The results of a two-year study demonstrate decompression with coflex interlaminar stabilisation extends the durability and sustainability of a decompression procedure. coflex is the first and only motion-preserving, minimally-invasive treatment approved for moderate to severe spinal stenosis post-decompression.
The European study of coflex and decompression alone (ESCADA) two-year trial results were published electronically before print, in January 2018, in the Journal of Neurosurgery Spine, the official journal of the American Association of Neurological Surgeons. ESCADA reports a prospective, randomised, controlled, multi-centre trial comparing decompression alone to decompression with coflex interlaminar stabilisation for the treatment of moderate to severe lumbar spinal stenosis.
A total of 225 patients, across seven European sites, were enrolled in the study with 91% follow up at two years. The study authors concluded that decompression with coflex extends the durability and sustainability of a decompression procedure, as compared to decompression alone.
Patients who received decompression alone experienced significantly more loss of foraminal and posterior disc height compared to the coflex group (p<0.001). Additionally, coflex patients experienced 2.4 times more improvement in walking distance measurements compared to decompression alone patients (p=0.062).
Paradigm Spine, the manufacturer of the coflex device, are specialists in providing motion preservation solutions for the treatment of lumbar spinal stenosis.
Marc Viscogliosi, President and CEO of Paradigm Spine, comments: “these data strongly validate for the surgical spine community that coflex is a safe and effective protector of a decompression procedure.”
“This means that surgeons treating patients with lumbar spinal stenosis can be more confident than ever in their treatment options, knowing that a randomised controlled trial has demonstrated with statistical significance that nearly twice as many patients with decompression alone have a risk of secondary intervention as compared to coflex patients.”
“coflex is the first and only lumbar spinal device that has produced the highest level of evidence in two separate prospective, randomised, controlled studies against two different control groups – which exhibits the thoroughness and reproducibility of these findings. There is now potentially a more effective surgical option between the two typical treatments for lumbar spinal stenosis, and we are proud to lead the way in changing the standard of care for surgeons and their patients with this diagnosis.”
In terms of post-surgery results, at 24 months, the decompression alone group was 1.4 times more likely to be taking opioids compared to the coflex group, and the study found that there were 228% more subsequent epidural steroid injections in the decompression alone compared to the coflex group (p=0.0065).
Speaking of the repercussions of this result, Viscogliosi elaborates: “While the decompression does well, there is an element of compensatory pain management that occurs post-decompression, whether its epidurals or narcotics, and coflex outperforms decompression statistically in epidurals, and at every time point had a lower rate of narcotic utilisation, on that compensatory pain management scale.”
“So the results are quite meaningful. We were surprised to see such a significant difference, and we think that that’s great for patients, that they’ll now have that opportunity to evaluate that based on level one data.”
Michael Rauschmann (Department of Spinal Disorders, Orthopaedic University Clinic of Friedrichsheim, Frankfurt, Germany), ESCADA author and principal investigator, comments, “With the important work of the ESCADA trial, we can see that coflex extends the success and durability of a decompression procedure for lumbar spinal stenosis, while still allowing natural motion to occur.”
“The US IDE study first investigated and defined the long-term problems with lumbar fusion procedures that can be alleviated with coflex. And now, through this controlled trial, we can begin to answer the questions of the sustainability of decompression alone, and the need to provide additional stabilisation with coflex at first surgical intervention to avoid future complications.”
Lumbar spinal stenosis, affecting 1.6 million patients annually in the United States, is the narrowing of spaces in the lower spine, compressing the spinal cord and typically causing pain and numbness in the legs and buttocks. People with spinal stenosis may have difficulty with walking and standing up for long time periods. Most cases of spinal stenosis occur in people aged over 60, due to the degenerative effects of aging.
Decompression surgery is currently the standard surgical practice for treating lumbar spinal stenosis. Viscogliosi explains that coflex is designed to complement this procedure, not replace it: “decompression surgery is a wonderful operation. All we have ever asked coflex to do is extend the durability and sustainability of an already great procedure.”
“Decompression does have some shortcomings, one of which is that the decompression can develop micro-instability, and you don’t get full back pain or leg pain relief. Decompression surgery can be augmented with coflex, as coflex, with its intralaminal placement offloading the facets, can stabilise the spine after the procedure, thereby reducing pain and improving function.”
Overall trial success was based on a combined outcome measure called composite clinical success, in which all four components must be met: Oswestry Disability Index success with an improvement of more than 15 points; survivorship with no secondary surgical interventions or lumbar injections; neurologic maintenance or improvement without worsening; and no procedure or device-related severe adverse events.
This is the same success criteria that was used in the US IDE study of coflex that has published five-year follow-up, allowing some direct comparisons to be drawn between the cohorts representing 547 patients collectively. Secondary measures were also collected such as walking distance, foraminal and disc height maintenance, leg and back pain scores, and opioid use. The rate of patients achieving composite clinical success was statistically superior in the coflex group vs. the decompression alone group (p=0.017).
Viscogliosi comments, “composite clinical success is a very nice way of combining multiple safety and efficacy end points to develop a comprehensive picture of what a therapeutic success would look like. As opposed to looking at any one individual outcome, we are trying to look at the composite picture of a patient’s success. The nice thing about composite clinical success, [is] it has been validated in multiple level one clinical studies conducted in the spine industry, particularly in the United States.”
Further detailing how coflex works, Viscogliosi speaks to Spinal News International: “it does two things. It provides interlaminar stabilisation, and it maintains motion.”
“The interlaminar stabilisation is a function of the anatomical placement of the device, which is approximating the dura, at the level of the facets. When it is placed that deeply in the intralamina space between two contiguous lamina, it really helps to offload the facet, and most of the loading in the posterior part of the spine passes through the lamina bone, and through the facets where the device is the stiffest.”
“The distal arms of the device provide compression and extension, so it allows that maintenance of motion and maintenance of the physiological kinematics of motion.”
The coflex interlaminar stabilisation device has been used in over 60 countries worldwide, and has been implanted over 163,000 times globally.