Comparing cost-effectiveness of X-Stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial.

STUDY DESIGN: Randomized clinical trial with 2-year follow-up. OBJECTIVE: To compare the cost-effectiveness of X-stop to minimally invasive decompression in patients with symptomatic lumbar spinal stenosis. SUMMARY OF BACKGROUND DATA: Lumbar spinal stenosis is the most common indication for operative treatment in elderly. Although surgery is more costly than nonoperative treatment, health outcomes for more than 2 years were shown to be significantly better. Surgical treatment with minimally invasive decompression is widely used. X-stop is introduced as another minimally invasive technique showing good results compared with nonoperative treatment. METHODS: We enrolled 96 patients aged 50 to 85 years, with symptoms of neurogenic intermittent claudication within 250-m walking distance and 1- or 2-level lumbar spinal stenosis, randomized to either minimally invasive decompression or X-stop. Quality-adjusted life-years were based on EuroQol EQ-5D. The hospital unit costs were estimated by means of the top-down approach. Each cost unit was converted into a monetary value by dividing the overall cost by the amount of cost units produced. The analysis of costs and health outcomes is presented by the incremental cost-effectiveness ratio. RESULTS: The study was terminated after a midway interim analysis because of significantly higher reoperation rate in the X-stop group (33%). The incremental cost for X-stop compared with minimally invasive decompression was &OV0556;2832 (95% confidence interval: 1886-3778), whereas the incremental health gain was 0.11 quality-adjusted life-year (95% confidence interval: -0.01 to 0.23). Based on the incremental cost and effect, the incremental cost-effectiveness ratio was &OV0556;25,700. CONCLUSION: The majority of the bootstrap samples displayed in the northeast corner of the cost-effectiveness plane, giving a 50% likelihood that X-stop is cost-effective at the extra cost of &OV0556;25,700 (incremental cost-effectiveness ratio) for a quality-adjusted life-year. The significantly higher cost of X-stop is mainly due to implant cost and the significantly higher reoperation rate. LEVEL OF EVIDENCE: 2.

Cost-effectiveness of total disc replacement versus multidisciplinary rehabilitation in patients with chronic low back pain: a Norwegian multicenter RCT.

STUDY DESIGN: Randomized clinical trial with 2-year follow-up. OBJECTIVE: To evaluate the cost-effectiveness of total disc replacement (TDR) versus multidisciplinary rehabilitation (MDR) in patients with chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: The existing studies on CLBP report cost-effectiveness of fusion surgery versus disc replacement and fusion versus rehabilitation. This study evaluated the cost-effectiveness of TDR versus MDR. METHODS: Between April 2004 and May 2007, 173 patients with CLBP (>1 yr) were randomized to TDR (n = 86) or MDR (n = 87). Treatment effects (Euro Qol 5D [EQ-5D] and Short Form 6D [SF-6D]) and relevant direct and indirect costs at 6 weeks and at 3, 6, 12, and 24 months after treatment were assessed. Gain in quality-adjusted life years (QALYs) after 2 years was estimated. Cost-effectiveness was expressed as an incremental cost-effectiveness ratio. RESULTS: The mean QALYs gained (standard deviation) using EQ-5D was 1.29 (0.53) in the TDR group and 0.95 (0.52) in the MDR group, a significant difference of 0.34 (95% confidence interval 0.18-0.50). The mean total cost per patient in the TDR group was &OV0556;87,622 (58,351) compared with &OV0556;74,116 (58,237) in the MDR group, which was not significantly different (95% confidence interval: -4041 to 31,755). The incremental cost-effectiveness ratio for the TDR procedure varied from &OV0556;39,748 using EQ-5D (TDR cost-effective) to &OV0556;128,328 using SF-6D (TDR not cost-effective). The dropout rate was 20% (15% TDR group, 24% MDR group). Five patients moved from the MDR to the TDR group, whereas 9 patients randomized to TDR declined surgery. Using per-protocol analysis instead of intention-to-treat analysis indicated that TDR was not cost-effective, irrespective of the use of EQ-5D or SF-6D. CONCLUSION: In this study, TDR was cost-effective compared with MDR after 2 years when using EQ-5D for assessing QALYs gained and a willingness to pay of &OV0556;74,600 (kr500,000/QALY). TDR was not cost-effective when SF-6D was used; therefore, our results should be interpreted with caution. Longer follow-up is needed to accurately assess the cost-effectiveness of TDR. LEVEL OF EVIDENCE: 2.

Magnetic resonance imaging assessment of the alar ligaments in whiplash injuries: a case-control study.

STUDY DESIGN: Case-control study. OBJECTIVE: To use high-resolution magnetic resonance imaging (MRI) in assessing signal intensity areas in the alar ligaments. SUMMARY OF BACKGROUND DATA: Conflicting evidence exists whether areas of high signal intensity in the alar ligament on MRI are more frequent in whiplash patients than in noninjured control subjects. METHODS: A case-control designed study of 173 subjects included one group with persistent whiplash associated disorder Grade I-II after a car accident (n = 59), one with chronic nontraumatic neck pain (n = 57) and one group without neck pain or previous neck trauma (n = 57). High-resolution proton-weighted MRI in 3 planes was used. The images were independently evaluated by two experienced neuroradiologists who were blinded to patient history and group allocation. The alar ligaments were evaluated according to a 4-point grading scale; 0 = low signal intensity throughout the entire cross section area, 1 = high signal intensity in one third or less, 2 = high signal intensity in one-third to two thirds, and 3 = high signal intensity in two thirds or more of the cross section area. RESULTS: Alar ligament changes Grade 0 to 3 were seen in all 3 diagnostic groups. Areas of high signal intensity (Grade 2-3) were found in at least one alar ligament in 49% of the patients in the whiplash associated disorder Grade I-II group, in 33% of the chronic neck pain group and in 40% of the control group (chi, P = 0.22). CONCLUSION.: The previously reported assumption that these changes are due to a trauma itself is not supported by this study. The diagnostic value and the clinical relevance of magnetic resonance detectable areas of high intensity in the alar ligaments are questionable.