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Journal Journal of Neurological Sciences (Turkish)
Year
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OBJECTIVE:The purpose of this study is to determine the efficacy and safety of unilateral laminotomy for decompression of lumbar stenosis (LS). Although minimally invasive procedures are gaining increasing popularity in the treatment of spinal disorders, minimally invasive techniques are not standard in the surgical treatment of lumbar stenosis yet.METHODS:Fifty-two consecutive patients with lumbar stenosis were randomized to two treatment groups (unilateral laminotomy for decompression-Group 1, decompressive laminectomy-Group 2). Maximum walking distance (MWD), Oswestry Disability Index (ODI), spinal MRI and CT, and flexion-extension radiography were used to assess clinical outcome, adequacy of decompression and postoperative instability.RESULTS:Excellent-good clinical outcome was obtained in 88% of patients in Group 1 and in 69% of patients in Group 2. Increase in MWD and dural sac area after surgery were adequate in both groups. Postoperative spinal instability occurred in five patients in Group 2, none in Group 1. There was no surgical complication in the groups.CONCLUSIONS:Unilateral laminotomy for decompression is an effective and safe technique for treatment of LS. This technique ensures adequate decompression and good clinical outcome. It does not cause spinal instability.

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Journal Spine
Year 2013
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Study Design. Prospective, randomized controlled studyObjective. To compare the functional outcomes and extent of paraspinal muscle damage between two decompressive techniques for lumbar canal stenosis (LCS).Summary of Background Data. Lumbar spinous process splitting decompression (LSPSD) preserves the muscular and ligamentous attachments of the posterior elements of the spine. It can potentially avoid problems like paraspinal muscle atrophy and trunk extensor weakness that can occur following conventional midline decompression (CMD). However large series prospective randomized controlled studies are lacking.Methods. Patients with LCS were randomly allocated into two groups: LSPSD (28 patients) and CMD (23 patients). The differences in operative time, blood loss, time to comfortable mobilization and hospital stay were studied. Paraspinal muscle damage was assessed by post operative rise in CPK and CRP levels. Functional outcome was evaluated at one year by JOA score, NCOS, VAS for Back pain and Neurogenic Claudication.Results. 51 patients of mean age 56 years were followed up for a mean 14.2 ± 2.9 months. There were no significant differences in the operative time, blood loss, and hospital stay. Both the groups showed significant improvement in the functional outcome scores at one year. Between the two groups, the JOA score, NCOS improvement, BPVAS, NCVAS and the post-operative changes in serum CRP and CPK levels did not show any statistically significant difference. Based on JOA recovery rate, 73.9% of CMD group had good outcomes compared to only 60.7% after LSPSD.Conclusion. The functional outcome scores, back pain and claudication pain in the immediate period and at the end of one year are similar in both the techniques. More patients had better functional outcomes after conventional decompression than the LSPSD technique. Based on the present study, the superiority of one technique over the other is not established mandating the need for further long term studies.

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STUDY DESIGN: Survey based on complication scenarios. OBJECTIVE: To assess and compare perceived potential impacts of various perioperative adverse events by both surgeons and patients. SUMMARY OF BACKGROUND DATA: Incidence of adverse events after adult spinal deformity surgery remains substantial. Patient-centered outcomes tools measuring the impact of these events have not been developed. An important first step is to assess the perceptions of surgeons and patients regarding the impact of these events on surgical outcome and quality of life. METHODS: Descriptions of 22 potential adverse events of surgery (heart attack, stroke, spinal cord injury, nerve root injury, cauda equina injury, blindness, dural tear, blood transfusion, deep vein thrombosis, pulmonary embolism, superficial infection, deep infection, lung failure, urinary tract infection, nonunion, adjacent segment disease, persistent deformity, implant failure, death, renal failure, gastrointestinal complications, and sexual dysfunction) were presented to 14 spinal surgeons and 16 adult patients with spinal deformity. Impact scores were assigned to each complication on the basis of perceptions of overall severity, satisfaction with surgery, and effect on quality of life. Impact scores were compared between surgeons and patients with a Wilcoxon/Kruskal-Wallis test. RESULTS: Mean impact scores varied from 0.9 (blood transfusion) to 10.0 (death) among surgeons and 2.3 (urinary tract infection) to 9.2 (stroke) among patients. Patients' scores were consistently higher (P < 0.05) than surgeons in all 3 categories for 6 potential adverse events: stroke, lung failure, heart attack, pulmonary embolism, dural tear, and blood transfusion. Three additional complications (renal failure, non-union, and deep vein thrombosis) were rated higher in 1 or 2 categories by patients. CONCLUSION: There was substantial variation in how both surgeons and patients perceived impacts of various adverse events after spine surgery. Patients generally perceived the impact of adverse events to be greater than surgeons. Patient-centered descriptions of adverse events would provide a more complete description of surgical outcomes.

