[Clinical research in orthopaedics--creation of a clinical trial unit in orthopaedics/trauma surgery].
OBJECTIVE
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.


METHODS
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.


CONCLUSIONS
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.
Otto
C
C
Klinik und Poliklinik für Orthopädie und Unfallchirurgie, Universität zu Köln, Köln.
Siewe
J
J
Zarghooni
K
K
Kaulhausen
T
T
Sauerland
S
S
Eysel
P
P
Cornely
O A
OA
D000046:Academic Medical Centers; D000047:Academies and Institutes / Q000458:organization & administration*; D035843:Biomedical Research / Q000193:education / Q000458:organization & administration*; D003479:Curriculum; D018795:Device Approval; D005858:Germany; D006785:Hospitals, University; D006801:Humans; D007396:Internship and Residency; D009983:Orthopedic Equipment; D009985:Orthopedics / Q000193:education / Q000458:organization & administration*; D016032:Randomized Controlled Trials as Topic; D013043:Specialties, Surgical; D014947:Wounds and Injuries / Q000601:surgery*