Department of Biomaterials, Institute for Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
Otol Neurotol. 2010 Jul;31(5):840-5. doi: 10.1097/MAO.0b013e3181de4b79.
This experimental study was undertaken to test the hypothesis that a new design of a craniofacial implant is more stable and shows faster integration than the currently used implant.
A total of 60 newly designed Cochlear Baha titanium implants (test) and 60 of the current design (control) were placed in the tibiae of 30 adult loop-eared rabbits. The animals were euthanized after 5, 14, or 28 days. The stability of the implants was measured with Implant Stability Quotient measurements and removal torque (RTQ) tests. The Student's t test for paired statistics were used for comparisons and a difference considered if p < 0.05.
The test implants showed a significantly higher RTQ at all time points and a steeper increase with time than the controls. The RTQ values were 19.0 (standard deviation [SD], 9.1) and 9.8 (SD, 5.6) Ncm for test and control implants, respectively, after 5 days; 27.6 (SD, 9.6) and 11.2 (SD, 3.9) Ncm after 14 days; and 43.3 (SD, 9.6) and 20.7 (SD, 14.1) Ncm after 28 days. Higher Implant Stability Quotient values were measured for the test implant at all time points. Calculations of shear stress to compensate for implant diameter revealed significantly higher values for test than for control implants after 14 and 28 days.
It is concluded that the new craniofacial implant was more stable and showed a faster integration than the currently used implant. The data from the present study suggest that the new implant may be suitable for early loading protocols.
本实验研究旨在验证以下假设，即新型颅面植入物的设计比目前使用的植入物更稳定，并且更快地整合。
将总共 60 个新设计的 Cochlear Baha 钛植入物（测试）和 60 个当前设计的植入物（对照）放置在 30 只成年垂耳兔的胫骨中。动物在 5、14 或 28 天后被安乐死。使用植入物稳定性商数（Implant Stability Quotient，ISQ）测量和取出扭矩（Removal Torque，RTQ）测试来测量植入物的稳定性。采用配对学生 t 检验进行比较，p<0.05 时认为有差异。
测试植入物在所有时间点的 RTQ 均明显较高，且随时间的增加呈陡峭上升。第 5 天，测试和对照植入物的 RTQ 值分别为 19.0（标准差 [SD]，9.1）和 9.8（SD，5.6）Ncm；第 14 天分别为 27.6（SD，9.6）和 11.2（SD，3.9）Ncm；第 28 天分别为 43.3（SD，9.6）和 20.7（SD，14.1）Ncm。在所有时间点，测试植入物的 ISQ 值均较高。为补偿植入物直径而计算的剪切应力显示，第 14 天和第 28 天，测试植入物的数值明显高于对照植入物。
新型颅面植入物比目前使用的植入物更稳定，并且更快地整合。本研究的数据表明，新型植入物可能适合早期加载方案。
