5. Intervertebral Lumbar Disc Fibrocartilaginous joint of the motion segment Present at levels L1-S1 Allows compressive, tensile, and rotational motion Largest avascular structures in the body
6. Intervertebral Lumbar Disc The Disc is Comprised of: Nucleus Pulposus – soft, gel-like inner substance. Anulus Fibrosus – tough, outer ring that contains the nucleus pulposus.
16. Herniated Disc Herniated disc, or “ruptured disc” is one of the most frequently surgically treated pathologies of the spine. Average patient age is approximately 40 yrs old. Disc herniation is often referred to as HNP, or herniated nucleus pulposus. Not all patients who develop a disc herniation experience pain. Large disc herniation L5-S1
17. L3-4 L4-5 L5-S1 Herniated Disc The most frequently involved sites are those with the greatest range of motion and/or axial loading forces. L3-4, L4-5, and L5-S1 are most common levels for herniated discs.
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19. Exiting nerve root Lumbar Disc Herniation - Sciatic Pain As the outer fibers of the disc become distorted, the disc may protrude, extrude or fragment into the spinal canal. This puts the disc herniation a position to physically contact and exert pressure on the exiting nerve root. The individual may begin experiencing sciatica, or pain down the back of the leg.
20. Lumbar Disc Herniation - Discogenic Pain Some people experience discogenic back pain, or pain generated from tears in the anulus fibrosus. Most initial tears in the inner anulus are asymptomatic. As the anular split progresses to the outer layers, the individual may begin to experience low back pain, with or without pain in the buttocks and legs. This pain is discogenic in nature and not due to the compression of, or tension on, a nerve root.
21. Treatment of Lumbar Disc Herniation Conservative Treatment Sciatica often resolves spontaneously. Physicians cannot predict which individuals will have natural resolution. Surgical Treatment Surgery is typically considered only after 6 weeks of conservative treatment. These patients often gain immediate relief of their sciatica.
23. Lumbar Discectomy Lumbar Discectomy: Surgical procedure to remove a herniated disc. Most frequently performed spinal surgery – over 800,000 procedures performed worldwide each year. Performed in the inpatient and outpatient hospital as well as ASC settings.
27. Lumbar Discectomy Procedure An Open Pathway or “Hole” is Left in the Anulus: Until recently surgeons have not had a fast or effective way to repair the defect following lumbar discectomy surgery. An open defect can lead to poor patient outcomes.
29. Lumbar Discectomy Outcomes Clinical Literature Post Discectomy 5 Year Outcome1-3 Post Op 30% have pain following Discectomy Limited ability to predict the patients who will have poor outcomes Back Pain Improved 70 % Same or worse 30 % Leg Pain Improved 71 % Same or worse 29 % Satisfied Yes 63 % No 37 % 1Atlas S., et al. Surgical and Nonsurgical Management of Sciatica Secondary to Lumbar Disc Herniation: Five-Year Outcomes from the Maine Lumbar Spine Study. Spine 2001;26:1179-1187. 2Atlas et. al. Long-Term Outcomes of Surgical and Nonsurgical Management of Sciatica to a Lumbar Herniation: 10 Year Results from the Maine Lumbar Spine Study. Spine 2005;30:927-935. 3Loupasis et al. Seven-to-20-Year Outcome of Lumbar Discectomy. Spine 1999;24: pp 2313-2317.
31. Discectomy Re-operation Rates 1Hu R, et al. A Population Based Study of Reoperations After Back Surgery. Spine 1997;22:2265-2271. 2Malter A., et al. 5-Year Reoperation Rates After Different Types of Lumbar Surgery. Spine 1998;23:814-820. 3Atlas S., et al. Surgical and Nonsurgical Management of Sciatica Secondary to Lumbar Disc Herniation: Five-Year Outcomes from the Maine Lumbar Spine Study. Spine 2001;26:1179-1187. 4Osterman H., et al. Risk of Multiple Reoperations After Lumbar Disecectomy: A Population Based Study. Spine 2003;28:621-627. 5Atlas et. al. Long-Term Outcomes of Surgical and Nonsurgical Management of Sciatica to a Lumbar Herniation: 10 Year Results from the Maine Lumbar Spine Study. Spine 2005;30:927-935.
