Transforaminal lumbar interbody fusion vs. posterolateral instrumented fusion: cost-utility evaluation along side an RCT with a 2-year follow-up.

PURPOSE: Long-lasting low back pain is an increasing problem, and for some patients surgery is the final option for improvement. Several techniques for spinal fusion are available and the optimal technique remains uncertain. The objective of this study was to assess the cost-effectiveness and cost-utility of transforaminal lumbar interbody fusion (TLIF) compared to posterolateral instrumented fusion (PLF) from the societal perspective. METHODS: 100 Patients were randomized to TLIF or PLF (51/49) and followed for 2 years. Cost data were acquired from national registers, and outcomes were measured using the Oswestry Disability Index and SF-6D questionnaires. Conventional cost-effectiveness methodology was employed to estimate net benefit and to illustrate cost-effectiveness acceptability curves. The statistical analysis was based on means and bootstrapped confidence intervals. RESULTS: Results showed no statistically significant difference in either cost or effects although a tendency for the TLIF regimen being more costly on bed days (2,554) and production loss (1,915) was observed. The probability that TLIF would be cost-effective did not exceed 30 % for any threshold of willingness to pay per quality-adjusted life year. Sensitivity analysis was conducted and supported the statistical model for handling of missing data. CONCLUSION: TLIF does not seem to be a relevant alternative to PLF from a socioeconomic, societal point of view.

1997 Volvo Award winner in clinical studies. The effect of pedicle screw instrumentation on functional outcome and fusion rates in posterolateral lumbar spinal fusion: a prospective, randomized clinical study.

STUDY DESIGN: A prospective randomized clinical study. OBJECTIVES: To evaluate supplementary pedicle screw fixation (Cotrel-Dubousset) in posterolateral lumbar spinal fusion. SUMMARY OF BACKGROUND DATA: The rationale behind lumbar fusion is to eliminate pathologic motion to relieve pain. To improve fusion rates and to allow reduction, a rigid transpedicular screw fixation may be beneficial, but the positive effect of this may be counter-balanced by an increase in complications. METHODS: The inclusion criteria were severe, chronic low back pain from spondylolisthesis Grades 1 and 2 or from primary or secondary degenerative segmental instability. One hundred thirty patients were randomly allocated to receive no instrumentation (n = 66) or Cotrel-Dubousset instrumentation (n = 64) in posterolateral lumbar fusion. Variables were registered at the time of surgery and at 1 and 2 years after surgery. RESULTS: Follow-up was achieved in 97.7% of the patients. Fusion rates deduced from plain radiographs were not significantly different between instrumented and noninstrumented groups. The functional outcome assessed by the Dallas Pain Questionnaire improved significantly in both groups, and there were no significant differences in results between the two groups, except for significantly better (P < 0.06) functional outcome in relation to daily activities in the instrumented group when neural decompression had been performed. The global patients' satisfaction was 82% in the instrumented group versus 74% in the noninstrumented group (not significant). Fixation of instrumentation increased operation time, blood loss, and early reoperation rate significantly. Patients experienced only a few minor postoperative complications; none were major. Two infections appeared in the Cotrel-Dubousset group. Significant symptoms from misplacement of pedicle screws were seen in 4.8% of the instrumented patients. CONCLUSIONS: Lumbar posterolateral fusion with pedicle screw fixation increases the operation time, blood loss, and reoperation rate, and leads to a significant risk of nerve injury. The functional outcome improves significantly with high patient satisfaction, with or without instrumentation. No significant differences were observed between the two groups in functional outcome and fusion rate. The only gain in functional outcome from instrumentation was found in the daily activity category in patients with supplementary neural decompression. The results of this study do not justify the general use of pedicle screw fixation alone as an adjunct to posterolateral lumbar fusion.

Method for assessment of vascular reactivity in bone: in vitro studies on resistance arteries isolated from porcine cancellous bone.

Knowledge about vascular regulation in bone is central to the understanding of both normal and pathological bone physiology. This article describes a new method for direct assessment of the reactivity of bone blood vessels. Resistance arteries (diameter approximately 250 microns) were isolated from epiphyseal cancellous bone (porcine femoral condyle). Arterial segments (2 mm long) were mounted as ring preparations on a myograph, and isometric force development was measured continuously. Fifty-nine vessels from 31 pigs were investigated. The active force development was maximal at 0.9 x L100 in nine of 12 investigated arteries (L100 corresponds to the circumference the vessel would have if relaxed and exposed to a luminal pressure of 100 mm Hg [13.3 kPa]). In all subsequent experiments, the vessels were stretched to 0.9 x L100. Noradrenaline (2 x 10(-8) to 10(-5) M) induced a concentration-dependent vasoconstriction; mean maximal tension development was 3.69 N/m. This force development would enable the arteries to contract against a pressure of more than 22 kPa (165 mm Hg), indicating preserved function of the media smooth muscle. Response to acetylcholine (10(-7) to 10(-5) M) was observed in only two of 12 arteries. Bradykinin (10(-11) to 10(-6) M) induced a concentration-dependent and reproducible relaxation in all vessels; the relaxation was endothelium-dependent, since no effect of bradykinin was detected after mechanical removal of the endothelium. Sodium nitroprusside (10(-4) M) induced a reproducible and endothelium-independent vasorelaxation. The results demonstrate preserved function of both smooth muscle and endothelium in this preparation. The model allows pharmacological investigations of bone arteries under well defined conditions and enables studies on focal bone lesions and human bone tissue.

Effects of excessive caloric intake and caloric restriction on body weight and energy expenditure at rest and light exercise.

The individual response to overeating and semistarvation on energy expenditure at rest and light work before and after a test meal was investigated. This response was related to the change in dry body weight, measured as weight (W) minus total body water (TBW). Experiments were performed on 9 non-obese subjects: (a) with a normal habitual energy intake; (b) (overfeeding) with an extra energy intake of 12 MJ per day for two weeks; and (c) (semistarving) with an energy intake of only 2.1 MJ per day for 2 weeks. Measurements of VO2, VCO2, W and TBW were obtained at the end of each of the three periods. It was found that the perturbation in energy intake from normal to 20-25 MJ per day increased the energy expenditure. The magnitude of this increase was highly individual and inversely related to the change in dry body weight. Energy expenditure, measured under the four standardized conditions, after 2 weeks of starvation was lower than that obtained after the preceding overeating period. This decrease was also roughly inversely related to the change in dry body weight. The results support the idea that part of the regulation of body energy content takes place by way of a change in the efficiency of energy utilization and that the response to a perturbed energy intake varies considerably between subjects.