Surgical Treatment for Lumbar Spinal Stenosis Dynamic Interspinous Distraction Interlaminar Stabilization Implant - Coflex

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International 31st Course For Percutaneous Endoscopic Spinal Surgery And Complementary Minimal Invasive Techniques Zurich, Switzerland January 24-25, 2013 Surgical Treatment for Lumbar Spinal Stenosis Dynamic Interspinous Distraction Interlaminar Stabilization Implant - Coflex John C Chiu, MD, FRCS (US), DSc Chief, Neurospine Surgery California Spine Institute Thousand Oaks, California, USA President AAMISMS spinecenter.com

Introduction: Lumbar Spinal Stenosis (LSS): 1.5 m people diagnosed with LSS each year in the USA and growing due to aging boomers It is one of the most common indications for spinal surgeries in patients over 55 years old Degenerative LSS caused by hypertrophic ligamentum flavum, facet hypertrophy and disc protrusion, are common in an aging population

Introduction: Lumbar stenosis - descriptive term denoting narrowing of the spinal canal as result of degenerative aging spine with central and lateral stenosis LSS leading to intermittent neurogenic claudication (INC) includes pain, numbness, and weakness that are worse with ambulation and improve on rest and spinal flexion MRI scanning is single imaging modality of choice to delineate the severity of neural compression Segmental instability in some cases- spondylolisthesis

Introduction: Non-operative treatment includes physical therapy spinal flexion exercises, aerobic conditioning, administration of non-steroid anti-inflammatory drugs, and epidural steroid injections The natural history of the disease is associated with deterioration of symptoms When conservative treatment, at least 6 months fails Many types of lumbar decompressive spinal surgery and fixation have been developed

Classification of LSS: Etiological Classification 1. Congenital or Developmental (e.g. short pedicle) 2. Acquired stenosis (or due to degenerative spinal stenosis) Anatomical Classification 1. Used to identify specific area of narrowing 2. Particularly useful as a guide for surgical decompression 3. The anatomy of spinal canal at each vertebral segments can be divided into three transverse level (are the pedicle levels, the intermediate foraminal and the disc level and five different sagital zones Anatomical grid to evaluate spinal stenosis

Classification by Pathophysiology: Central spinal stenosis commonly occurs at the disc and upper pedicle level as the result of facet joint hypertrophy and the hypertrophic ligamentum flavum Lateral spinal stenosis affects the lateral recess zone and intervertebral foramen Stenosis rarely occurs at the pedicle level except extruded disc and congenitally short pedicles Stenosis of the intervertebral foramen is most common at the disc level, usually in the inferior portion of the foramen, especially when it involves the superior aspect of the foramen at the intermediate level where the exit nerve root passes laterally Lateral recess stenosis occurs as the result of degenerative changes effecting the nerve root canal at the disc level and superior aspect of the pedicle level Lateral recess stenosis at the inferior aspect of the pedicle level is uncommon

Coflex Design Rationale Implant for Treatment of LSS: The Coflex system/procedure, is a minimally invasive dynamic interlaminar distraction/stabilization system, designed for treatment of LSS Functionally dynamic - Preserving spinal motion by being compressible in extension, absorbing axial force shock, maintaining sagittal balance and lordosis, and maintaining physiological adjacent segmental kinematics Allowing flexion and increased rotational stability It maintains neural foraminal height and off loads facet joint and posterior annulus with reduction of stress on facet joints

Minimally Invasive Surgical Treatment for LSS with Coflex Implant and Lumbar Microdecompression

Surgical Indications: The surgical indication for Coflex implant: Age 50 or older Significant intermittent neurogenic claudication (INC) Evidence of LSS with x-ray, MRI scan and/or CT scan Not responding to at least six months of conservative treatment - Failed Spinal flexion gives relief Often grocery cart syndrome for relief of low back and leg pain

Surgical Indications: Symptomatic lumbar post fusion disc herniation Lumbar post fusion Junctional Disc Herniation Syndrome (JDHS) or Adjacent Segment Disease (ASD) JDHS - large L3-4 disc herniation into right lateral recess and neural foramen of 8mm in size spinecenter.com

Surgical Procedure/Technique Pre-op Prep Anesthesia Patient Positioning Local anesthesia and monitored IV conscious sedation or general anesthesia 2 grams Ancef and 8 mg dexamethasone IV pre-op Surface EEG monitoring (BIS) IOM - EEG, EMG to prevent undue neural trauma Patient positioning: is usually positioned on a set of bolsters in a prone position A head-holder with a mirror is used to support and to stabilize the patients head spinecenter.com

Surgical Procedure/Technique Lumbar spinal decompression Lumbar midline approach Preservation of supraspinous ligament Muscle and fascia are sharply dissected lateral to the supraspinous ligament Paraspinal muscles are stripped off the laminae Interspinous ligament is sacrificed Any bony overgrowth of the spinous process is resected to prepare for the implant Lumbar decompressive laminectomy to relieve neural compression By excision of hypertrophic ligamentum flavum, partial facetectomy, and decompressive neuroforaminotomy with a curved Kerrison ronguer spinecenter.com

Surgical Procedure/Technique Measuring and Inserting of COFLEX Implant Insertion of Coflex down to facet joint level, 3mm posterior to dura Measuring the space Crimping the wings and inserting implant spinecenter.com

Surgical Procedure/Technique Coflex F: if needed for stabilization/fixation with screw and sleeves spinecenter.com