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Journal Journal of neurosurgery. Spine
Year 2011
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Object. To reduce intraoperative damage to the posterior supporting structures of the lumbar spine during decompressive surgery for lumbar canal stenosis (LCS), lumbar spinous process-splitting laminectomy (LSPSL or split laminectomy) was developed. This prospective, randomized, controlled study was conducted to clarify whether the split laminectomy decreases acute postoperative wound pain compared with conventional laminectomy. Methods. Forty-one patients with LCS were enrolled in this study. The patients were randomly assigned to either the LSPSL group (22 patients) or the conventional laminectomy group (19 patients). Questionnaires regarding wound pain (intensity, depth, and duration) and activities of daily living (ADL) were administered at postoperative days (PODs) 3 and 7. Additionally, the authors evaluated the pre- and postoperative serum levels of C-reactive protein and creatine phosphokinase, the amount of pain analgesics used during a 3-day postoperative period, and the muscle atrophy rate measured on 1-month postsurgical MR images. Results. Data obtained in patients in the LSPSL group and in 16 patients in the conventional laminectomy group were analyzed. The mean visual analog scale for wound pain on POD 7 was significantly lower in the LSPSL group (16 ± 17 mm vs 34 ± 31 mm, respectively; p = 0.04). The mean depth-of-pain scores on POD okinase level was significantly lower in the LSPSL group (126 ± 93 U/L) than in the other group (207 ± 150 U/L) (p = 0.02); on POD 7, the mean serum C-reactive protein level was significantly lower in the LSPSL group (1.1 ± 0.6 mg/dl) than in the conventional laminectomy group (1.9 ± 1.5 mg/dl) (p = 0.04). The number of pain analgesics taken during the 3-day postoperative period was lower in the LSPSL group than in the conventional laminectomy group (1.7 ± 1.3 tablets vs 2.3 ± 2.4 tablets, respectively; p = 0.22). The mean muscle atrophy rate was also significantly lower in the LSPSL group (24% ± 15% vs 43% ± 22%; p = 0.004). Conclusions. Lumbar spinous process-splitting laminectomy for the treatment of LCS reduced acute postoperative wound pain and prevented postoperative muscle atrophy compared with conventional laminectomy, possibly because of minimized damage to the paraspinal muscles.

Primary study

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Authors Celik SE , Celik S , Göksu K , Kara A , Ince I
Journal Journal of spinal disorders & techniques
Year 2010
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Study Design: The 2 groups of patients with severe lumbar spinal stenosis were prospectively compared as a case control study. Objectives: This prospective case control study sought to evaluate bilateral microdecompressive laminatomy (MDL) for treatment of severe lumbar spinal stenosis. Summary of Background Data: Total laminectomy is a general consensus on the therapy of severe spinal stenosis. The authors tried to investigate a new minimal invasive approach. Methods: Patients were randomly divided into 2 groups. In first group, 34 patients underwent total laminectomy (TL) for severe lumbar spinal stenosis. In the second group, 37 patients with the same diagnosis underwent bilateral MDL. The groups were compared for disability, walking distance, degree of postoperative back and leg pain, perioperative complications, and postoperative instability. Radiographic analyses were performed at regular intervals to demonstrate satisfactory decompression. Results: Mean follow-up was 5 years. Postoperative computerized tomography and magnetic resonance imaging demonstrated adequate decompressions in both groups. The walking distance, pain control, and disability scores were slightly higher among patients in the MDL group, although these results did not achieve statistical significance. Perioperative complications and postoperative instability were significantly higher in the TL group (P<0.05). Conclusions: Compared with classic approaches, bilateral MDL provides adequate and safe decompression in lumbar spinal stenosis. It significantly reduces clinical symptoms and disability. However, TL shows higher perioperative complications and postoperative instability. To the best of our knowledge, this is the first study to define a bilateral MDL approach to treat the stenotic lumbar spine without a herniated disc. © 2010 by Lippincott Williams & Wilkins.

