Jacobs Zaina, Schipani Rossana, Pastrama Maria, Ahmadi Seyed Mohammad, Sajadi Banafsheh
Amber Implants BV, The Hague, The Netherlands.
Orthopedic Biomechanics Group, Department of Biomedical Engineering, Eindhoven University of Technology, The Netherlands.
J Orthop Res. 2025 Jan;43(1):139-152. doi: 10.1002/jor.25974. Epub 2024 Sep 16.
This study aimed to investigate the biocompatibility and osseointegration of novel titanium (Ti) implants with a perforated part with high surface roughness (Ra >4 μm) and a smooth solid part (test group), as compared to smooth solid Ti implants (control group; Ra < 0.8 μm). Test and control implants were implanted in rabbit femurs. After 4 and 15 weeks, host tissue reaction and quality of tissue formed were evaluated with histopathology, while micro-CT scans were used to quantitatively assess bone-implant contact (BIC), surrounding bone formation, and bone ingrowth. After 4 and 15 weeks, minimal host reaction was found in the test group. Histopathological analysis showed new bone formation around the implants in both the test and control groups after 4 weeks. Furthermore, additional bone growth was often observed within the holes of the test implants. After 15 weeks, the test implants showed high bone ingrowth and the presence of mature bone in direct contact with the implant surface, whereas, bone ingrowth was poorer for the control group with 30% of the control implants, showing larger gaps at the bone-implant interface. Quantitative micro-CT analysis revealed comparable BIC and bone formation in both groups at 4 weeks, but higher BIC and more bone formation in the test group than in the control group after 15 weeks. No significant differences were observed in any of the analyses. In conclusion, partially perforated, high-roughness Ti implants showed excellent osseointegration and minimal host reaction, indicating their potential for orthopedic applications in bone repair and regeneration.
本研究旨在调查新型钛(Ti)植入物的生物相容性和骨整合情况。该植入物具有高表面粗糙度(Ra>4μm)的穿孔部分和光滑的实心部分(试验组),并与光滑实心Ti植入物(对照组;Ra<0.8μm)进行比较。将试验组和对照组植入物植入兔股骨。4周和15周后,采用组织病理学评估宿主组织反应和形成组织的质量,同时使用微型计算机断层扫描(micro-CT)定量评估骨-植入物接触(BIC)、周围骨形成和骨长入情况。4周和15周后,试验组发现宿主反应极小。组织病理学分析显示,4周后试验组和对照组植入物周围均有新骨形成。此外,在试验植入物的孔内经常观察到额外的骨生长。15周后,试验植入物显示出较高的骨长入,且存在与植入物表面直接接触的成熟骨,而对照组的骨长入较差,30%的对照植入物在骨-植入物界面处显示出较大间隙。微型计算机断层扫描定量分析显示,两组在4周时的BIC和骨形成相当,但15周后试验组的BIC和骨形成高于对照组。在任何分析中均未观察到显著差异。总之,部分穿孔、高粗糙度的Ti植入物显示出优异的骨整合和极小的宿主反应,表明它们在骨修复和再生的骨科应用中具有潜力。