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Axia lif patient brochure english Axia lif patient brochure english Document Transcript

  • Back toLivingA patient’sguide tolow backpain
  • If you’ve been struggling with back pain The least invasive solution to lumbar fusionthen you know firsthand the impact that thepain can have on your life. Fortunately thereare advancements in treating back pain that,after conservative treatments have failed,can help ease your pain and help get youback to living.A new fusion procedure called AxiaLIF® ischanging the way many doctors approachspine fusion — and is making the road torecovery for patients much easier.Unlike the open spine surgeries of the past, theAxiaLIF® procedure gives surgeons the abilityto stabilize painful joints in the spine throughvery small incisions. The procedure spares themuscles and supporting soft-tissues of thespine which means less surgical trauma and anoverall less painful post-operative experience— many patients are released from the hospitalthe day after surgery.This guide to low-back pain has beendeveloped to help patients betterunderstand how the spine works, andthe conditions that may be causing theirpain. Along with highlighting the variousprocedures used to treat pain in the lumbarspine, this guide will introduce you to theAxiaLIF® procedure that is changing theway people think about back surgery —and helping them get back to living.The information in this guide is provided for generaleducation and is not intended to replace professionalmedical care or advice. Only your physician and/or surgeonis qualified to diagnose or recommend treatment for yourpain or related conditions.
  • TheTable of HealthyContents SpineThe Healthy Spine 5 Understanding the Low Back 7 How We Talk About the Spine 7 The Bones in the Lumbar Spine 8 The Bones in the Sacral Spine 8 The Vertebrae 9 Intervertebral Discs 10 The Spinal Cord and Nerve Roots 11 Facet Joints 12Conditions Causing Low Back Pain 13 Degenerative Disc Disease 16 Spondylolisthesis 17 Spinal Stenosis 18Treatments 19 Surgical Treatments 21 Fusion Techniques 22 ALIF 23 PLIF 24 TLIF 25 Lateral Approach 26AxiaLIF® 27 A Different Approach to Fusion 32 AxiaLIF Step-by-Step ® 30 AxiaLIF Patient Testimonials ® 33 What to Expect from the Procedure 34Glossary of Terms 36
  • 6 7 The human spine is a well-protected structure of bones and joints surrounded by muscles and supporting soft-tissues. We often only come to learn about its unique structure at the time we may be experiencing a problem, such as leg or back pain. In order to understand the source of (7) your pain, it is important to understand the Cervical Vertebrae structure of the healthy spine. The spine consists of 33 bones and is divided into 5 main areas: (12) Thoracic - Cervical Spine (Neck) 7 - Vertebrae Vertebrae - Thoracic Spine (Ribs) 12 - Vertebrae - Lumbar Spine (Lower Back) 5 - Vertebrae (5) Lumbar - Sacral Spine (Pelvis) 5 – Vertebrae Vertebrae (naturally fused) Sacral Spine - Coccyx (Pelvis) 4 – Vertebrae (naturally fused) Coccyx Understanding Your Low Back Your low back, or lumbar spine, bears the majority of the load for the spine. It holds the weight and supports almost every type of movement that your body performs. Because the lumbar spine is under almost constant physical stress its structure may begin to fail over time. This is why the lumbar spine is so commonly the source of back pain. How We Talk About the Spine When doctors talk about the spine they refer to each bone in the spine by a letter and a number. As a patient, this initially may be confusing. To simplify the terms, we will focus on how we identify each vertebra in your lower back.
