Department of Orthopaedics and Rehabilitation, Bone Healing Research Lab/Iowa Spine Research Center, University of Iowa, Iowa City, IA 52242, USA.
Spine (Phila Pa 1976). 2012 May 20;37(12):1017-21. doi: 10.1097/BRS.0b013e31824444c4.
Randomized, controlled study in a laboratory setting. Blinded observations/assessment of study outcomes.
The purpose of this study was to determine the performance characteristics of MASTERGRAFT PUTTY as a bone graft extender in a rabbit posterolateral spine fusion model.
The rabbit posterolateral fusion model is an established environment for testing of fusion concepts. It offers the opportunity to obtain radiographical, histological, and biomechanical data on novel fusion materials.
Thirty-six rabbits were entered into the study with 30 used for analysis. Bilateral posterolateral lumbar intertransverse fusions were performed at L5-L6. The lateral two-thirds of the transverse processes were decorticated and covered with graft material: autograft only (2.5-3.0 cc per side), 25% MASTERGRAFT PUTTY/75% autograft (3.0 cc total per side), or 50% MASTERGRAFT PUTTY and 50% autograft (3.0 cc total per side). Animals were humanely killed at 8 weeks postsurgery.
The autograft group had a 63% radiographical fusion rate (5 of 8) and correlated with manual palpation results (63%). The 25% MASTERGRAFT PUTTY group had a 73% radiographical fusion rate (8 of 11) and a manual palpation fusion rate of 64%. The 50% MASTERGRAFT PUTTY group demonstrated a 91% (10 of 11) radiographical fusion rate and 73% manual palpation fusion rate. Histologically, no inflammatory reactions were evident regardless of implant. The 2 MASTERGRAFT PUTTY groups had new bone in direct apposition to the MASTERGRAFT ceramic granules.
In this commonly used rabbit posterolateral fusion model, MASTERGRAFT PUTTY in an autograft extender mode produces clinically and radiographically similar results to autograft fusion alone.
实验室环境下的随机对照研究。对研究结果进行盲法观察/评估。
本研究旨在确定 MASTERGRAFT PUTTY 作为兔后路脊柱融合模型中骨移植物扩展剂的性能特征。
兔后路融合模型是一种用于融合概念测试的成熟环境。它为新型融合材料的影像学、组织学和生物力学数据提供了机会。
36 只兔子进入研究，其中 30 只用于分析。在 L5-L6 进行双侧后路腰椎横突间融合。横突的外侧三分之二进行皮质骨切除并用移植物覆盖：仅自体骨（每侧 2.5-3.0cc）、25%MASTERGRAFT PUTTY/75%自体骨（每侧总计 3.0cc）或 50%MASTERGRAFT PUTTY 和 50%自体骨（每侧总计 3.0cc）。术后 8 周对动物进行人道处死。
自体骨组影像学融合率为 63%（8/13），与手动触诊结果相关（63%）。25%MASTERGRAFT PUTTY 组影像学融合率为 73%（11/15），手动触诊融合率为 64%。50%MASTERGRAFT PUTTY 组显示 91%（11/12）的影像学融合率和 73%的手动触诊融合率。组织学上，无论植入物如何，均未观察到炎症反应。2 个 MASTERGRAFT PUTTY 组均有新骨直接与 MASTERGRAFT 陶瓷颗粒接触。
在这种常用的兔后路融合模型中，MASTERGRAFT PUTTY 作为自体骨扩展剂的模式产生了与单独自体骨融合相似的临床和影像学结果。