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Authors Chopko B , Caraway DL
Journal Pain physician
Year 2010
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BACKGROUND: Neurogenic claudication due to lumbar spinal stenosis is a common problem that can be caused by many factors including hypertrophic ligamentum flavum, facet hypertrophy, and disc protrusion. When standard medical therapies such as pain medication, epidural steroid injections, and physical therapy fail, or when the patient is unwilling, unable, or not severe enough to advance to more invasive surgical procedures, both physicians and patients are often left with a treatment dilemma. Patients in this study were treated with mild, an ultra-minimally invasive lumbar decompression procedure using a dorsal approach. The mild procedure is performed under fluoroscopic imaging to resect bone adjacent to, and achieve partial resection of, the hypertrophic ligamentum flavum with minimal disruption of surrounding muscular and skeletal structure. OBJECTIVE: To assess the clinical application and patient safety and functional outcomes of the mild lumbar decompression procedure in the treatment of symptomatic central canal spinal stenosis. STUDY DESIGN: Multi-center, non-blinded, prospective clinical study. SETTING: Fourteen US spine specialist practices. METHODS: Between July 2008 and January 2010, 78 patients were enrolled in the MiDAS I Study and treated with the mild procedure for lumbar decompression. Of these patients, 6-week follow-up was available for 75 patients. OUTCOME ASSESSMENT: Visual Analog Score (VAS), Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and SF-12v2 Health Survey. Outcomes were assessed at baseline and 6 weeks post-treatment. RESULTS: There were no major device or procedure-related complications reported in this patient cohort. At 6 weeks, the MiDAS I Study showed statistically and clinically significant reduction of pain as measured by VAS, ZCQ, and SF-12v2. In addition, improvement in physical function and mobility as measured by ODI, ZCQ, and SF-12v2 was statistically and clinically significant in this study. LIMITATIONS: This is a preliminary report encompassing 6-week follow-up. There was no control group. CONCLUSIONS: In this 75-patient series, and in keeping with a previously published 90-patient safety cohort, the mild procedure proved to be safe. Further, based on near-term follow-up, the mild procedure demonstrated efficacy in improving mobility and reducing pain associated with lumbar spinal canal stenosis.

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Journal Minimally invasive neurosurgery : MIN
Year 2010
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BACKGROUND: Interspinous stand-alone implants are inserted without open decompression to treat symptomatic lumbar spinal stenosis (LSS). The insertion procedure is technically simple, low-risk, and quick. However, the question remains whether the resulting clinical outcomes compare with those of microsurgical decompression, the gold standard. MATERIAL AND METHODS: This prospective, comparative study included all patients (n=36) with neurogenic intermittent claudication (NIC) secondary to LSS with symptoms improving in forward flexion treated operatively with either interspinous stand-alone spacer insertion (Aperius (®); Medtronic, Tolochenaz, Switzerland) (group 1) or microsurgical bilateral operative decompression (group 2) between February 2007 and November 2008. Data (patient data, operative data, COMI, SF-36 PCS and MCS, ODI, and walking tolerance) were collected preoperatively as well as at 6 weeks, at 3, 6, and 9 months, and at one year follow-up (FU). All patients had complete FU over 1 year. RESULTS: Compared to preoperative measurements, surgery led to improvements of all parameters in the entire collective as well as both individual groups. There were no statistically relevant differences between the 2 groups over the entire course of FU. However, improvements in the ODI and SF-36 MCS were not significant in group 1, in contrast to those of group 2. Also, although in group 1 the improvements in leg pain (VAS leg) were still significant (p<0.05) at 6 months, this was no longer the case at 1 year FU. In group 1 at 1 year FU an increase in leg pain was observed, while in group 2,  minimal improvements continued. Walking tolerance was significantly improved at all FU times compared to preoperatively, regardless of group (p<0.01). At no time there was a significant difference between the groups. In group 1, admission and operative times were shorter and blood loss decreased. The complication rate was 0% in group 1 and 20% in group 2, however reoperation was required by 27.3% of group 1 patients and 0% of group 2. CONCLUSION: Implantation of an interspinous stand-alone spacer yields clinical success comparable to open decompression, at least within the first year of FU. The 1-year conversion rate of 27.3% is, however, decidedly too high.

