Artificial Disc Replacement
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Artificial Disc Replacement
Artificial disc replacement (ADR), or total disc replacement (TDR), is a type of arthroplasty. It is a surgical procedure in which degenerated intervertebral discs in the spinal column are replaced with artificial disc implants in the lumbar (lower) or cervical (upper) spine. The procedure is used to treat chronic, severe low back pain and cervical pain resulting from degenerative disc disease. Disc replacement is also an alternative intervention for symptomatic disc herniation with associated arm and hand, or leg symptoms (radicular pain). Artificial (or total) disc replacement has been developed as an alternative to spinal fusion, with the goal of pain reduction or elimination, while still allowing motion throughout the spine. Faster recoveries after surgery have also been widely reported by surgeons. Another possible benefit is the prevention of premature breakdown in adjacent levels of the spine, a potential risk in fusion surgeries. Recent studies have shown a strong correl ...
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Arthroplasty
Arthroplasty (literally " e-orming of joint") is an orthopedic surgical procedure where the articular surface of a musculoskeletal joint is replaced, remodeled, or realigned by osteotomy or some other procedure. It is an elective procedure that is done to relieve pain and restore function to the joint after damage by arthritis or some other type of trauma. Types For the last 45 years, the most successful and common form of arthroplasty is the surgical replacement of arthritic or destructive or necrotic joint or joint surface with a prosthesis. For example, a hip joint that is affected by osteoarthritis may be replaced entirely (total hip arthroplasty) with a prosthetic hip. This would involve replacing both the acetabulum (hip socket) and the head and neck of the femur. The purpose of this procedure is to relieve pain, to restore range of motion and to improve walking ability, thus leading to the improvement of muscle strength. Other types of arthroplasty * Interposition ...
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Intervertebral Disc
An intervertebral disc (or intervertebral fibrocartilage) lies between adjacent vertebrae in the vertebral column. Each disc forms a fibrocartilaginous joint (a symphysis), to allow slight movement of the vertebrae, to act as a ligament to hold the vertebrae together, and to function as a shock absorber for the spine. Structure Intervertebral discs consist of an outer fibrous ring, the anulus fibrosus disci intervertebralis, which surrounds an inner gel-like center, the nucleus pulposus. The ''anulus fibrosus'' consists of several layers (laminae) of fibrocartilage made up of both type I and type II collagen. Type I is concentrated toward the edge of the ring, where it provides greater strength. The stiff laminae can withstand compressive forces. The fibrous intervertebral disc contains the ''nucleus pulposus'' and this helps to distribute pressure evenly across the disc. This prevents the development of stress concentrations which could cause damage to the underlying vertebrae ...
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Spinal Column
The vertebral column, also known as the backbone or spine, is part of the axial skeleton. The vertebral column is the defining characteristic of a vertebrate in which the notochord (a flexible rod of uniform composition) found in all chordates has been replaced by a segmented series of bone: vertebrae separated by intervertebral discs. Individual vertebrae are named according to their region and position, and can be used as anatomical landmarks in order to guide procedures such as lumbar punctures. The vertebral column houses the spinal canal, a cavity that encloses and protects the spinal cord. There are about 50,000 species of animals that have a vertebral column. The human vertebral column is one of the most-studied examples. Many different diseases in humans can affect the spine, with spina bifida and scoliosis being recognisable examples. The general structure of human vertebrae is fairly typical of that found in mammals, reptiles, and birds. The shape of the vertebra ...
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Low Back Pain
Low back pain (LBP) or lumbago is a common disorder involving the muscles, nerves, and bones of the back, in between the lower edge of the ribs and the lower fold of the buttocks. Pain can vary from a dull constant ache to a sudden sharp feeling. Low back pain may be classified by duration as acute (pain lasting less than 6 weeks), sub-chronic (6 to 12 weeks), or chronic (more than 12 weeks). The condition may be further classified by the underlying cause as either mechanical, non-mechanical, or referred pain. The symptoms of low back pain usually improve within a few weeks from the time they start, with 40–90% of people recovered by six weeks. In most episodes of low back pain, a specific underlying cause is not identified or even looked for, with the pain believed to be due to mechanical problems such as muscle or joint strain. If the pain does not go away with conservative treatment or if it is accompanied by "red flags" such as unexplained weight loss, fever, or signific ...
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Degenerative Disc Disease
Degenerative disc disease (DDD) is a medical condition typically brought on by the normal aging process in which there are anatomic changes and possibly a loss of function of one or more intervertebral discs of the spine. DDD can take place with or without symptoms, but is typically identified once symptoms arise. The root cause is thought to be loss of soluble proteins within the fluid contained in the disc with resultant reduction of the oncotic pressure, which in turn causes loss of fluid volume. Normal downward forces cause the affected disc to lose height, and the distance between vertebrae is reduced. The anulus fibrosus, the tough outer layers of a disc, also weakens. This loss of height causes laxity of the longitudinal ligaments, which may allow anterior, posterior, or lateral shifting of the vertebral bodies, causing facet joint malalignment and arthritis; scoliosis; cervical hyperlordosis; thoracic hyperkyphosis; lumbar hyperlordosis; narrowing of the space available ...