32. Discectomy Outcomes are Affected by Surgical Technique How much nucleus should be removed? 30% pts have continuing pain after discectomy
33. How Much Nucleus Should be Removed? Minimal Discectomy Aggressive Discectomy Pros: Maintenance of Disc Height2,3 Cons: Increased Reherniation1 Pros: Decreased Reherniation1 Cons: Disc Height Collapse2,3 Possible Tradeoffs 1Caragee, E. et al. A Prospective Controlled Study of Limited Vs. Subtotal Posterior Discectomy: Short-Term Outcomes in Patients With Herniated Lumbar Intervertebral Discs and Large Posterior Anular Defect. Spine 2006; 31:653-657. 2Brinckmann P, et al. Change of Disc Height, Radial Disc Bulge, and Intradiscal Pressure from Discectomy. Spine 1991;16(6):641-646. 3Kamaric E, et al. Restoration of Disc Competency by Increasing Disc Height Using an Anular Closure Device. Fifth Global Symposium on Motion Preservation Technology, Spine Arthroplasty Society (SAS) Meeting. New York, May 4-7 2005.
34. Why Perform a Minimal Discectomy? A less aggressive discectomy results in better patient outcomes1,2 An aggressive discectomy results in low early reherniation rates3 but overall poorer patient outcomes1,2 Minimal Discectomy Aggressive Discectomy 1Carragee, et al, March 2006, Spine. 2Barth, et al, February 2008, Spine. 3Wera, et al, February 2008, JBJS.
35. Clinical Evidence in Support of Minimal Techniques & Disc Preservation Carragee Case Series Study Barth Case Series Study
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40. Repair of the Anulus Fibrosus Reduce Reoperations and Improve Patient Outcomes by: Restricting nucleus material from re-extruding1 Reducing inflammation and scar formation2,3 Enabling surgeons to perform a less extensive disc removal4 1Cauthen, JC. Chapter 11. pp 155-177 . In: Spinal Arthroplasty; A New Era in Spine Care, Guyer RD, editor. St. Louis MO: Quality Medical Publishing, 2005. 2Kawakami M, et al. The Role of Phospholipase A2 and Nitric Oxide in Pain-Related Behavior Produced by an Allograft of Intervertebral Disc Material to the Sciatic Nerve of the Rat. Spine 22(10):1074-1079, 1997. 3Omarker K, et al. Pathogenesis of Sciatic Pain: Role of Herniated Nucleus Pulposus and Deformation of Spinal Nerve Root and Dorsal Root Ganglion. Pain 78(2):99-105, 1998. 4Carragee et al. A Prospective Controlled Study of Limited Versus Subtotal Posterior Discectomy: Spine 2006: 31: pp653-657.
41. Clinical Benefits of Anular Repair:Historical Perspective Cauthen J1 Extensive study with focus on reducing reoperations 254 patients series – suggested 21% recurrent herniation at 2 yrs with no suture, <10% with one suture, approx 5% with more than one suture Yasargil MG2 Described placing 7-0 suture in anulus after nucleus removal 105 patients; reported no reherniations, impairment of neurological symptoms, or postoperative radiculopathy Lehmann et al3 Included single 4-0 silk suture to close PLL flaps, peridural membrane and anulus outer fibers 152 patients; greater percentage of patients that were sutured had less post-op pain than patients not sutured; statistical significance not achieved & did not report recurrent herniation or reop rates 1 Cauthen, JC. Chapter 11. Microsurgical Annular Reconstruction (Annuloplasty) Following Lumbar Microdiscectomy: In: Spinal Arthroplasty; A New Era in Spine Care,Guyer RD, editor. St. Louis, MO: Quality Medical Publishing, 2005. 2Yasargil MG. Microsurgical operation of herniated lumbar disc. Advances in Neurosurgery 4:81, 1977. 3Lehmann TR, Titus MK. Refinements in technique for open lumbar discectomy. Proceedings of the International Society for the Study of the Lumbar Spine (ISSLS), June 1997.
