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      Disc Volume Reduction with Percutaneous Nucleoplasty in an Animal Model

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          Abstract

          Study Design

          We assessed volume following nucleoplasty disc decompression in lower lumbar spines from cadaveric pigs using 7.1Tesla magnetic resonance imaging (MRI).

          Purpose

          To investigate coblation-induced volume reductions as a possible mechanism underlying nucleoplasty.

          Methods

          We assessed volume following nucleoplastic disc decompression in pig spines using 7.1-Tesla MRI. Volumetry was performed in lumbar discs of 21 postmortem pigs. A preoperative image data set was obtained, volume was determined, and either disc decompression or placebo therapy was performed in a randomized manner. Group 1 (nucleoplasty group) was treated according to the usual nucleoplasty protocol with coblation current applied to 6 channels for 10 seconds each in an application field of 360°; in group 2 (placebo group) the same procedure was performed but without coblation current. After the procedure, a second data set was generated and volumes calculated and matched with the preoperative measurements in a blinded manner. To analyze the effectiveness of nucleoplasty, volumes between treatment and placebo groups were compared.

          Results

          The average preoperative nucleus volume was 0.994 ml (SD: 0.298 ml). In the nucleoplasty group (n = 21) volume was reduced by an average of 0.087 ml (SD: 0.110 ml) or 7.14%. In the placebo group (n = 21) volume was increased by an average of 0.075 ml (SD: 0.075 ml) or 8.94%. The average nucleoplasty-induced volume reduction was 0.162 ml (SD: 0.124 ml) or 16.08%. Volume reduction in lumbar discs was significant in favor of the nucleoplasty group (p<0.0001).

          Conclusions

          Our study demonstrates that nucleoplasty has a volume-reducing effect on the lumbar nucleus pulposus in an animal model. Furthermore, we show the volume reduction to be a coblation effect of nucleoplasty in porcine discs.

          Related collections

          Most cited references28

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          Are animal models useful for studying human disc disorders/degeneration?

          Intervertebral disc (IVD) degeneration is an often investigated pathophysiological condition because of its implication in causing low back pain. As human material for such studies is difficult to obtain because of ethical and government regulatory restriction, animal tissue, organs and in vivo models have often been used for this purpose. However, there are many differences in cell population, tissue composition, disc and spine anatomy, development, physiology and mechanical properties, between animal species and human. Both naturally occurring and induced degenerative changes may differ significantly from those seen in humans. This paper reviews the many animal models developed for the study of IVD degeneration aetiopathogenesis and treatments thereof. In particular, the limitations and relevance of these models to the human condition are examined, and some general consensus guidelines are presented. Although animal models are invaluable to increase our understanding of disc biology, because of the differences between species, care must be taken when used to study human disc degeneration and much more effort is needed to facilitate research on human disc material.
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            A prospective cohort study of close interval computed tomography and magnetic resonance imaging after primary lumbar discectomy: factors associated with recurrent disc herniation and disc height loss.

            Prospective cohort study. We performed a prospective cohort study with standardized postoperative lumbar imaging every 3 months for a year then annually to assess the incidence and factors associated with same-level recurrent disc herniation. The true incidence of same-level recurrent disc herniation after lumbar discectomy is unclear. Retrospective studies have reported widely varying incidences between 3% and 18%. Prospective controlled studies are lacking. A total of 108 patients undergoing first-time lumbar discectomy for refractory radiculopathy were enrolled. Baseline lumbar CT and MRI and standardized clinical data were assessed before surgery, and CT and MRI scans repeated 6 weeks, 3, 6, 9, 12, and 24-months after surgery and at the time of recurrent sciatica. Age, weight, preoperative disc volume, and height, volume of disc removed, and size of anular defect were compared with postoperative disc height loss and recurrent disc herniation using regression analysis. One hundred patients (41 +/- 10 years old) were available for 1-year (93%) and 76 (70%) for 2-year follow-up (mean follow-up: 25 +/- 12 months). Improvement in all outcome measures was observed by 6 weeks after surgery (P < 0.005). An 18% loss of disc height was observed 3 months after surgery, progressing to 26% by 2 years. Eleven (10.2%) patients experienced recurrent disc herniation requiring revision discectomy a mean 10.5 months after surgery. Subjects with larger anular defects (P = 0.019) and with smaller percentage of disc volume removed (P = 0.028) were associated with an increased risk of recurrent disc herniation. Conversely, those from whom greater disc volumes were removed (P = 0.024) had more progressive disc height loss by 6 months after surgery. Larger anular defects and less disc removal increased the risk of reherniation. Greater volumes of disc removal were associated with accelerated disc height loss. In the setting of larger anular defects or less aggressive disc removal, concern for recurrent herniation should be increased during outpatient follow-up. In this situation effective anular repair may be helpful.
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              A metaanalysis of the effectiveness and safety of ozone treatments for herniated lumbar discs.