  • 8 9 L1 L2 Transverse Process Pedicle 5 Lumbar L3 Vertebrae L4 L5 Lamina Spinous ProcessThe Bones in Lumbar Spine The VertebraeThe lumbar spine consists of five numbered The vertebrae bear the majority of weightvertebrae: L1, L2, L3, L4, and L5. The “L” for the spine. The outermost layer of eachrepresents the lumbar spine, and the vertebra consists of hard bone callednumber represents the order in which the cortical bone while the inside of thevertebrae appear. L5 is the closest vertebra vertebra consists of cancellous bone, ato your tailbone, farthest away from your porous bone structure.head. The numbers of the vertebraeget smaller as you move away from the The spinal cord passes through the vertebratailbone. Therefore L1 is the farthest lumbar via a bony ring called the spinal canal. Thevertebra from the tailbone. posterior elements of the spinal cord break into the cauda equina, which is a series of nerves and nerve roots that continuesThe Bones in Sacral Spine through the spinal canal.The bones of the sacral spine are normallyfused together. The five fused vertebrae The spinal canal is made uphowever are still labeled S1 through S5 as if of different parts:they were separate. The S1 vertebra is the • laminaclosest to the lumbar spine. The L5/S1 disc • spinous processspace connects the lumbar and sacral spineand is a common source of low back pain. • transverse processes • pedicle
  • 10 11 Nucleus Pulposus Intervertebral Discs Nerve Roots Annulus Spinal CordIntervertebral Discs The Spinal Cord and Nerve RootsBetween each vertebrae in the spine is The spinal cord passes through eacha disc that, when healthy, functions as vertebra via the spinal canal. When healthy,a natural shock absorber between the the vertebral structure helps protect thevertebra and helps maintain proper disc spinal cord and the sensitive nerves thatheight. The intervertebral disc is made up extend from it. Most low back pain andof two different parts: leg pain associated with spine conditions• Annulus – a strong, outer ring of fibers originates from pressure that is placed on that helps keep the vertebra intact these nerve roots when the bones in the spine become misaligned or move too• Nucleus – a soft, jelly-like center closely together. consisting mostly of water that helps absorb pressure
  • 12 Conditions Facet Joint Contributing T Low o Back PainFacet JointsFacet joints act as connectors for thevertebrae in your spine and are involved inthe overall motion of the spine.There is one facet joint on each side of avertebra. Known as synovial joints, thesejoints allow the movement between twobones. Ligaments and soft tissue surroundthe facet joints and hold synovial fluidwhich “grease” the joints to decreasefriction as they rub together.
  • 14 15 Painful conditions of the spine may be difficult to understand because often the pain is felt elsewhere, such as in your legs or buttocks. This pain is caused by pressure placed upon the nerves that pass through your spine and extend through the rest of your body. We’ve seen how the healthy spine works to protect its own structure, including Stenosis the spinal cord and the nerves that pass through it. We’ll now focus on some conditions that can compromise the normal structure of the spine resulting in nerve Spondylolisthesis compression and pain. • Degenerative Disc Disease • Spondylolisthesis • Stenosis Degenerative Disc Disease
  • 16 17 Bone Spurs Degenerative Forward Slip Disc Disease at L5-S1 Vertebral BodiesDegenerative Disc Disease (DDD) SpondylolisthesisDegenerative disc disease is not truly a Spondylolisthesis occurs when one vertebradisease. It’s a term used to describe the slips forward in relation to an adjacentgradual deterioration of intervertebral discs vertebra. The symptoms that accompanythat may occur naturally with the aging spondylolisthesis include pain in the lowprocess or as result of injury. back, thighs and/or legs, muscle spasms, • Loss of hydration in the disc can shrink weakness, and/or tight hamstring muscles. the disc and compromise its ability to • Degree of slippage classified in grades, act as a shock absorber between each Grade 1 being the least amount, Grade vertebra IV the most • Loss of disc height can place pressure • Many people affected experience on the nerve roots causing pain in the no pain or symptoms buttocks and legs • May result from improper lifting of • Ruptured discs can bulge and put heavy items, weightlifting, or high pressure on nerves causing leg and impact sports, such as football or back pain gymnasticsCommon Symptoms Common Symptoms • Low back pain • Low back pain • Pain in legs and/or buttocks • Lordosis (swayback) • Pain may increase while sitting or • Pain and/or weakness in legs standing for extended time • Tightness in the hamstrings • Pain may decrease while walking, (muscles at back of thigh) or laying down • Symptoms grow worse with exercise
