According to a study published in The Lancet, new magnetically controlled growing rods can treat the spinal disorder scoliosis in children without the need for repeated invasive surgeries.
The study was conducted by Professor Kenneth Cheung and Dr. Dino Samartzis, from the Department of Orthopedics and Traumatology, The University of Hong Kong, Hong Kong, and colleagues.
Scoliosis is an abnormal curving of the spin that occurs primarily in young children and adolescents. Scoliosis can rapidly progress if left untreated and cause breathing problems, as well as cosmetic disfigurement.
Traditional treatment for children with scoliosis who are still growing is surgical insertion of growing rods under general anesthesia. However, every six months a procedure called distraction is required in order to lengthen the rods.
Not only are these repeated surgeries considerably expensive, but they are associated with various socioeconomic draw backs. For example, children are forced to miss school and parents might miss work in order to support their child.
In this study, the researchers evaluated a new remotely distractible, magnetically-controlled growing rod (MCGR) system that allows frequent non-invasive outpatient distractions.
The team implanted the MCGR in 5 patients, two of whom have currently reached 24 months follow-up. Participants of the study received outpatient distractions on a monthly basis. The researchers used radiography in order to measure the magnitude of the spinal curvature, spinal length and rod distraction length.
In order to evaluate clinical outcomes, the researchers measured the degree of pain, procedure-related complications, mental health, function, as well as satisfaction with treatment.
Before implantation of MCGR, the mean degree of scoliosis in the two participants with 24 months follow-up was 67° and 29° at 24 months.
According to the researchers, each outpatient distraction increased the length of the instrumented segment of the spine by a mean of 1.9 mm and in congruence with their normal growth.
Furthermore, both participants reported no pain, had good functional outcome and were satisfied with the procedure throughout follow-up. No complications related to the procedure were noted.
The researchers said:
"MCGR will eliminate the need for repeated operations under general anesthesia, wound complications, and socioeconomic and health-care costs associated with the procedure.
The preliminary results from the first two patients to undergo the treatment for a minimum of 24 months suggests that this non-invasive outpatient procedure is effective and safe.
Whether MCGR leads to significantly better outcomes than traditional growing rods is not yet know, but early results are positive and the avoidance of open distractions is a great improvement.
Additionally, this new growing rod system has potentially widespread applications in other disorders that could benefit from a non-invasive procedure to correct abnormalities. MCGR could assist with correction of limb abnormalities, thoracic insufficiency syndrome, limb lengthening, limb salvage procedures, or any disorders or injuries in which slow, progressive change to bone structures is needed."
In a joint comment, Dr John T Smith, University of Utah School of Medicine, Salt Lake City, UT, USAm and Dr. Robert M Campbell Junior, The Children's Hospital of Philadelphia, University of Pennsylvania, PA, USA, state that in order to substantiate the results in this study more patients need to be followed up for longer, and that long-term functionality of magnetic rods must be verified.
"Magnetically controlled growing-rod technology is being developed outside the USA, where, in our view, the pathway to develop and test new technology faces excessive barriers (growing rods remain unapproved by the US Food and Drug Administration).
If this technology was available in the USA, we believe that it would be rapidly used to avoid repetitive surgeries and improve quality of life for children with spinal deformity.
We strongly encourage Cheung and colleagues to continue to report their results both positive outcomes and adverse events. We are hopeful that further development of the technology will make this treatment increasingly available to children worldwide."
Written By Grace Rattue