RT Journal Article ID 4308c55143c16606 A1 van Oldenrijk, Jakob A1 Sierevelt, Inger N. A1 Schafroth, Matthias U. A1 Poolman, Rudolf W. T1 Design Considerations in Implant-Related Randomized Trials JF Journal of Long-Term Effects of Medical Implants JO JLT YR 2007 FD 2008-04-04 VO 17 IS 2 SP 153 OP 163 AB Implant-related research is particularly prone to produce biased results. Despite a common commitment to evidence-based principles (EBM) principles in current literature, a gap remains between the existing available evidence and its actual implementation in orthopaedic clinical practice. Knowledge of basic principles of implant related trial design is a prerequisite for critical appraisal of the value of scientific evidence and thereby the degree of uncertainty. This article discusses how the quality of implant-related randomized controlled trials (RCT) can be affected by the level of expertise, the choice of outcome measures, the allocation procedure, and the method of blinding. Taking these issues into consideration in the design of an implant-related study improves the value of the study, thereby achieving an unbiased assessment of the safety and efficacy of an innovative implant prior to its widespread implementation in daily health care. PB Begell House LK https://www.dl.begellhouse.com/journals/1bef42082d7a0fdf,4bb158c645db0e20,4308c55143c16606.html