  • 18 Treatments Spinal Stenosis Bone SpursSpinal StenosisSpinal stenosis is the narrowing of thecanal that surrounds the spinal cord.The narrowing can be caused by theenlargement of joints, arthritis, bone spursor the calcification of ligaments in thespine. As the canal narrows, pressure maybe placed on nerves causing pain and/ornumbness felt in the back and legs. • A degenerative condition that is most common in older adults • Years of wear-and-tear contribute to the condition • It is possible to be born with spinal stenosisCommon Symptoms • Low back pain • Weakness, tingling, numbness or pain in legs • Standing or walking brings on symptoms • Rest may reduce symptoms • Leaning forward often relieves symptoms
  • 20 21 There are various methods of treating low-back pain including both non-surgical, and surgical techniques. Your doctor will work closely with you to isolate the source of your low-back pain and recommend the course of treatment that is most appropriate for you. In most cases, a non-surgical treatment will be recommended. Treatments can range from exercise and behavior modification, to medications that reduce pain or swelling, or epidural injections. While some patients may improve with non-surgical treatments, others may try several treatments without success. In such cases, doctors may recommend a surgical treatment. Surgical Treatments To alleviate low-back pain there are surgical processes, called spine fusion, that help restore disc height, and immobilize vertebrae to stop motion at painful joints and reduce any unnatural pressure on the neighboring nerve roots. These treatments utilize surgical implants and natural bone graft material that is placed between two vertebrae after the surgical removal of the damaged intervertebral disc material. In healing, the graft material grows in the disc space, joining the two vertebrae together effectively eliminating the painful motion.
  • 22 23Fusion TechniquesThere are several surgical techniquesavailable for spine fusion. Traditionaltechniques approach the spine directlythrough open incisions, while newer,minimally invasive techniques approach thespine through small incisions. If you requirespine fusion, the fusion techniques selectedmay depend on the treatment required foryour particular case, individual anatomy, oron the preferences of your surgeon. ALIFTraditional Fusion The ALIF procedure takes an anterior (from • ALIF the front) approach to the spine through (Anterior Lumbar Interbody Fusion) an incision in the abdomen. The procedure • PLIF is often performed by two surgeons. One (Posterior Lumbar Interbody Fusion) general/vascular surgeon may provide • TLIF access to the spine through the abdomen (Transforaminal Lumbar Interbody Fusion) and ensure all major vessels are successfully retracted away from the surgical approach.Minimally Invasive Techniques (MIS) The spine surgeon will then proceed to remove all, or a portion of the damaged • Lateral Interbody Fusion disc and replace it with a surgical implant • MIS TLIF and bone graft material. For additional stability, a second posterior(from the back)Least Invasive Techniques procedure may be performed to insert • AxiaLIF® support rods or screws. • AxiaLIF 2L® • Surgical time ranges from 3 to 8 hours • Hospital stay ranges from 3 to 5 days • Typically a 5-inch incision in abdomen • Some risk of muscle and tissue scarring • The procedure does not preserve ligaments and tissues directly supporting the spine • Risks reported in literature of vascular injury, nerve injury, incontinence, impotence, muscle and tissue scarring
