BACKGROUND: Neurogenic claudication due to symptomatic lumbar spinal stenosis (LSS) is a painful condition causing significant functional disability. While the cause of LSS is multifactorial, thickened ligamentum flavum (LF) accounts for up to 85% of spinal canal narrowing. mild percutaneous lumbar decompression allows debulking of the hypertrophic LF while avoiding the morbidities frequently associated with more invasive surgical procedures. METHODS: In this prospective case series study, consecutive LSS patients presenting with neurogenic claudication were treated with percutaneous lumbar decompression. Efficacy was evaluated using the Pain Disability Index (PDI) and Roland-Morris Disability Questionnaire. Pre- and postprocedure Standing Time, Walking Distance, and Visual Analog Score (VAS) were also monitored. Significant device- or procedure-related adverse events were reported. RESULTS: The mild procedure was successfully performed on forty patients. At twelve months, both PDI and Roland-Morris showed significant improvement of 22.6 points (ANOVA, P<0.0001) and 7.7 points (ANOVA, P<0.0001), respectively. Walking Distance, Standing Time, and VAS improvements were also statistically significant, increasing from 246 to 3,956 feet (ANOVA, P<0.0001), 8 to 56 minutes (ANOVA, P<0.0001), and 7.1 to 3.6 points (ANOVA, P<0.0001), respectively. Tukey HSD test found improvement in all 5-outcome measures to be significant from baseline at each follow-up interval. No significant device- or procedure-related adverse events were reported. CONCLUSION: This study demonstrated significant functional improvement as well as decreased disability secondary to neurogenic claudication after mild procedure. Safety, cost-effectiveness, and quality-of-life outcomes are best compared with comprehensive medical management in a randomized controlled fashion and, where ethical, to open lumbar decompression surgery.
BACKGROUND:Neurogenic claudication due to symptomatic lumbar spinal stenosis (LSS) is a painful condition causing significant functional disability. While the cause of LSS is multifactorial, thickened ligamentum flavum (LF) accounts for up to 85% of spinal canal narrowing. mild percutaneous lumbar decompression allows debulking of the hypertrophic LF while avoiding the morbidities frequently associated with more invasive surgical procedures. METHODS: In this prospective case series study, consecutive LSS patients presenting with neurogenic claudication were treated with percutaneous lumbar decompression. Efficacy was evaluated using the Pain Disability Index (PDI) and Roland-Morris Disability Questionnaire. Pre- and postprocedure Standing Time, Walking Distance, and Visual Analog Score (VAS) were also monitored. Significant device- or procedure-related adverse events were reported. RESULTS: The mild procedure was successfully performed on forty patients. At twelve months, both PDI and Roland-Morris showed significant improvement of 22.6 points (ANOVA, P<0.0001) and 7.7 points (ANOVA, P<0.0001), respectively. Walking Distance, Standing Time, and VAS improvements were also statistically significant, increasing from 246 to 3,956 feet (ANOVA, P<0.0001), 8 to 56 minutes (ANOVA, P<0.0001), and 7.1 to 3.6 points (ANOVA, P<0.0001), respectively. Tukey HSD test found improvement in all 5-outcome measures to be significant from baseline at each follow-up interval. No significant device- or procedure-related adverse events were reported. CONCLUSION: This study demonstrated significant functional improvement as well as decreased disability secondary to neurogenic claudication after mild procedure. Safety, cost-effectiveness, and quality-of-life outcomes are best compared with comprehensive medical management in a randomized controlled fashion and, where ethical, to open lumbar decompression surgery.
Authors: Carolina G Fritsch; Manuela L Ferreira; Christopher G Maher; Robert D Herbert; Rafael Z Pinto; Bart Koes; Paulo H Ferreira Journal: Eur Spine J Date: 2016-07-21 Impact factor: 3.134
Authors: Nagy A Mekhail; Shrif J Costandi; Sherif Armanyous; Ricardo Vallejo; Lawrence R Poree; Lora L Brown; Stanley Golovac; Timothy R Deer Journal: Med Devices (Auckl) Date: 2020-06-04