              To determine statistically significant effects of oxygen/ozone treatment of herniated discs with respect to pain, function, and complication rate. Random-effects metaanalyses were used to estimate outcomes for oxygen/ozone treatment of herniated discs. A literature search provided relevant studies that were weighted by a study quality score. Separate metaanalyses were performed for visual analog scale (VAS), Oswestry Disability Index (ODI), and modified MacNab outcome scales, as well as for complication rate. Institutional review board approval was not required for this retrospective analysis. Twelve studies were included in the metaanalyses. The inclusion/exclusion criteria, patient demographics, clinical trial rankings, treatment procedures, outcome measures, and complications are summarized. Metaanalyses were performed on the oxygen/ozone treatment results for almost 8,000 patients from multiple centers. The mean improvement was 3.9 for VAS and 25.7 for ODI. The likelihood of showing improvement on the modified MacNab scale was 79.7%. The means for the VAS and ODI outcomes are well above the minimum clinically important difference and the minimum (significant) detectable change. The likelihood of complications was 0.064%. Oxygen/ozone treatment of herniated discs is an effective and extremely safe procedure. The estimated improvement in pain and function is impressive in view of the broad inclusion criteria, which included patients ranging in age from 13 to 94 years with all types of disc herniations. Pain and function outcomes are similar to the outcomes for lumbar discs treated with surgical discectomy, but the complication rate is much lower (<0.1%) and the recovery time is significantly shorter. Copyright 2010 SIR. Published by Elsevier Inc. All rights reserved.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, USA )
                1932-6203
                2012
                27 November 2012
                : 7
                : 11
                : e50211
                Affiliations
                [1 ]Clinic and Outpatient Clinic for Orthopedics and Orthopedic Surgery, Greifswald University Medicine, Greifswald, Germany
                [2 ]Department of Diagnostic Radiology and Neuroradiology, Greifswald University Medicine, Greifswald, Germany
                [3 ]Department of Spine Surgery and Pain Therapy, Center for Orthopedics and Traumatology, St Anna-Hospital Herne, Herne, Germany
                [4 ]Department of Orthopaedics and Trauma Surgery, Asklepios Hospital Uckermark, Schwedt, Germany
                [5 ]Department of Orthopedic Surgery, University Medical Center of Rostock, Rostock, Germany
                University of California Los Angeles, United States of America
                Author notes

                Competing Interests: The authors have the following interests: ArthroCare Deutschland, Reimscheid, provided the technical equipment needed for nucleoplasty. The authors received for the project the nucleoplasty Convenience Pack (DLR SpineWand and sterile 17-gauge Crawford needle (6") with mandrin) from ArthroCare Germany. There are no further patents, products in development or marketed products to declare. This does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials.

                Conceived and designed the experiments: R. Kasch HRM R. Kayser. Performed the experiments: BM FS RS HRM. Analyzed the data: R. Kasch BM FS SR TB SF RS HRM R. Kayser. Contributed reagents/materials/analysis tools: R. Kasch BM FS RS. Wrote the paper: R. Kasch BM TB SR SF HRM R. Kayser.

                Article
                PONE-D-12-21172
                10.1371/journal.pone.0050211
                3507698
                23209677
                2595d277-daef-4108-b89f-736bd2e7c6df
                Copyright @ 2012

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 16 July 2012
                : 17 October 2012
                Page count
                Pages: 8
                Funding
                The authors would like to thank ArthroCare Deutschland, Reimscheid, Germany for providing the technical equipment needed for nucleoplasty. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. No additional external funding sources for this study.
                Categories
                Research Article
                Medicine
                Anatomy and Physiology
                Musculoskeletal System
                Musculoskeletal Anatomy
                Neurological System
                Central Nervous System
                Nervous System Components
                Neuroanatomy
                Anesthesiology
                Neurosurgical Care
                Pain Management
                Clinical Research Design
                Animal Models of Disease
                Neurology
                Spinal Cord Diseases
                Radiology
                Diagnostic Radiology
                Magnetic Resonance Imaging
                Interventional Radiology
                Surgery
                Neurosurgery
                Orthopedic Surgery

                Uncategorized
                Uncategorized

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