  • 24 25PLIF TLIFThe PLIF procedure takes a posterior Like the PLIF procedure, TLIF begins with a(from the back) approach to the lumbar posterior (from the back) incision, howeverspine through an incision in the patient’s the surgical angle approaches the vertebraback. The surgeon must detach and move more laterally, or diagonally toward themuscles attached to the vertebrae, and in patient’s side. The altered approach to thesome cases a portion of vertebral bone spine, compared to PLIF, limits some of thecalled the lamina, may be removed for operative trauma to supporting muscle andbetter visualization and access to the disc soft-tissue.space. To access the disc space, the surgeon may • Surgical times ranges from 3 to 8 hours remove a portion of the lamina (a bone • Hospital stay ranges from 3 to 5 days covering the spinal nerves) and all of the facet joint, which is a major stabilizer of • Typically a 6-inch incision the spine. The access route, though less • Dissection of muscle and soft-tissue of invasive than the PLIF procedure, still the spine can cause post-operative pain involves disruption of muscle, soft-tissue and slow healing process and nerves and it may pose a risk of post- • Risks reported in literature of vascular operative pain and complications. injury, nerve injury, incontinence, • Surgical times range 2 to 4 hours impotence, muscle and tissue scarring • Hospital stay ranges from 3 to 5 days • Typically a 4-inch incision • Risks reported in literature of vascular injury, nerve injury, incontinence, impotence, muscle and tissue scarring
  • 26 27 AxiaLIF ® The Least Invasive Solution to Lumbar FusionLATERAL APPROACHThe lateral approach is a newer techniquethat approaches the spine through a smallincision in the patient’s side. It avoids theneed to cut or remove muscles in thepatient’s back to approach the disc space.The procedure is less traumatic, and canoffer better recovery time than open spineprocedures; however, the procedure iseffective only in treating vertebrae that areeasily accessed from the side. This excludesthe L5/S1 disc space and frequently L4/L5 insome patients. These are two disc spaceswhich are often the source of a patient’sback pain and levels that are frequentlyoperated on. • Less invasive than open spine procedures • Can offer faster patient recovery • Lateral approach unable to access the L5/S1 disc space • Access to L4/L5 disc space may be limited in some patients • Risk of transient numbness and prolonged thigh pain due to nerve retraction during surgery
  • 28 29 AxiaLIF 360® and AxiaLIF®2L™ The AxiaLIF® procedure is the least invasive approach to lumbar fusion. Rather than accessing the spine from the back, through muscle and supporting soft-tissue, or from the front, through the abdominal cavity — AxiaLIF® approaches the spine from below, through a small 1-inch incision next to the tailbone. With this approach, no muscles or blood vessels are retracted or dissected, and the nerve roots at the back of the spine are avoided, thus reducing the potential for complications. Access to the disc space is achieved without compromising the outer supporting structures of this disc, including the annulus and major supporting ligaments. This allows the surgeon to remove the damaged disc from within, without sacrificing the overall disc structure. A strong, titanium rod is used to engage the vertebral bodies above and below the disc space. This allows the surgeon to restore the height of the disc space which can remove pressure from the nerves. The AxiaLIF® procedure is the least invasive approach to L5/S1 fusion and AxiaLIF® 2L™ offers a 2-level fusion with a single one-inch incision.
  • 30 31AxiaLIF Step-by-Step ®Step 1 Step 4Degenerative disc and improper disc height Bone growth material is inserted in placebefore the AxiaLIF ® procedure. of the diseased discStep 2 Step 5Access to the diseased disc is obtained Lost disc height is restored and the spine is stabilizedStep 3Center of the diseased disc is removed
  • 32 33 AxiaLIF®A soft-tissue sparring Patient Testimonialsapproach to fusion • Return to work in as little as 2 weeks unlike open procedures which may require as many as 30 or more days • Not an open procedure - percutaneous approach means the entire procedure is “I feel very fortunate, that I got done through a small tube referred to this physician who was using the TranS1 approach.” • Visually guided under flourscopy – a live x-ray guides the surgeon during the procedure, rather than using a large incision for a direct view • Small 1 inch incisions • Surgical time typically less than 2 hours “All around it’s just a better procedure.” • Hospital stay typically ranges from 1 to 2 days • Posterior fixation can be completed in a single surgical setting • Less likelihood of post-operative complications “It has changed my life . . . immediately.” • No disruption of spine supporting muscles or tissue which allows for faster recovery “After the surgery, I’m driving around in my big truck and I’m crying. I’m crying because I’ve got my life back.”