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Radicular Pain
Radicular pain, or radiculitis, is pain "radiated" along the dermatome (sensory distribution) of a nerve due to inflammation or other irritation of the nerve root (radiculopathy) at its connection to the spinal column. A common form of radiculitis is sciatica – radicular pain that radiates along the sciatic nerve from the lower spine to the lower back, gluteal muscles, back of the upper thigh, calf, and foot as often secondary to nerve root irritation from a spinal disc herniation or from osteophytes in the lumbar region of the spine. Friday, 20 January 2017 Radiculitis indicates inflammation of the spinal nerve root, which may lead to pain in that nerve's distribution without weakness as opposed to radiculopathy. When the radiating pain is associated with numbness or weakness, the diagnosis is radiculopathy if the lesion is at the nerve root and myelopathy if at the spinal cord itself. See also * Intervertebral disc * Sciatica * Spinal disc herniation * Arachnoiditis Arach ...
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Spinal Fusion
Spinal fusion, also called spondylodesis or spondylosyndesis, is a neurosurgical or orthopedic surgical technique that joins two or more vertebrae. This procedure can be performed at any level in the spine (cervical, thoracic, or lumbar) and prevents any movement between the fused vertebrae. There are many types of spinal fusion and each technique involves using bone grafting—either from the patient (autograft), donor (allograft), or artificial bone substitutes—to help the bones heal together. Additional hardware (screws, plates, or cages) is often used to hold the bones in place while the graft fuses the two vertebrae together. The placement of hardware can be guided by fluoroscopy, navigation systems, or robotics. Spinal fusion is most commonly performed to relieve the pain and pressure from mechanical pain of the vertebrae or on the spinal cord that results when a disc (cartilage between two vertebrae) wears out (degenerative disc disease). It is also used as a backup ...
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Medtronic
Medtronic plc is an American medical device company. The company's operational and executive headquarters are in Minneapolis, Minnesota, and its legal headquarters are in Ireland due to its acquisition of Irish-based Covidien in 2015. While it primarily operates in the United States, it operates in more than 150 countries and employs over 90,000 people. It develops and manufactures healthcare technologies and therapies. History Medtronic was founded in 1949 in Minneapolis by Earl Bakken and his brother-in-law, Palmer Hermundslie, as a medical equipment repair shop. Bakken invented several medical technology devices that continue to be used around the world today. Through his repair business, Bakken came to know C. Walton Lillehei, a doctor of heart surgery at the University of Minnesota Medical School. The deficiencies of the Artificial cardiac pacemaker, artificial pacemakers of the day were made painfully obvious following a power outage over Halloween in 1957, which affecte ...
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Regulation (EU) 2017/745
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021. The regulation was published on 5 April 2017 and came into force on 25 May 2017. Originally approved medical devices will have a transition time of three years (until 26 May 2021) to meet new requirements. Changes Changes compared to the Medical Device Directive include changes in device classification and device scope, stricter oversight of manufacturers by Notified Bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC) and of the economic operator concept, the requirement of Unique Device Identification marking for devices, EUDAMED registration (see below), UDI requirements, and increased post-market surveillance activities. Scope and classificatio ...
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Discectomy
A discectomy (also called open discectomy, if done through a 1/2 inch or larger skin opening) is the surgical removal of abnormal disc material that presses on a nerve root or the spinal cord. The procedure involves removing a portion of an intervertebral disc, which causes pain, weakness or numbness by stressing the spinal cord or radiating nerves. The traditional open discectomy, or Love's technique, was published by Ross and Love in 1971. Advances have produced visualization improvements to traditional discectomy procedures (e.g. microdiscectomy, an open discectomy using an external microscope typically done through a 1-inch or larger skin opening), or endoscopic discectomy (the scope passes internally and typically done through a 2 mm skin opening or larger, up to 12 mm). In conjunction with the traditional discectomy or microdiscectomy, a laminotomy is often involved to permit access to the intervertebral disc. Laminotomy means a significant amount of typically nor ...
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Jack Zigler
Jack Elliot Zigler (born May 27, 1952 in Brooklyn, New York) is a Board Certified orthopedic surgeon specializing in spine surgery at the Texas Back Institute in Plano, Texas. He is best known for being the first surgeon to perform a ProDisc artificial disc replacement surgery in the United States, on October 3, 2001. Organizations Since joining the Texas Back Institute in 1996, Zigler has been an international guest lecturer on topics in spinal reconstruction, as well as a Principal Investigator for the ProDisc artificial disc replacement system's U.S. Food and Drug Administration (FDA) clinical studies. He is a former Clinical Associate Professor of Orthopaedic Surgery at University of Texas Southwestern Medical Center in Dallas, Texas. He served as President of the American Spinal Injury Association from 2003 to 2005. Role as ProDisc Principal Investigator Zigler's role as Principal Investigator for the ProDisc, Synthes Spine's artificial disc replacement system, was to mon ...
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Hierarchy Of Evidence
A hierarchy of evidence (or levels of evidence) is a heuristic used to rank the relative strength of results obtained from scientific research. There is broad agreement on the relative strength of large-scale, epidemiological studies. More than 80 different hierarchies have been proposed for assessing medical evidence. The design of the study (such as a case report for an individual patient or a blinded randomized controlled trial) and the endpoints measured (such as survival or quality of life) affect the strength of the evidence. In clinical research, the best evidence for treatment efficacy is mainly from meta-analyses of randomized controlled trials (RCTs). Systematic reviews of completed, high-quality randomized controlled trials – such as those published by the Cochrane Collaboration – rank the same as systematic review of completed high-quality observational studies in regard to the study of side effects. Evidence hierarchies are often applied in evidence-based practic ...
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