Clinical innovation moves at breakneck speed, and this year saw a number of ‘firsts’ in spine surgery. Here are four that could potentially change the spine industry:
First ever spine surgery with 3D-printed vertebral body
In August, spine surgeons made history when they performed the first spinal disc replacement implanting a 3D printed vertebra. Three-dimensional printing technology uses digital models of a patient’s anatomy to construct a “printed” customized implant in almost any material. The technology isn’t new per se, however applying it to the orthopedic device space is cutting-edge.
The spinal procedure in China using a 3D-printed vertebra replaced the second vertebra in a 12-year-old boy’s neck. After the procedure, the patient’s head was framed with pins and will remain that way for three months. Dr. Liu Zhongjun performed the procedure and said the customized 3D printing technology made the surgery stronger and more convenient than other procedures.
The 3D printing in medical applications market is expected to reach $0.9 billion by 2019, according to a new report from Transparency Market Research. North America held the largest market share for 3D printing in medical applications in 2012, and several device companies are looking to this technology. Medicrea offers 3D-printed UNiD ALIF customized cages, which are part of the company’s entire patient-specific spine implant offerings. In August, Oxford Performance Materials was honored by the New Economy Magazine for developing an additive manufacturing technique with ultra-high performance PEKK to print patient-specific functional and biocompatible prosthetic implants. OPM is the only company with FDA clearance to manufacture 3D polymeric orthopedic implants.
It may be years before spine surgery with 3D printed implants becomes the standard of care, however, it has the potential to change the spine industry as we know it.
First U.S. fetoscopic spina bifida repair successful at Texas Children’s Hospital
The first two-port fetoscopic procedure to repair spina bifida in-utero in the United States was performed this year by surgeons at Texas Children’s Fetal Center and Baylor College of Medicine, both located in Houston. Michael Belfort, MD, obstetrician and gynecologist-in-chief at Texas Children’s Hospital, and William Whitehead, MD, a pediatric neurosurgeon developed the procedure. The team also worked with Dr. Jose Luis Peiro and Dr. Elena Carreras of Vall D’Hebron Hospital in Barcelona, Spain.
The surgery features an in-utero, single layer, suture repair through two different four-millimeter incisions in the uterus. Physicians use a carbon dioxide gas technique during the procedure to repair the spina bifida.
Years of preparation and training went into developing the program both nationally and internationally. Before performing the procedure, Drs. Belfort and Whitehead performed more than 30 simulated procedures using the simulator including two full simulations, gowned and gloved under actual operating room conditions with a full support team.
While the procedure was successful, the final outcome remains to be seen. “While we have had a technical success with this procedure, we will only be able to truly know the outcome once the baby has been delivered and we are able to assess the spina bifida repair,” says Dr. Whitehead.
Spinal cord stimulation results in voluntary movement for paralyzed patients
In April, a study was published in Brain showing that paralyzed spinal cord injury patients may be able to regain voluntary movement in their legs and feet. The study was conducted by researchers from the University of California, Los Angeles and the University of Louisville (Ky.), who implanted spinal-cord stimulators made by Medtronic into the three paralyzed individuals, according to a Wall Street Journal report.
Neuromodulating the spinal circuitry with epidural stimulation combined with physical therapy has resulted in three individuals being able to wiggle their toes, flex their legs and even stand independently for moments at a time. Two of the three individuals had complete paraplegia and previously could not move at all.
Spinal cord stimulation currently does not allow a paralyzed individual to walk again, however, the researchers found that in addition to standing, the therapy does help improve a number of other bodily functions, such as bowel and bladder function, according to a CBS News report.
The research was partially funded by the National Institutes of Health and the Christopher & Dana Reeve Foundation, the CBS report notes.
Stem cell transplant reverses spinal paralysis
An Anglo-Polish team of physicians in Britain pioneered the new technique that has reversed spinal paralysis for the first time. The medical team implanted harvested cells – known as olfactory ensheathing cells, which repair damage to nasal nerves – into an 8mm gap in the spinal cord of Darek Fidyka, a Bulgarian who was confined to a wheelchair after being stabbed in the back in 2010.
Physicians reported that the cell implants on the two “stumps” of the spinal cord slowly restored the nerve fiber connections between both sides, returning feeling and movement to Mr. Fidyka’s legs. Around 10 months after the surgery in 2012, Mr. Fidyka was able to walk with the aid of braces and a walking frame.
The new technique has thus far only been applied to Mr. Fidyka. The medical team and other experts emphasize further testing.
Professor Geoff Raisman, chair of neural regeneration at University College London’s Institute of Neurology, who led the research team in Britain, told BBC News that what had been achieved was “more impressive than man walking on the moon.”