  • 34 35What to Expect fromthe AxiaLIF Procedure* ®To help you understand what to expect What kind of follow-up can I expect?from the AxiaLIF ® surgery, we have listed Follow-up varies from surgeon to surgeon.the more common questions that patients However, your first follow-up visit willask. If you have further questions, please probably be within a few weeks of surgery,consult your doctor. Your doctor is the then every few months for the first year.best source of information regarding After the first year, you should be checkedyour healthcare. annually.What is the goal of surgery How do I rehabilitate after surgery?of the AxiaLIF ® surgery? Every surgeon follows a slightly differentThe primary goal of surgery is to relieve program. Your doctor will advise youyour pain. This will be acheived by accordingly.stabilizing and fusing the vertebra(e).As with any back surgery, relief of pain will When can I return to work?vary from patient to patient. Typically, AxiaLIF ® patients can return to work in 2 weeks.How long will my surgery last?Surgery time will vary from surgeon to What complications aresurgeon and patient to patient. On average, associated with the procedure?AxiaLIF® surgery will take 1.5 to 2.5 hours. The most serious risk associated with procedure is the risk of bowel perforation.When can I go home from the hospital? Thankfully, this is treatable, non-permanentUsually, a patient can leave the hospital and the occurence has been reported inin one or two days. Typically you can be only 1/2 of 1% of all AxiaLIF ® procedures.released once you have adjusted to oral You may be asked to do a bowel preparationpain medications and you and your doctor prior to surgery to reduce the likelyhood ofare comfortable with your ability to get up any injury.and move about without problems. *Individual results may varyWhen should I start feeling relieffrom my back and/or leg pain?Apart from the pain of surgery, whichmay take days to recover from, youmay feel relief of back and leg painsymptoms almost immediatelypost-operatively.
  • 36 37Glossary of TermsAllograft – obtained from a bone bank, this Cauda Equina – a bundle of nerve rootshuman bone graft material is placed between from the lumbar and sacral spinal nervesvertebrae to develop fusion Cervical Spine – the uppermost portionAnnulus – the outer casing of a vertebral disc of the spine; the neckAnterior Lumbar Interbody Fusion (ALIF) Coccyx – the tailbone– an operation where the lumbar spine isapproached from the front through an incision Contraindication – a factor that rendersin the abdomen the administration of a drug or device or the carrying out of a medical procedureArthritis – inflammation of a joint, usually inadvisableaccompanied by pain, swelling, and changesin structure Cortical Bone – the dense, hard outer layer of bone materialAutograft – a bone graft taken from thepatient’s body that is placed between Degenerative Disc Disease – a slowvertebrae to develop fusion deterioration of discs located between vertebraeAxial Lumbar Interbody Fusion (AxiaLIF ®)the least invasive lumbar fusion technique Disc Degeneration – the deterioration ofwhere the spine is approached through a small a disc and possible loss of disc heightincision near the tailbone Discectomy – removal of a portion of aBone Graft – bone taken from the patient herniated or degenerative intervertebral discduring surgery or a bone substitute that isused to take the place of removed bone or Dura Mater – a protective membraneto fill a bony defect covering the spinal cord and brainBone Spurs – bony projections formed along Facet Joint – There is one facet joint onjoints that can limit motion and can cause pain each side of a vertebra, together these(also called osteophytes) joints allow movement between two vertebrae and provide stabilityCancellous Bone – open, latticed, or porousinner bone structure
  • 38 39Fluoroscope – a portable x-ray machine Minimally Invasive – a surgical procedureused in surgery where a small incision is made and instrumentation is used through this incisionForamen – the small openings in the spinewhich nerve roots pass through Nucleus Pulposus – center of the intervertebral discFusion - the joining together of two ormore vertebra Oswestry Disability Index (ODI) – a low back pain disability questionnaire used to measureHerniated Disc – a bulge in a disc that a patient’s permanent functional disabilitycan press on nerves and cause pain Pedicle – strong portion of the spinalIntervertebral Disc – a flat, round “cushion” vertebral bone that connects the frontthat acts as a shock absorber between of the spine to the back of the spinevertebrae Pelvis – the bony structure formed byKyphosis – abnormal rearward curvature of the hip bones, sacrum, and coccyxthe spine, resulting in protuberance of theupper back (hunchback) Posterior Lumbar Interbody Fusion - (PLIF) – a spine fusion operation whereLamina – a part of the vertebra located the patient’s lumbar spine is approachedin the back of the vertebral body through an incision in the lower backLaminectomy – when part or all of the Radiculopathy – pain originating from alamina is removed pinched, compressed or irritated nerve root that may extend into the extremitiesLordosis – abnormal forward curvatureof the spine in the lumbar region Sacroiliac Joints – joints that connect the sacrum to the pelvisLumbar Spine – lower portion of the spinebetween the thoracic spine and the sacrum. Sacrum – The sacrum consists of fiveThe lumbar spine consists of five bones vertebrae labeled S1-S5. The vertebrae are(vertebrae) labeled L1-L5. normally fused, but in some patients may not all be fused due to natural anatomic variance.
