To treat early-onset scoliosis, doctors rely on two basic therapies. Moderate spinal curvatures can often be controlled through the use of plaster casts or braces. More severe curves require surgical implants and, in many cases, years of invasive procedures.
A new medical device, the Magec System, hopes to change all that, but early results on the implant’s safety have worried many parents. To learn more, contact our experienced attorneys for a free consultation.
While children with severe scoliosis have a limited range of treatment options, we believe those options should be as safe as possible.
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When a child is diagnosed with early-onset scoliosis, doctors have essentially three choices. One option, obviously the least-invasive, is to simply observe the child for signs of progression. This sort of watching-and-waiting is typical in cases of minor curves. More radical therapies can be attempted if the spinal curvature worsens, or appears likely to worsen. In the case of moderate curvatures, bracing may be enough to straighten the spine without a surgical procedure. Severe curves generally require surgical intervention.
When Is Scoliosis Treatment Necessary?
Spinal curvature is graded according to the Cobb angle, a measure that represents the extent to which a patient’s spine deviates from a straight line. Most researchers, including the experts at the Scoliosis Research Society, agree that Cobb angles over 35 degrees are likely to progress if left untreated. In general, the larger a curve is to begin with the more likely it is to get worse.
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Curve progression comes with a host of potential complications. Alongside discomfort, more-severe curvatures put strain on the vertebrae, the series of interlocking bones that make up the spine. As the curve worsens, these bones can grind together during normal activity, resulting in nerve damage and chronic pain. When a young child is diagnosed with a severe spinal curvature, however, finding the appropriate treatment becomes even more important.
Early-onset scoliosis is diagnosed in children under the age of 10 who are found to have Cobb angles greater than 10°, according to the orthopedic surgeons at Children’s Hospital Los Angeles. The goal of treatment, when no specific cause can be found, is usually to correct the curve as much as possible before the child reaches any major adolescent growth spurts, which could worsen the curvature substantially and lead to life-long complications.
Risks Of Untreated Early-Onset Scoliosis
Children only reach skeletal maturity during their teen years, the Encyclopedia of Children’s Health reports. In other words, kids under the age of 10 have a lot of growing to do, both generally and in terms of their spine. As we’ve seen, severe curvatures of the spine are likely to increase. That’s especially true in younger children, whose spines are also “young.”
The problem of early-onset scoliosis becomes even more acute when we consider that a child’s lungs and heart also have a lot of growing to do. As these organs continue to develop, becoming larger over time, they all have to share the same space. The spine is no exception, but severe curvatures make the growing process difficult for nearby organs. If the curve becomes more extreme, it can crowd out other vital organs, most notably the lungs.
A common symptom of severe progressive scoliosis is difficulty breathing, since the spinal curvature can come to impact lung development and functioning. The medical term for this condition is Thoracic Insufficiency Syndrome, or TIS, the Children’s Hospital of Philadelphia reports. Over time, the supply of oxygen reaching the heart can be compromised, which is why serious heart conditions are noted as a long-term complication of untreated early-onset scoliosis.
Bracing For Minor To Moderate Curves
Moderate spinal curvatures can often be treated primarily through the use of plaster casts or braces. According to Spine-Health.com, bracing is generally recommended for curvatures in young children between 10° and 25° by Cobb angle.
The goal of bracing isn’t to correct the spinal curve. Curvatures, in almost all cases, won’t become straighter unless surgical intervention is performed. Rather, bracing is applied to limit the progression of a pre-existing curve. In other words, braces keep minor to moderate curves under control, so the condition doesn’t worsen throughout a patient’s adult life. And the hope, for young children, is to reduce the need for a future surgery, by keeping the spinal curvature below at least 40° before they’ve reached skeletal maturity.
Surgical Treatments For Severe Cases
To correct a severe spinal curvature, however, orthopedic physicians have little choice but to operate. In a 2012 review of the medical literature for Current Reviews of Musculoskeletal Medicine, doctors at Emory University describe the two main procedures used to treat early-onset scoliosis, both of which involve medical implants:
- Expansion thoracoplasty
- Growing rods
Expansion Thoracoplasty
Expansion thoracoplasty is used specifically to treat cases of Thoracic Insufficiency Syndrome, when the spinal curvature leads to deformities in the thoracic cavity and causes problems in lung development. The surgery is performed using VEPTR, the Vertical Expandable Prosthetic Titanium Rib manufactured by DePuy Synthes.
