Device company Paradigm Spine has published two separate independent prospective clinical studies that examine the short- and long-term durability of coflex interlaminar stabilization. Here are four things to know about the two studies.
1. The study Role of coflex as an Adjunct to Decompression for Symptomatic Lumber Spinal Stenosis examined decompression alone in comparison to decompression supplemented with coflex interlaminar stabilization. The researchers examined patient reported outcomes and imaging two years after surgery.
2. Researchers reported a statistical improvement in outcomes of the coflex group over the decompression only group. Postoperative imaging studies revealed significant maintenance of disc and foraminal heights with interlaminar stabilization in the coflex group compared to the decompression only group.
3. Paradigm Spine also published the study coflex Dynamic Distraction Stabalization Device for Lumbar Degenerative Diseases. The multicenter prospective study focuses on outcome measures such as back pain improvement, functional stabilization of disc heights and foraminal volume with maintenance of dynamic motion at the index level of surgery. The study found significant improvement in each category.
4. "The improved initial results and durability of the symptom relief at two years is impressive," said Hallett Matthews, MD, MBA, executive vice president and CMO, in the news release. "Simple decompression results without the addition of coflex were not always sustainable over time. Interlaminar stabilization clearly leads to improved patient outcomes and value.
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