Otto C, Siewe J, Zarghooni K, Kaulhausen T, Sauerland S, Eysel P, Cornely O A
Klinik und Poliklinik für Orthopädie und Unfallchirurgie, Universität zu Köln, Köln.
Z Orthop Unfall. 2010 Mar;148(2):145-8. doi: 10.1055/s-0029-1240660.
The clinical trial is the link between research and medical practice and facilitates evidence-based therapies. There are specific difficulties to be faced when executing clinical trials related to surgical services (learning curve of the surgeon, blinding etc.). As a result, surgical randomised controlled clinical trials (RCT) are underrepresented in the total number of RCTs.
To make it easier to implement surgical RCT, the Clinical Trial Unit for Orthopaedics and Trauma Surgery was established. Training of the supporting physicians was reached by rotations in the structures of CHIR-Net, a BMBF-funded network created to build up a region-wide surgical research infrastructure.
RESULT/CONCLUSION: Supported by the regional CHIR-Net Center and the regional Clinical Trial Center, a research institute was thus founded with the aim of contributing to a long-term improvement in clinical research in orthopaedics and trauma surgery.
临床试验是研究与医学实践之间的纽带，有助于循证治疗。在开展与外科服务相关的临床试验时会面临一些特殊困难（如外科医生的学习曲线、盲法等）。因此，外科随机对照临床试验（RCT）在RCT总数中所占比例较低。
为了更便于实施外科RCT，成立了骨科与创伤外科临床试验单元。通过在CHIR-Net结构中的轮转培训辅助医师，CHIR-Net是一个由德国教育与研究部资助的网络，旨在建立区域范围内的外科研究基础设施。
结果/结论：在区域CHIR-Net中心和区域临床试验中心的支持下，由此成立了一个研究所，旨在促进骨科与创伤外科临床研究的长期改善。
