The study authors examined 42 patients who met the Continued Access Program criteria and 13 who were randomly assigned to nonsurgical management in the pivotal Investigational Device Exemption study and failed to respond. There were 80 percent of the patients who completed the study with a two-year follow up.
The researchers found:
1. Sixty percent of the patients achieved clinically significant improvement in Symptom Severity domain of the Zurich Claudication Questionnaire; 58 percent achieved significant improvement in the Physical Function domain.
2. Seventy percent of the patients reported significant improvement in the Patient Satisfaction domain.
3. The average patient reported statistically significant improvement in all physical domains of the SF-36 except general health at 24 months.
4. The average improvement wasn’t as pronounce in the crossover patients for the ZCQ and SF-36 compared with the other patients.
5. Stenosis pain was the most frequently reported device-related or treatment-related adverse event, which three patients reported.
“On the basis of the COS cohort which was subject to several additional years of failed conservative treatment, overall success rate does not improve as greatly in patients with long-standing lumbar spinal stenosis symptoms,” concluded the study authors.
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