‘Like getting my life back’: Craig resident undergoes lumbar spine surgery as part of FDA study at Steamboat’s SOSI
Steamboat Pilot & Today
Craig resident Donnie Kendall is no softy when it comes to pain.
Kendall has been a mixed martial arts competitor, a state champion power lifter, a boxer and a martial arts instructor. He has broken bones and had multiple surgeries, and he makes his living driving massive machinery for Colowyo Mine.
But, for the past two to three years, the progressive pain from a ruptured disc pushing on a nerve in his spinal column kept him from maintaining an active lifestyle and enjoying activities with his grandkids.
Doctors recommended that Kendall undergo spinal fusion surgery, but he waited due to the possible negative side effects. He held out enduring the pain because he knew newer spinal technology was on the horizon.
Then, on Oct. 11, he underwent an innovative lumbar spine surgery to receive an artificial joint replacement as part of a U.S. Food and Drug Administration study with Dr. Alex Sielatycki at Steamboat Orthopaedic & Spine Institute.
“I’m actually really blown away about it,” said Kendall, age 50. “It’s truly amazing that there is something there now that can help. It’s honestly like getting my life back.”
Kendall was the first patient of a planned 20 people to undergo the procedure in Steamboat, and SOSI is the only location in Colorado out of 15 study sites across the country participating in implanting the new device, Sielatycki said. A study control group of fusion procedures is taking place in Denver.
“MOTUS is the world’s first total joint replacement for the lumbar spine, and the only true motion alternative to fusion,” according to device developer 3Spine. “This unique approach replaces all three lower back structures in a single medical procedure while restoring freedom of movement.”
Although artificial spinal discs and facet joints also exist separately, MOTUS, which means motion in Latin, combines both the disc and two facet joints together in one implant device.
Sielatycki, who joined the SOSI team in March, is a fellowship-trained orthopedic spine surgeon who performed three of the new procedures in October in Steamboat including for a Steamboat man in his 40s and a Craig man in his 70s. Another five patients already are scheduled for surgery, but interested patients can apply for study consideration through the end of this year. Most of the patients suffer from degenerative wear and tear on their spine.
The total joint replacement delivers the same benefits as traditional spinal fusion surgeries but also preserves adjacent spinal levels, restores natural balance, maintains range of motion and relieves leg and back pain.
Traditional spinal fusion surgery is not a great solution for many patients, the 37-year-old surgeon said, because 75 to 80% of patients do not receive complete relief. In addition, five years after a fusion procedure, 20 to 25% of patients may require another fusion and 40 to 50% after 10 years.
“This motion-preserving lumbar joint replacement is truly the first of its kind and has the potential to dramatically change the way spine care is provided not only in this country but throughout the world,” said Sielatycki, who has been involved in pilot surgeries for the device since 2018. “I believe we have an answer to the decades-long problem of lumbar fusion complications that have plagued so many patients.”
The surgeon said an estimated 75 to 80% of potential fusion patients would be eligible for MOTUS. Fusion surgery would still be needed for very complex deformities, spinal trauma, severe scoliosis, spinal tumor or spinal infections, he said.
Sielatycki said the MOTUS device has been in development for about 15 years, and the implant for the study is the fourth-generation design. The surgeon said MOTUS implantation is a challenging lumbar joint reconstruction surgery that takes up to three hours, but patients can go home the same afternoon. Patients are walking the next day, but activities are restricted for three months.
“It’s challenging more for the surgeon because it’s a total shift in how we think about the lumbar spine,” Sielatycki said. “There are a lot of variables the surgeons have to think about that we don’t have to think about doing fusion surgery.”
The national study should be complete by early 2023, and since the FDA needs two years of results, approval of the device is anticipated in 2025.
“From biomechanical testing with simulated wear, the device is still holding up. So, in theory it should last a lifetime once implanted.” Sielatycki said. “All of the data to this point is excellent.”
Kendall is still healing, but he is free from the constant pain and is walking a mile a day two weeks out from surgery. He is looking forward to spending more active outdoor time with his five grandchildren, who range from 4 to 8 years old.
“The first thing I want to do is pick up my grandkids again,” Kendall said.
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