TIS is an exceedingly-rare condition. As such, VEPTR, the only medical device cleared for the condition’s treatment, was approved by the US Food & Drug Administration as a Humanitarian Use Device. The designation is reserved for devices used to treat medical disorders that affect fewer than 4,000 Americans every year. To use the device in practice, clinicians are required to seek prior approval from their medical facility’s institutional review board.
VEPTR does something that no other spinal implant does, addressing the thoracic (chest-related) complications entailed by severe spinal curvatures. The device is a curved metal rod that, once implanted, helps to separate a child’s ribs and straighten their spine. At routine intervals, the implant will need to be lengthened, to account for the patient’s physical development. This lengthening (or “distraction”) procedure is performed in an invasive, though normally out-patient, operation, Seattle Children’s Hospital says.
Traditional Growing Rod Surgery
The more-common treatment for early-onset scoliosis involves one or two growing rods. The concept behind growing rod treatment is simple. A flexible implant rod is anchored to the spine, normally on both sides. When tightened, the rods straighten out, correcting the spinal curvature at the same time. After surgery, the spine will continue to grow, but it will do so along the straighter path made possible by the growing rods. When the child’s skeleton matures, the growing rods are removed and surgeons will perform a final fusion procedure to hold the vertebrae together in their now-corrected conformation.
Do Growing Rods Work?
Growing rods are highly-effective. In 2005, researchers at the San Diego Center for Spinal Disorders followed 23 patients who had received traditional growing rods. Prior to treatment, the average patient included in the study had a scoliosis curve of 82°. After 8 years of growing rod therapy, the average curve had dropped to 27.7°. The initial implantation procedure alone corrected the patients’ spinal curves by an average of 44°. The growing rod technique “is safe and effective,” the surgeons wrote in their paper for Spine, “maintain[ing] correction obtained at initial surgery while allowing spinal growth to continue.”
Problems & Complications
Traditional growing rods, though, come with what once appeared to be an unavoidable problem. These implants were designed to treat young children, the very same patients in whom spinal growth will continue. So the growing rods must be lengthened (distracted) occasionally to extend along with natural extensions in the spine’s length. In most cases, distraction procedures must be performed at 6-month intervals, according to the Vanderbilt University Medical Center.
Children with severe scoliosis may need to undergo up to 20 surgical operations during the course of their treatment. For obvious reasons, asking a young child to endure up to 20 invasive procedures before they reach the age of 18 is not ideal. Beyond the physical and emotional toll growing rod treatment has on children and their families, the method is not without complications.
A group of Japanese surgeons at Tokyo’s Keio University published the results of their clinical review of 88 growing rod patients in a 2013 edition of Spine. Over an average of 3.9 years, these 88 children underwent a total of 538 surgical operations. Nearly 60% of the patients experienced complications during the study period, 72% of which were considered “implant-related.” The likelihood of a surgical complication increased by 24% every time another procedure was performed.
Can Magec Save Children From Repeat Procedures?
The Magec System was introduced to the US market in 2014 to change these troubling statistics.
A Magec growing rods looks very similar to a traditional implant, but with one major difference. Near one end of the device, you’ll find an actuator, a small compartment that contains a magnet. This magnet can be activated from the outside of a patient’s body, using an external remote control. And once activated, the magnet begins to rotate, lengthening or shortening the rod to specifications keyed in by a doctor on the remote control. In theory, no repeated surgical procedures are required. After the initial implantation, the distraction process can be completed without any pain in a brief in-patient doctor’s visit.
Studies Raise Safety Concerns
Though many hospitals and medical professionals are now touting the Magec System as a revolutionary innovation, it would be premature to endorse the new treatment method as a success. Early reports on the efficacy of Magec growing rods have, to this point, been encouraging, but a growing number of researchers are concerned about the device’s safety.
Over the last 2 years, a number of studies in the medical literature have linked Magec growing rods to a “substantial” rate of premature failure, UK surgeons write in The Bone & Joint Journal. Alongside these reports of implant fracture, physicians have also noted a high rate of metallosis, a medical condition attributed to the metal debris that some implants can release, in Magec patients. To learn more about this research, visit our full guide on Magec growing rods here.