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Similar subjective results seen with decompression alone vs added interlaminar stabilization for spinal stenosis
Results from this study demonstrated no significant differences in patient-reported outcomes between decompression alone vs. decompression with interlaminar stabilization for treatment of moderate to severe lumbar spinal stenosis. However, patients who underwent interlaminar stabilization had superior outcomes for composite clinical success.
“Altogether, we investigated more than 230 patients. Our study showed no significant difference in the individual [patient-reported outcomes] PROs between the treatments when viewed in isolation,” study co-author Michael Rauschmann, MD, told Healio.com/orthopedics. “However, the clinical composite success is statistically superior for interlaminar stabilization. Patients with Coflex presented a significantly increased walking distance, decreased compensatory pain management and maintained foraminal height extending the durability and sustainability of the decompression procedure.”
Researchers identified 230 patients randomized to decompression alone or decompression with interlaminar stabilization using the Coflex device (Paradigm Spine). At 3 months, 12 months and 24 months postoperatively, patients were evaluated for Oswestry Disability Index scores; neurological status; secondary surgery or lumbar injections; and device- or procedure-related adverse events. These outcomes were combined to define the composite clinical success. Secondary outcomes assessed included the VAS, Zurich Claudication Questionnaire scores, narcotics used, walking tolerance and radiographs. The follow-up rate was 91%.
Results showed that at 24 months, there were no significant differences in patient-reported outcomes. Patients who underwent decompression with interlaminar stabilization had superior outcomes for composite clinical success. Investigators noted patients who underwent decompression alone had a 1.75-times higher risk of secondary intervention compared to patients who underwent decompression with interlaminar stabilization. Patients who underwent decompression alone had 228% more lumbar injections.
According to researchers, there was a numerically greater rate of narcotics use seen with decompression alone at all time points postoperatively. Compared to baseline results, the walking distance test results postoperatively were statistically significantly different, with patients who underwent decompression with interlaminar stabilization having more than twice the improvement of patients who underwent decompression alone. Patients who underwent decompression with interlaminar stabilization maintained foraminal height and disc height compared with patients who underwent decompression alone, who saw a significant decrease in these measures at 24 months postoperatively. – by Monica Jaramillo
Disclosures: The study was funded by Paradigm Spine. Schmidt reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.