from neurogenic claudication symptoms with hypertrophic ligamentum flavum.Clinical trial registrationThis study was registered at ClinicalTrials.gov, identifier NCT02093520.

Project description:This study aimed to compare the efficacy of muscle gap approach under a minimally invasive channel surgical technique with the traditional median approach.In the Orthopedics Department of Traditional Chinese and Western Medicine Hospital, Tongzhou District, Beijing, 68 cases of lumbar spinal canal stenosis underwent surgery using the muscle gap approach under a minimally invasive channel technique and a median approach between September 2013 and February 2016. Both approaches adopted lumbar spinal canal decompression, intervertebral disk removal, cage implantation, and pedicle screw fixation. The operation time, bleeding volume, postoperative drainage volume, and preoperative and postoperative visual analog scale (VAS) score and Japanese Orthopedics Association score (JOA) were compared between the 2 groups.All patients were followed up for more than 1 year. No significant difference between the 2 groups was found with respect to age, gender, surgical segments. No diversity was noted in the operation time, intraoperative bleeding volume, preoperative and 1 month after the operation VAS score, preoperative and 1 month after the operation JOA score, and 6 months after the operation JOA score between 2 groups (P > .05). The amount of postoperative wound drainage (260.90 ± 160 mL vs 447.80 ± 183.60 mL, P < .001) and the VAS score 6 months after the operation (1.71 ± 0.64 vs 2.19 ± 0.87, P = .01) were significantly lower in the muscle gap approach group than in the median approach group (P < .05). In the muscle gap approach under a minimally invasive channel group, the average drainage volume was reduced by 187 mL, and the average VAS score 6 months after the operation was reduced by an average of 0.48.The muscle gap approach under a minimally invasive channel technique is a feasible method to treat long segmental lumbar spinal canal stenosis. It retains the integrity of the posterior spine complex to the greatest extent, so as to reduce the adjacent spinal segmental degeneration and soft tissue trauma. Satisfactory short-term and long-term clinical results were obtained.

Project description:Purpose:To develop a self-administered diagnostic screening questionnaire for lumbar spinal stenosis (LSS) consisting of items with high content validity and to investigate the diagnostic value of the questionnaire and the items. Patients and Methods:A self-reported diagnostic LSS screening questionnaire was developed based on items from the existing literature describing key symptoms of LSS. The screening questionnaire (index test) was to be tested in a cohort of patients with persistent lumbar and/or leg pain recruited from a Danish publicly funded outpatient secondary care spine clinic with clinicians performing the reference test. However, to avoid unnecessary collection of data if the screening questionnaire proved to be of limited value, a case-control design was incorporated into the cohort design including an interim analysis. Additional cases for the case-control study were recruited at two Danish publicly funded spine surgery departments. Prevalence, sensitivity, specificity and diagnostic odds ratio (OR) were calculated for each individual item, and AUC (area under the curve) was calculated to examine the performance of the full questionnaire. Results:A 13-item Danish questionnaire was developed and tested in 153 cases and 230 controls. The interim analysis was not in favour of continuing the cohort study, and therefore, only results from the case-control study are reported. There was a positive association for all items except the presence of back pain. However, the association was only moderate with ORs up to 3.3. When testing the performance of the whole questionnaire, an AUC of 0.72 was reached with a specificity of 20% for a fixed sensitivity of 95%. Conclusion:The items were associated with LSS and therefore have some potential to identify LSS patients. However, the association was not strong enough to provide sufficient accuracy for a diagnostic tool. Additional dimensions of symptoms of LSS need identification to obtain a reliable questionnaire for screening purposes.

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Minimally invasive treatment of moderate lumbar spinal stenosis with the superion interspinous spacer.

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Minimally invasive treatment of moderate lumbar spinal stenosis with the superion interspinous spacer.

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