RESUMO
More than 1.2 million people are undergoing treatment for lumbar spinal stenosis (LSS) in the United States. Yet, therapeutic options for these patients are limited to either conservative treatments or highly invasive surgeries. A new image-guided interlaminar decompression procedure, mild(®), offers significant relief for many of these patients by debulking dorsal element hypertrophy while preserving structural stability. mild can be performed without general anesthesia and offers a short recovery period. A meta-analysis of four clinical patient series from multiple institutions in the United States evaluated over 250 patients for safety and clinical efficacy of the mild procedure. Clinical efficacy was evaluated at baseline and at three-month follow-up using validated patient reported outcomes (PRO) instruments including the ten-point Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI). Acute safety and patient outcomes was compared to the Spine Patient Outcomes Research Trial (SPORT). No device or procedure-related serious adverse events (SAEs) have been recorded with the mild procedure. Outcome metrics for patients treated with mild demonstrated statistically significant symptomatic improvement over baseline. When compared to open surgery, mild efficacy results compare favorably, and complication rates are much lower. mild is a safe and effective procedure that decompresses LSS in a minimally invasive manner while preserving the structural stability of the spine.
RESUMO
STUDY DESIGN: Retrospective analysis of a spine imaging center's records of patients with chronic low back pain referred by tertiary care facilities. OBJECTIVES: 1) To assess the interobserver reliability of detecting lumbar intervertebral disc high-intensity zone on T2-weighted magnetic resonance imaging, and 2) to assess the relation between high-intensity zone and discography or post-computed tomography in symptomatic patients with low back pain. SUMMARY OF BACKGROUND DATA: Two of the three previous studies on this subject found an association between high-intensity zone and the presence of Grade 4 anular disruption with discographic reproduction of patients' exact low back pain. METHODS: Records of patients with low back pain who had undergone lumbar spine discography injection and post-computed tomography from June 1995 to August 1996 were reviewed. Two independent observers were asked to identify the presence of an high-intensity zone from the T12-L1 disc to L5-S1 on T2-weighted magnetic resonance images. With this data, interobserver reliability was assessed with the kappa statistic. Concordant high-intensity zone results were then compared with the Dallas Discogram rating for anular disruption and to patients' subjective pain response to discography injection. With this data, the sensitivity, specificity, and predictive values of high-intensity zone for detecting disc disruption and pain response were calculated. RESULTS: The interobserver reliability for detecting a high-intensity zone in a given disc was fair to good (kappa = 0.57; 95% confidence interval = 0.44, 0.70). The sensitivity of high-intensity zone for detecting Grade 4 anular disruption and exact pain was poor (31%) but its specificity was relatively high (90%). The positive predictive value of a high-intensity zone was low (40%) for a severely disrupted and exactly painful disc. CONCLUSIONS: The interobserver reliability of detecting a high-intensity zone and the positive predictive value of the presence of a high-intensity zone for detecting a severely disrupted and exactly painful disc were much lower than previous studies have shown. The relatively low positive predictive value may be attributable to differences in sample characteristics or procedural variations, or suggest that a high-intensity zone is not indicative of exactly painful internal intervertebral disc disruption.
