Ghodasra Jason H, Daley Erika L, Hsu Erin L, Hsu Wellington K
Department of Orthopaedic Surgery, David Geffen School of Medicine at UCLA, 10833 Le Conte Ave., 76-143 CHS, Los Angeles, CA, 90095, USA,
Eur Spine J. 2014 Feb;23(2):426-34. doi: 10.1007/s00586-013-3074-0. Epub 2013 Oct 29.
The rabbit posterolateral intertransverse spine arthrodesis model has been widely used to evaluate spinal biologics. However, to date, the validity and reproducibility of performance of iliac crest bone graft, the most common and critical control group, has not been firmly established. We evaluated original research publications that utilized this model, identified which experimental conditions affected fusion rates, and developed an algorithm to predict fusion rates for future study designs.
A MEDLINE search was performed for publications through December, 2011 that utilized this model to evaluate fusion rates elicited by iliac crest autograft. All study parameters were recorded, and logistic regression analyses were performed to determine the effects of these variables on fusion rates as determined by either manual palpation or radiographs.
Seventy studies with 959 rabbits in 102 groups met the inclusion criteria. Excluding studies that measured fusion at 4 or fewer weeks or intentionally tried to decrease the fusion rate, the overall fusion rate for autograft was 58.3 ± 16.3 % (mean ± SD) as determined by manual palpation and 66.4 ± 17.8 % by plain radiographs. Regression analysis demonstrated a difference between these outcome measures with a trend towards significance (p = 0.09). Longer time points and larger volumes of autograft resulted in significantly greater reported fusion rates (p < 0.0001 and p < 0.05, respectively). Neither strain, age, weight, nor vertebral level significantly affected fusion rates.
Although experimental conditions varied across studies, time point evaluation and autograft volume significantly affected fusion rates. Despite some variability demonstrated across certain studies, we demonstrated that when the time point and volume of autograft were controlled for, the iliac crest control group of the rabbit posterolateral spinal arthrodesis model is both reliable and predictably affected by different experimental conditions.
兔后外侧横突间脊柱融合模型已被广泛用于评估脊柱生物材料。然而,迄今为止,最常见且关键的对照组——髂嵴骨移植的有效性和可重复性尚未得到确凿证实。我们评估了利用该模型的原始研究出版物,确定了哪些实验条件会影响融合率,并开发了一种算法来预测未来研究设计的融合率。
对截至2011年12月利用该模型评估髂嵴自体骨移植引发的融合率的出版物进行了MEDLINE检索。记录了所有研究参数,并进行了逻辑回归分析,以确定这些变量对通过手动触诊或X线片确定的融合率的影响。
102组中的70项研究(涉及959只兔子)符合纳入标准。排除在4周或更短时间内测量融合或有意试图降低融合率的研究后,通过手动触诊确定的自体骨移植总体融合率为58.3±16.3%(平均值±标准差),通过普通X线片确定的为66.4±17.8%。回归分析表明这两种结果测量方法之间存在差异,有显著趋势(p = 0.09)。更长的时间点和更大体积的自体骨移植导致报告的融合率显著更高(分别为p < 0.0001和p < 0.05)。品系、年龄、体重和椎体水平均未显著影响融合率。
尽管不同研究的实验条件各不相同,但时间点评估和自体骨移植体积显著影响融合率。尽管某些研究存在一定变异性,但我们证明,当控制自体骨移植的时间点和体积时,兔后外侧脊柱融合模型的髂嵴对照组既可靠,又会受到不同实验条件的可预测影响。