title: Methodology of clinical trials focusing on the PC-Fix clinical trials.
abstract: Once development and mechanical and biological laboratory testing have been completed, new technologies to be used in orthopaedic and trauma surgery must be investigated in humans before they can be used routinely. Prospective clinical investigations with or without randomization to standard treatments conducted according to the current standards and guidelines for Good Clinical Practice must be performed to prove the safety and efficacy of the new device. Furthermore, these tests serve to determine the specific indications, contraindications, tips and tricks as well as the pitfalls and how to avoid them. Last, but not least, the study must result in improved teaching of the use of the device and in improved follow-up of patients. The basis of every conclusion drawn from such a study is the complete documentation of each single use of the new device. We present the modalities and methodology for conducting a prospective clinical multicentre investigation in trauma surgery, focusing on the clinical trials carried out on the Point Contact Fixator (PC-Fix), a device for the internal fixation of long bone fractures developed as part of the scientific evolution towards the Less Invasive Stabilization Systems (LISS) now being introduced into clinical practice. Four prospective multicentre clinical investigations with an overall number of 1,229 PC-Fixators implanted from October 1993 to May 1998 were performed. To our knowledge this is the largest prospective series ever reported in orthopaedic trauma surgery to test a new device before market introduction. Due to a special documentation and implant replacement procedure, every PC-Fix implantation was documented. Very few patients were lost to long-term follow-up due to the personal commitment of the study monitors. Regular personal visits of the study monitor to the investigating hospitals and close communication between the surgeons, the engineers responsible for development, the study monitor, and the study sponsor meant that problems were identified and dealt with professionally without compromising the health of the patient. Case report forms were concise and had to be transmitted without delay. Handling of radiographs has become easier thanks to the transmission of digital images to the study centre via the internet. There are some aspects specific to trauma surgery which require special consideration and planning is essential, but clinical trials can be performed effectively.
authors.affiliation: AO ASIF Development Clinical Investigation, Davos-Platz, Switzerland. Christian.Hauke@hcuge.ch
authors.forename: C
authors.initials: C
authors.lastname: Hauke
authors.forename: A
authors.initials: A
authors.lastname: Meisser
authors.forename: S M
authors.initials: SM
authors.lastname: Perren
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000379:methods*; D005593:Fracture Fixation, Internal / Q000009:adverse effects / Q000379:methods*; D050723:Fractures, Bone / Q000601:surgery*; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods*; D016032:Randomized Controlled Trials as Topic; D015203:Reproducibility of Results; D012107:Research Design; D016896:Treatment Outcome