Primary study

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Journal Clinical rehabilitation
Year 2010
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OBJECTIVE: To assess the effectiveness of therapeutic exercises alone and in combination with a single physical agent - ultrasound - in patients with lumbar spinal stenosis. DESIGN: Randomized, prospective, controlled trial. SETTING: Department of Physical Medicine and Rehabilitation, University Hospital. Subjects: Forty-five patients presenting with symptoms of neurological claudication and magnetic resonance image-proven lumbar spinal stenosis were assigned to one of three groups: ultrasound plus exercise group (group 1, n = 15), sham ultrasound plus exercise group (group 2, n = 15) and no exercise - no treatment group (control group, n = 15). INTERVENTIONS: Stretching and strengthening exercises for lumbar, abdominal, leg muscles as well as low-intensity cycling exercises were given as therapeutic exercises. Ultrasound was applied with 1 mHz, 1.5W/cm² intensity, in continuous mode on the back muscle for 10 minutes in group 1 while ultrasound on/off mode was applied in group 2. Main outcome measures: Before and after a three-week period, all subjects were evaluated by pain, disability, functional capacity and consumption of analgesic. RESULTS: Thirty-two of the participants were women and 13 were men, with an average age of 53.2 ± 12.68 years (range 25-82 years). After a three-week treatment period, leg pain decreased in group 1 (-1.47 ± 3.02) and group 2 (-2.47 ± 3.75) compared with the control group (P&lt;50.05). Disability score decreased in group 1 (-3.94 ±7.20) and group 2 (-7.80 ± 10.26) compared with control group (P&lt;50.05). We did not find any statistically significant difference between groups 1 and 2 (P&lt;40.05). The amount of analgesic consumption is significantly less in the group with ultrasound application compared to that in the control group (P&gt;50.05). CONCLUSION: The results of our study suggest that therapeutic exercises are effective for pain and disability in patients with lumbar spinal stenosis and that addition of ultrasound to exercise therapy lowers the analgesic intake substantially.

Primary study

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Journal Spine
Year 2009
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STUDY DESIGN.: Randomized single-blind controlled trial. OBJECTIVE.: We aimed to compare the effects of epidural steroid injections and physical therapy program on pain and function in patients with lumbar spinal stenosis (LSS). SUMMARY OF BACKGROUND DATA.: LSS is one of the most common degenerative spinal disorders among elderly population. Initial treatment of this disabling painful condition is usually conservative including analgesics, nonsteroidal anti-inflammatory drugs, exercise, physical therapy, or epidural steroid injections. Owing to lack of sufficient data concerning the effectiveness of conservative treatment in LSS, we aimed to compare the effectiveness of epidural steroid injections and physical therapy program in a randomized controlled manner. METHODS.: A total of 29 patients diagnosed as LSS were randomized into 3 groups. Group 1 (n = 10) received an inpatient physical therapy program for 2 weeks, group 2 (n = 10) received epidural steroid injections, and group 3 (n = 9) served as the controls. All study patients additionally received diclofenac and a home-based exercise program. The patients were evaluated at baseline, 2 weeks, 1 month, 3 months, and 6 months after treatment by finger floor distance, treadmill walk test, sit-to-stand test, weight carrying test, Roland Morris Disability Index, and Nottingham Health Profile. RESULTS.: Both epidural steroid and physical therapy groups have demonstrated significant improvement in pain and functional parameters and no significant difference was noted between the 2 treatment groups. Significant improvements were also noted in the control group. Pain and functional assessment scores (RMDI, NHP physical activity subscore) were significantly more improved in group 2 compared with controls at the second week. CONCLUSION.: Epidural steroid injections and physical therapy both seem to be effective in LSS patients up to 6 months of follow-up. © 2009, Lippincott Williams & Wilkins.

Primary study

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Authors Yagi M , Okada E , Ninomiya K , Kihara M
Journal Journal of neurosurgery. Spine
Year 2009
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Object. The object of this study was to assess the feasibility and efficacy of a novel, minimally invasive spinal surgery technique to correct degenerative lumbar spinal stenosis involving a modified unilateral-approach microendoscopic midline decompression. Methods. In this prospective study, 41 patients with lumbar stenosis were randomly assigned to undergo either a novel, median-approach microendoscopic laminectomy (20 patients) or a conventional laminectomy (21 patients). Spinal anteroposterior diameter, cross-sectional area, lateral recess distance, spinal stability, postoperative back pain, functional outcomes, and muscle trauma were evaluated. Follow-up ranged from 16 to 24 months, with a mean of 17.8 months for the novel procedure group and 18.6 months for the conventional laminectomy group. Results. Compared with patients in the conventional laminectomy group, patients who received the novel procedure had a reduced mean duration of hospital stay, a lower mean creatine phosphokinase muscular-type isoenzyme level, a lower visual analog scale score for back pain at 1-year follow-up, and a faster recovery rate. These patients also had less mean blood loss compared with the conventionally treated group. Satisfactory neurological decompression and symptom relief were achieved in 90% of these patients. There was no significant clinical difference compared with the conventional laminectomy group's results. There was no evidence of spinal instability in any patient, and no patient required a follow-up conventional laminectomy. Conclusions. This novel procedure provides effective spinal decompression. Although this method requires more operating time than a conventional method, it requires only minimal muscle trauma and spinal stability maintenance, and allows for early mobilization. This shortens the hospital stay, reduces postoperative back pain, and leads to satisfactory neurological and functional outcomes. Moreover, with the midline approach, decompression was accomplished without compromising the facet joints, even with a narrow width of lamina.