Surgical Procedure/Technique One Level or More COFLEX Implantation 1 Level 2 Level spinecenter.com

Surgical Procedure/Technique Wound Closure In the. usual manner Muscle, fascia and the supraspinous ligament can be resutured and closed in one layer over the spinous processes spinecenter.com

LSS for Spinal Instability Coflex F can Combine with other Lumbar Decompression/Fusion Techniques

Surgical Procedure/Technique Interbody Fusion and T-LIF (Transforaminal) Rampart interbody (PEEK) fusion system

Surgical Procedure/Technique Spinal Facet Fusion Facet screw fixation Bony fusion after denuding and decorticating facet joints Capture Facet Fixation System Viper Facet Screw Fixation

Surgical Procedure/Technique: Biologic morcelized bone graft OptiMesh Implant as Intervertebral/Disc Spacer/Fusion

Surgical Procedure/Technique: DIAM Interspinous Implant Wallis Device X-stop spacer Superion Interspinous Spacer System spinecenter.com

Case Illustrations: LUMBAR STENOSIS TREATED WITH LUMBAR DECOMPRESSION AND COFLEX IMPLANTS spinecenter.com

Case Illustration I LUMBAR STENOSIS TREATED WITH LUMBAR DECOMPRESSION AND ONE COFLEX IMPLANT Severe lumbar stenosis 73 yo with severe rapid progressive (in 6 mos.) neurogenic claudication, leaning on grocery cart syndrome Successfully treated with microdecompressive discectomy and interspinous spacer Coflex-f with facet fusion Able to stand and walk unassisted and straight spinecenter.com

Case Illustration II LUMBAR STENOSIS TREATED WITH LUMBAR DECOMPRESSION AND ONE COFLEX IMPLANT 1 level lumbar stenosis caused by: Disc herniation Anterior offset of L4 over L5 hypertrophy of the ligamentum flavum Neuro-foraminal stenosis Successfully treated with MISS microdecompression Coflex-F interspinous spacer/fixation & lumbar facet fusion with relief of neurogenic claudication & correction of stooped posture Coflex-F Spacer/Fixation 77 y o male with severe L4-5 lumbar stenosis, stooped posture & neurogenic claudication relieved by Coflex-F fixation & lumbar facet fusion

Case Illustration III LUMBAR STENOSIS TREATED WITH LUMBAR DECOMPRESSION AND TWO COFLEX IMPLANTS 81 y o female with progressive severe neurogenic claudication secondary to L3 & L4 LSS relieved by Lumbar decompression, Coflex fixation & lumbar facet fusion with relief of neurogenic claudication & correction of stooped posture Coflex-F Spacer/Fixation

Case Illustration IV LUMBAR STENOSIS TREATED WITH LUMBAR DECOMPRESSION AND THREE COFLEX IMPLANTS 3 level lumbar stenosis caused by: Disc herniation Anterior offset of L4 over L5 hypertrophy of the ligamentum flavum Neuro-foraminal stenosis Successfully treated with MISS microdecompression Coflex-F interspinous spacer/fixation & lumbar facet fusion with relief of neurogenic claudication & correction of stooped posture Coflex-F Spacer/Fixation 59 year old office manager with severe L2-3, L3-4 & L4-5 lumbar stenosis, stooped posture & neurogenic claudication relieved by MISS, Coflex-F fixation & lumbar facet fusion

Post Operative Care: Ambulatory within one hour and discharged subsequently May shower the following day Usually patient has relief of neurogenic claudication immediately after surgery with improved Ice pack is helpful Mild analgesics and muscle relaxant are required at times Progressive spine exercise second post operative day on Responds to postoperative treatment with significant improvement of VAS, ODI, and patient satisfaction score

Discussion and Comment: The author s personal experience with this out patient Coflex system for treatment of LSS has been positive The Coflex procedure combined with lumbar decompression provides excellent symptomatic relief of INC, low back and pain, symptoms related to LSS, and improves mobility with much less trauma With the following additional advantages for Coflex: Less traumatic and minimal blood loss Preserves spinal motion Small incision Economic savings due to earlier return to work Local anesthesia/iv sedation usually Early post op exercise Multiple levels can be performed at one sitting Can be performed for high risk patients including morbid obesity, emphysema, and cardiac conditions with much less risk Intra-operative neurophysiological/emg monitoring, and direct visualized endoscopic significantly reduces the chance for inadvertent injury of neural structure Shorter hospital stay

Discussion and Comment: Other Types of Lumbar Stenosis Decompression Surgeries being utilized: 1. Decompressive Lumbar Stenosis: Minimally Invasive Lumbar Decompression 2. Traditional wide decompressive lumbar laminectomy with and without instrument fixation/fusion traumatic open surgery 3. Static lumbar stabilization systems X-Stop Vertiflex Facet Screw/fixation/fusion 4. Dynamic stabilization Coflex/Coflex-F DIAM dynamic stabilization WALLIS Interspinous Device 5. Others

Conclusion: Coflex procedure combined with lumbar microdecompression provides excellent relief of LSS symptoms and INC It is a safe, effective and less traumatic spinal surgery with a dynamic distraction/stabilization implant It avoids the more traumatic open spinal surgery and is a treatment a option for treatment option for treating moderate to severe degenerative LSS It is a smart way to treat symptomatic LSS

Hope you enjoyed this presentation! Thank you for your attention! Danke schön Arigato Thank you Merci Cám ón Gracias John C. Chiu, M.D., FRSC (US), D.Sc. California Spine Institute