Five-year data demonstrate long-term therapeutic effect of Paradigm Spine’s coflex compared to fusion


The International Journal of Spine Surgery has published five-year long-term, level 1 data on the effects of Paradigm Spine’s coflex, as compared to fusion surgery.

These data demonstrate the long-term sustained therapeutic effect of coflex interlaminar stabilisation (“ILS”) for patients with lumbar spinal stenosis, as compared against fusion. With 322 patients enrolled and randomised in this study, and a high follow-up rate of over 90% at five years, the authors—led by Michael Musacchio, Rush Medical Center, Chicago, USA—conclude, “The results of this study with 5-year follow-up support that decompression and ILS is an effective and sustainable treatment option for moderate to severe spinal stenosis, and not an inevitable precursor to fusion. ILS after decompression produces outcomes similar or superior to fusion with pedicle screws. One and two levels yield equally good results compared to fusion. Two level D+ILS procedures had a significantly lower rate of revision than fusion procedures. Reductions in visual analogue scale for back and leg pain were significant and sustainable in both groups.”

Hallett Mathews, chief medical officer of Paradigm Spine says, “Surgeons appreciate the effectiveness of providing stabilisation after decompression for lumbar spinal stenosis. The long-term results discussed in this landmark article provide definitive Level 1 evidence that fusion stabilization should no longer be the only stabilization consideration for spinal stenosis patients. Surgeons have never been able to decompress lumbar spinal stenosis and stabilise, without some sort of fusion procedure. This is a great day for patients providing an earlier return to daily activities with sustainable therapy.”