42. Anular Repair- Cauthen Experience Suture Repair Technique – 2 Year Follow-up1 % Reop Rate Reduction of 68% Percent Recurred Surgical Group Slit style anulotomy with anular repair results in favorable outcomes, but can be surgically challenging & time consuming (45 min OR time) 1 Cauthen, JC. Chapter 11. Microsurgical Annular Reconstruction (Annuloplasty) Following Lumbar Microdiscectomy: In: Spinal Arthroplasty; A New Era in Spine Care,Guyer RD, editor. St. Louis, MO: Quality Medical Publishing, 2005.
43. Shift in Type of Anulotomy Performed Vertebra Box Slit Disc Vertebra Discectomy often done through pre-existing anular tear When anular tear is not evident (e.g., contained disc), anulotomy should be performed with minimally-adequate intention
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45. Over 10,000 procedures done in the U.S.Soft tissue T-anchor assemblies Tension lines INDICATIONS: The Xclose™ Plus Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic procedures.
50. Versaclose™ Surgical TechniqueFive Primary Steps 1. Insert/Deploy Versaclose anchor 2. Insert/Deploy 1st Xclose Plus Anchor 4. Remove Slack to re-approximate Xclose Plus tension line 3. Insert/Deploy 2nd Xclose Plus Anchor 5. Remove Slack to re-approximate Versaclose tension line
51. Clinical Benefits of Anular Repair: Contemporary Perspective Hartman L, et al (2009)1 Surgical Outcome of Lumbar Microdiscectomy with Emphasis on the Benefit of Anular Repair Techniques Bailey A, et al (2010)2 Prospective, Randomized Controlled Study of Repairing the Anulus Fibrosus after Lumbar Discectomy: A Single Surgeon’s Experience Araghi A, et al (2010)3 The Effect of Anular Repair on Sciatica Patients Receiving a Micro-Discectomy Procedure 11Hartman L, Griffith S., Melone B., Melone D. Surgical Outcome of Lumbar Microdiscectomy with Emphasis on the Benefit of Anular Repair Techniques. Proceeding of the Congress of Neurological Surgeons (CNS), October 2009, New Orleans, LA. 2Bailey A, et al Prospective, Randomized Controlled Study of Repairing the Anulus Fibrosus after Lumbar Discectomy: A Single Surgeon’s Experience. 3Araghi A, et al The Effect of Anular Repair on Sciatica Patients Receiving a Micro-Discectomy Procedure, Proceedings of the SAS, April, 2010, New Orleans, LA.
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55. Clinical Benefits of Anular Repair:Post-Market Study Endpoints Primary Endpoint: - Reoperation rates; specifically those for reherniation Secondary Endpoints: - Oswestry Disability Index Score - Visual Analog Scale - Quality of Life (SF-12) - Health Care Utilization - Pain medications - Return to work - Disc height collapse - All cause adverse events Study Enrollment was completed as of August ’09 - Patient outcomes are currently being tracked
58. Recurrent Lumbar Disc Herniation After Single-Level Lumbar Discectomy: Incidence and Health Care Cost Analysis Study purpose: Identify the incidence and health care costs of same-level recurrent disc herniation after primary lumbar discectomy Costs are defined as billed charges Article included in Neurosurgery: Sept. 2009, Volume 65, No. 3, pp 574-578
59. Recurrent Lumbar Disc Hernation After Single-Level Lumbar Discectomy: Incidence and Health Care Cost Analysis A retrospective study performed by Ambrossi, et. al. at Johns Hopkins Hospital. Study identified the incidence and health care costs of same-level recurrent disc herniation after primary lumbar discectomy. Costs included Epidural steroid injections (ESI) Imaging studies (MRI, CT, Myelograms, plain films) Repeat surgery including hospitalization costs Inpatient and outpatient physical therapy 156 patients were reviewed and 141 were available for 1 year follow-up. 17 patients (12%) developed a same-level recurrent disc herniation. Of these 17 patients, 11 (7.8%) required revision surgery, and 6 patients (4.2% responded to conservative therapy).
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61. Of the 11 that had revision surgery, the cost was $39,836 per patient.
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64. The ability to repair the anulus quickly and efficiently offers confidence to preserve and contain disc material and potentially improve patient outcomes
