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Study: Minimally Invasive Spine Stabilization Safe, Effective Alternative to Spine Fusion in Patients Under 65

Las Vegas, NV—March 14, 2019

Spinal stenosis patients who opted for surgery did just as well with a less invasive procedure using an interlaminar implant to stabilize the spine as patients who had a spinal fusion, according to a study at Hospital for Special Surgery (HSS) in New York City. 

The research, titled, "Interlaminar Stabilization Surgery vs. Posterior Lumbar Fusion Surgery: Five-Year Follow Up in the ≤ 65 Year-Old Patient," was presented today at the American Academy of Orthopaedic Surgeons Annual Meeting in Las Vegas. 

Lumbar spinal stenosis occurs when the space around the spinal cord narrows, putting pressure on the nerves traveling through the lower back into the legs. When pain is severe and ongoing, and conservative treatments fail to provide relief, patients often consider surgery. 

“Many common conditions of the spine can result in lumbar spinal stenosis, such as a herniated disc, spondylolisthesis, or degenerative joint disease (osteoarthritis),” explains Antonio Brecevich, MD, a research fellow in the Spine Service at Hospital for Special Surgery who presented the study. "A procedure called 'decompression surgery' is performed to remove a portion of a bone, damaged disc or ligament that is putting pressure on the nerves and causing pain."

Decompression surgery is widely considered the standard treatment for lumbar spinal stenosis, and it may be performed with another procedure, such as spinal fusion, to stabilize the spine, says Frank P. Cammisa Jr., MD, chief emeritus of the Spine Service at HSS and senior investigator. "Recent trends indicate that spine fusion surgery has disproportionately increased, despite being the more expensive and invasive approach," he noted. "Serving as an intermediate option to decompression alone and decompression with spinal fusion, our study looked at interlaminar stabilization as a less invasive, non-fusion surgical treatment option that could provide stability and also preserve motion in the spine." 

"Degenerative spinal stenosis is most commonly seen in older patients and there aren’t many studies on treatment options available to the younger and more active patient population under age 65," said Dr. Brecevich. "Spine surgeons are seeing increasing numbers of younger patients with the condition, and the goal of our study was to see how they fared."

HSS investigators set out to compare the five-year outcomes of decompression surgery plus interlaminar stabilization (D+ILS) to decompression plus posterior lumbar fusion (D+PLF) in patients 65 and younger. They collected data from the original randomized controlled Investigational Device Exemption clinical trial for the Coflex Interlaminar Stabilization Device, which included 322 patients from 21 sites in the United States enrolled between 2006 and 2008. 

The HSS study included 181 patients from the clinical trial, with 131 in the D+ILS group and 50 in the D+PLF group. The mean age in both groups was 56 years old. Data analysis revealed that patients in the spine stabilization group had a shorter hospital stay compared to patients in the spine fusion group (1.79 days versus 3.06 days). Significantly less time was needed to perform the surgery in the spine stabilization group (96.5 minutes versus 153.3 minutes in the spine fusion group). Device-related complications in the first 24 months following surgery affected less than one percent (0.8 percent) of spine stabilization patients versus six percent of spine fusion patients.   

At five-year follow-up, no statistically significant difference in patient-reported outcomes was found between the two groups in terms of pain relief, function or patient satisfaction. 

"Decompression surgery with interlaminar stabilization has been shown to be a durable, safe and effective treatment option for the younger spinal stenosis patient with or without low grade spondylolisthesis," the researchers concluded. "It is significantly less invasive for the patient, as measured by shorter operative times, decreased blood loss, and shorter lengths of hospital stay, with fewer device-related complications. In this younger and more physically active patient population, we believe this safe and efficacious surgery should be considered before more invasive fusion surgery."

The researchers also noted that the escalation of hospital costs is a growing concern and that interlaminar spine stabilization is a much more cost-effective option. 

 

 

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