title: [Clinical trials investigating the therapeutic benefit of medical devices in orthopaedics and trauma surgery: practice examples plus commentary].
abstract: Patients recognise relevant symptoms of the two leading diseases in orthopaedics and trauma surgery: osteoarthritis and fractures. Treatment effects can be demonstrated by patient reported outcomes. Total hip arthroplasty as an example for standard treatment regimen achieves large treatment effects. It is hard to demonstrate an additional benefit against standard treatment while observing ceiling effects. Alternative instruments are needed. Navigated total knee arthroplasty is done for better control of the postoperative axis as well as to reduce the revision burden. The time interval needed to demonstrate the decrease in revision has not yet passed. Additional benefits of total knee navigation have been observed for certain patient populations and for the training of physicians. These benefits have not been investigated so far. Using registries, expert opinions and case series the desired benefit from the use of medical devices can be shown. Safety is one major aspect of innovative medical devices as an additional benefit. The safety paradigm needs intense investigation in the future. The IDEAL Statement provides the clinical researcher with the methodological framework. The METEOR Statement focused on the medical problem and the possible benefit with using innovative medical devices. Within these recommendations a broad number of study types can be employed to demonstrate the benefits for patients.
authors: Orthopädische Universitätsklinik Carl Gustav Carus, Technische Universität Dresden. Stephan.Kirschner@uniklinikum-dresden.de
authors: Stephan
authors: S
authors: Kirschner
mesh_terms: D019645:Arthroplasty, Replacement, Knee / Q000295:instrumentation; D001860:Bone Plates / Q000592:standards; D018795:Device Approval; D005858:Germany; D006622:Hip Prosthesis / Q000592:standards; D006801:Humans; D009313:National Health Programs; D009983:Orthopedic Equipment / Q000592:standards*; D009984:Orthopedic Fixation Devices / Q000592:standards*; D019637:Orthopedic Procedures / Q000295:instrumentation*; D020370:Osteoarthritis, Knee / Q000601:surgery; D011358:Product Surveillance, Postmarketing; D011474:Prosthesis Design / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D025321:Surgery, Computer-Assisted / Q000295:instrumentation