  • 40 41Sciatica – pressure on the sciatic nerve,causing pain which radiates from the backto the lower extremitiesSpinous Process – bony portion oppositethe body of the vertebraSpondylolisthesis – forward displacement ofone of the lumbar vertebrae over the vertebraebelow it Learn more about AxiaLIF ® onlineSpondylolysis – A crack in one or both sides Our informative patient website includesof the facet joint patient testimonial videos, procedure animations and additional resourcesSpinal Stenosis – the narrowing of the spinal to help answer your questions.canal. Often results in compression puttingpressure on the nerve resulting in pain. Please visit www.smallincisionsbigresults.comThoracic Spine – middle portion of the spinebelow the cervical spine (neck) and above thelumbar spine. This area consists of your upperbody and ribs.Transforaminal Lumbar Interbody Fusion -(TLIF) – an operation where the lumbar spineis approached from the sideTransverse Processes – small, bony bumpswhere back muscles attach to vertebrae Related Journal Articles • Perez-Cruet MJ, Khoo LT, Fessler RG: An Anatomic Approach to MinimallyVertebra - (plural: vertebrae) – any one of the Invasive Spine Surgery: “Percutaneous Axial Lumbar Spine Surgery, Surgical Techniques, St Louis: Quality Medical Publishing, Inc., 2006.33 bony segments of the spinal column Copyright © 2006 Quality Medical Publishing, Inc. • Marotta N, Cosar M, Pimenta L, Khoo LT: A Novel Minimally Invasive Presacral Approach and Instrumentation Technique for Anterior L5-S1 Intervertebral Discectomy and Fusion, Neurosurgical Focus, January 2006.Visual Analog Scale - A tool used to help a Copyright © 2006 The American Association of Neurological Surgeons.person rate the intensity of certain sensations • Yuan P, Day T, Albert T, Morrison W, Pimenta L, Cragg A, Weinstein M: Anatomy of the Percutaneous Presacral Space for a Novel Fusion Technique, Journal ofand feelings, such as pain. Spinal Disorders & Techniques, 2006 June; 19 (4):237-241.
  • USA 411 Landmark Drive, Wilmington, NC 28412 Customer Service Tel: 866.256.1206 Fax: 910.332.1701 customerservice@TranS1inc.com Authorized European Representative Medpass International Limited, Windsor House, Barnett Way Barnwood, Gloucester GL4 3RT, UK Tel/Fax: +44 (0)1 452 619 2227 www.TranS1.com © Copyright TranS1® 2004-2008. All Rights Reserved.This product and its implantation are covered by one or more of the following U.S. and EP Patents:U.S. 6,575,979; U.S. 7,087,058; U.S. 6,558,386; U.S. 6,740,090; U.S. 6,790,210; U.S. 6,558,390; U.S. 7,014,633; U.S. 6,899,716; U.S. 6,921,403; U.S. 7,309,338; EP 1257217 and EP 1578315 Additional U.S. and International Patents applied for. 45-0038 Rev. E 9-10-08