MIAMI. (Ivanhoe Newswire) — For the first time in ten years, people with chronic back pain now have a new option to get them back on their feet. The FDA recently approved the newest generation of artificial lumbar discs and some patients who’ve gotten the implants say the results are life-changing.
When you see Jorge Padron working out, it’s hard to believe he ever had a back problem.
Padron told Ivanhoe, “When I would walk even a little hard, the pain was just unbearable.”
He had a deteriorated disc. Doctors wanted to fuse his spine, which would have caused stiffness and a lack of mobility.
“I just thought to myself there’s got to be a better solution than fusion,” said Padron.
He went to see Rolando Garcia, MD, an orthopedic spine surgeon at Orthopedic Care Center in Miami, Florida. Dr. Garcia developed the ACTIV-L artificial lumbar disc. The implant is made of chromium endplates that attach to the patient’s vertebrae. The disc is the first to also use polyethylene, or plastic plates, to allow for a better fit.
“We’re talking about a new generation implant that tries to better mimic or reproduce the movement of the spine when it’s normal,” explained Dr. Garcia.
Good candidates for transplant are people with back pain that’s lasted at least several months that does not respond to non-surgical treatment and those who don’t have osteoporosis.
“Generally speaking, the recovery period for this replacement is faster than with traditional fusion,” Dr. Garcia told Ivanhoe.
Most artificial lumbar disc patients spend just one night in the hospital and are fully recovered after six weeks.
“No pain, full range of motion, running, jumping, hand standing, lifting like nothing ever happened,” said Padron.
Dr. Garcia said surgeons place the insert through the front of the spine, and not the back, sparing muscles from being cut and also easing recovery.
Contributors to this news report include: Cyndy McGrath, Supervising Producer; Robbi Peele, Field Producer; Milvionne Chery, Assistant Producer; Tony D’Astoli, Editor; Andrew Smith, Videographer.
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MEDICAL BREAKTHROUGHS
RESEARCH SUMMARY
TOPIC: Newest Lumbar Disc Replacement
REPORT: MB #4131
BACKGROUND: It is estimated that 70 to 80 percent of people will experience low back pain at some point in their lives. There are many causes of back pain such as injuries and accidents, mechanical problems such as disk breakdown, spasms, tense muscles, and ruptured disks. Back pain may also occur due to some conditions and diseases like scoliosis, arthritis, spinal stenosis, pregnancy, kidney stones, and infections. When you experience numbness or tingling, severe pain that does not improve, or pain after a fall or injury, a doctor should be seen. Acute pain starts quickly and lasts less than 6 weeks, whereas chronic pain lasts for more than three months. Acute pain usually gets better without any treatment besides over the counter medications to ease pain. For chronic pain, more treatment options are available.
(Source: http://www.niams.nih.gov/health_info/back_pain/back_pain_ff.asp)
TREATMENT: Lumbar fusion surgery is the standard treatment for low back pain patients. However, the results of the surgery vary on an individual basis. Some doctors believe that the variation in pain reduction following surgery is because the fusion prevents normal motion of the spine. Artificial disk replacement surgery is an alternative treatment option for low back pain. Artificial disk replacement has been available in Europe for over a decade, while the procedure gained FDA approval for use in the U.S. in 2004. Similar to hip or knee joint replacements, a disk replacement substitutes a mechanical device for an intervertebral disk in the spine. The device restores motion to the spine. Good candidates for disk replacement have back pain caused mostly from one or two intervertebral disks in the spine, no facet joint disease or bony compression on nerves, is not excessively overweight, and has no deformity like scoliosis. The procedure is performed through an incision in the abdomen, allowing the surgeon to access the spine without moving the nerves. There are a number of different disk designs, some of which are still in the experimental stages.
(http://orthoinfo.aaos.org/topic.cfm?topic=a00502)
NEW TECHNOLOGY: The activL Artificial Disc is a lumbar disc replacement device developed by Rolando Garcia, M.D. The artificial disc consists of two endplates made of a mix of metals commonly used in spine surgery and a plastic insert that fits between the two endplates which is designed to move during daily activities. It is designed to allow motion at the treated level of the spine, with a plastic insert which can move from back to front, but not side to side. The design of the device aims to allow motion of the lower back, unlike the results of lumbar fusion surgery, to allow patients to return to their normal lives.
(Source: http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120024d.pdf)
FOR MORE INFORMATION ON THIS REPORT, PLEASE CONTACT:
Joanna Palmer
305-674-2589
If this story or any other Ivanhoe story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Marjorie Bekaert Thomas at mthomas@ivanhoe.com
