Texas Back Institute (TBI), located on the campus of Presbyterian Hospital of Plano, led the way in the FDA study, becoming the first center in the United States to perform the artificial disc surgery in March 2000. TBI was one of 15 clinical sites in the national investigational study. Surgeons at TBI performed 80 of the 304 cases (25 percent) of the randomized portion of the U.S. study.

"Texas Back Institute has been closely following the development and progress of CHARITÉ in Europe for the last 15 years and keenly watching the clinical development of this new technology. We were pleased to help bring this medical advancement to patients in the United States," said Stephen H. Hochschuler, M.D., spine surgeon, co-investigator of the CHARITÉ disc and co-founder of TBI in Plano.

While artificial replacements are commonly used in hips and knees, this is the first FDA approval of such a device for spinal discs. "This is a significant breakthrough that has the potential to revolutionize spine surgery. Until now spine surgery relieved pain by fusing discs, limiting motion. Now, for the first time, we can relieve pain and preserve motion," said Scott Blumenthal, M.D., principal investigator in the CHARITÉ Artificial Disc clinical trial and president of TBI.

Richard Guyer, M.D., spine surgeon, co-founder of TBI and co-investigator on the study said, "The CHARITÉ Artificial Disc is a high-tech device made of two metallic endplates and a movable high-density plastic center that, once implanted, is designed to perform and move like the body’s own spinal disc. Spinal discs help maintain the position of the spine and allow for the flexibility to bend and twist."

Lumbar spinal fusion surgery, the most common surgical treatment for low back pain or degenerative disc disease, is effective in reducing pain, but may significantly limit range of motion and put extra stress on discs above and below the fusion site. In spinal fusion surgery a damaged spinal disc is removed, and vertebrae are joined together using bone grafts and metal screws so that motion can no longer occur in this area of the spine. Patients usually have to wear a brace for about three months after surgery. More than 200,000 fusion procedures are performed each year in the United States.

In clinical trials comparing artificial disc replacement to spinal fusion surgery, CHARITÉ Artificial Disc patients maintained or improved their range of motion, experienced pain relief sooner, had a quicker recovery and were more satisfied with the procedure. There were no significant differences in complications.

Typically, two surgeons work together in the artificial disc operation. A general surgeon approaches the spine through an incision in the abdomen and carefully moves blood vessels and internal organs out of the way to provide access to the spine. A spine surgeon then uses special tools to remove the damaged disc and creates a space between two vertebrae for the implantation of the artificial disc. The procedure generally takes about 60 to 90 minutes.

Four years since receiving the nation’s first CHARITÉ disc at TBI, Kyle Spooner, 36, of Fort Worth, Texas, is still going strong. Spooner, father of three, information systems manager and avid golfer, was delighted to receive the CHARITÉ disc because it allowed him to return to work sooner and get back to enjoying an active life.

DePuy Spine, maker of the CHARITÉ disc, will support TBI with the first-ever Spine Arthroplasty Fellowship. According to Earl R. Fender, worldwide president of DePuy Spine, the decision was made "because of the prestige and leadership of TBI’s facility and surgeons during the investigational work on the CHARITÉ Artificial Disc."

Presbyterian Hospital of Plano President Philip Wentworth added, "The team of investigators at TBI are to be congratulated. Presbyterian Hospital of Plano is excited that patients from all over the United States will benefit from this device being approved."

Artificial disc replacement is not for everyone. As with any surgery, there are possible complications that can occur including unresolved pain, allergic reactions, bladder problems and/or infection. If you feel that you might be a candidate for artificial disc replacement, call Texas Back Institute at 1-800-247-BACK to make an appointment with a physician. For more information about the CHARITÉ Artificial Disc, TBI or Presbyterian Hospital of Plano visit www.charitedisc.com, www.texasback.com or www.phscare.org.

Texas Back Institute, Plano, TX

Texas Back Institute (TBI) is the largest freestanding spine specialty clinic and in the United States. The Institute, based in Plano, Texas, was established more than 25 years ago and provides comprehensive medical care for individuals with back and neck pain. TBI is a back care leader specializing in spinal arthroplasty and minimally invasive spine surgery. As an academic health care organization, TBI has trained hundreds of physicians, scientists and allied health professionals. Its research institution employs state-of-the art technology and research to treat patients and is involved in the most clinical trials of artificial discs. TBI's professional staff includes board-certified spine surgeons, general surgeons, internists, chiropractors, physiatrists, pain specialists, exercise physiologists and a team of physical and occupational therapists. Texas Back Institute's main office is located on the campus of Presbyterian Hospital of Plano, with offices in Denton, Fort Worth, Garland, Greenville, Hurst, Midland, TX and Phoenix, AZ. For more information visit www.texasback.com.

Presbyterian Hospital of Plano

Opened in 1991, Presbyterian Hospital of Plano (PHP) is Collin County's only not-for-profit hosptial. A member of Texas Health Resources, PHP is licensed for 231 beds and provides the following services: cardiovascular; orthopedics and sports medicine; rehabilitation; adult critical care and neonatal intensive care; high risk and routine obstetrics and gynecology; medical/surgical; and more. For more information, please call Public Relations at 972/981-8180 or e-mail lesliebaker@texashealth.org

DePuy Spine

DePuy Spine, a Johnson & Johnson company, has worked and partnered with leading clinicians, researchers, and thought leaders to develop products to treat spine disorders for over 20 years. Today, DePuy Spine stands in the forefront of the worldwide spine market, with a substantial sales organization in the U.S. and an expanding worldwide distribution network. The company is committed to advancing the knowledge of all health care professionals and their patients in addressing spinal pathologies

© 2005 HealthNewsDigest.com