Journal of neurosurgery. Spine
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Despite advances in technology and understanding in spinal physiology, reoperation for symptomatic adjacent-segment disease (ASD), same-level recurrent stenosis, and pseudarthrosis in elderly patients continues to occur. While revision lumbar surgery is effective, attention has turned to questions on the utility and value of the revision decompression and fusion procedure. To date, an analysis of the cost and health state gain associated with revision lumbar surgery in elderly patients with symptomatic pseudarthrosis, ASD, or same-level recurrent lumbar stenosis has yet to be performed. The aim of this study was to assess the long-term outcomes and cost-effectiveness of revision surgery in elderly patients with recurrent or persistent back and leg pain. ⋯ Revision decompression and fusion provided a significant gain in health state utility for elderly patients with symptomatic pseudarthrosis, same-level recurrent stenosis, or ASD, with a mean 2-year cost of $80,594 per QALY gained. When indicated, revision surgery for symptomatic ASD, same-level recurrent stenosis, and pseudarthrosis is a valuable treatment option for elderly patients experiencing persistent back and leg pain. Findings in this study provided a value measure of surgery that can be compared with future cost-per-QALY-gained studies of medical management or alternative surgical approaches.
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Randomized Controlled Trial
Retrograde ejaculation following single-level anterior lumbar surgery with or without recombinant human bone morphogenetic protein-2 in 5 randomized controlled trials: clinical article.
The aim of this study was to determine the incidence and assess specific risk factors in the postoperative development of retrograde ejaculation (RE) in men treated for degenerative lumbar disc disease at the L4-5 or L5-S1 level with stand-alone anterior interbody implants with or without recombinant human bone morphogenetic protein-2 (rhBMP-2). ⋯ In these 5 prospective randomized trials involving anterior lumbar interbody surgery, the use of rhBMP-2 was associated with a higher incidence of RE (3.4% vs 1.7%) but did not reach statistical significance. Based on surgical approach, the difference in rates of RE was statistically significant. This study reports on the outcomes of 5 prospective randomized FDA-approved investigational device exemption trials. Registration for studies became law in 2007. Four of these trials were completed before the law went into effect. The registration number for the lumbar disc arthroplasty trial is NCT00635843.
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Treatment effectiveness following spine surgery is usually gauged with the help of patient-reported outcome (PRO) questionnaires. Although these questionnaires assess pain, disability, and general health state, their numerical scores lack direct, clinically significant meaning. Thus, the concept of minimum clinically important difference (MCID) has been introduced, which indicates the smallest change in an outcome measure that reflects clinically meaningful improvement to patients. The authors set out to determine anterior cervical discectomy and fusion (ACDF)-specific MCID values for the visual analog scale (VAS), Neck Disability Index (NDI), 12-Item Short-Form Health Survey (SF-12), and EQ-5D (the EuroQol health survey) in patients undergoing ACDF for cervical radiculopathy. ⋯ The ACDF-specific MCID is highly variable depending on the calculation technique used. The MDC approach seems to be most appropriate for MCID calculations in the ACDF population, as it provided a threshold value above the 95% confidence interval of nonresponders (greater than the measurement error) and was closest to the average change of most PROs reported by responders. When the MDC method was applied with the NASS patient satisfaction scale as the anchor, the MCID thresholds were 2.6 points for VAS-NP, 4.1 points for VAS-AP, 17.3% for NDI, 8.1 points for SF-12 PCS, 4.7 points for SF-12 MCS, and 0.24 QALY for EQ-5D.