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Journal of Long-Term Effects of Medical Implants

ISSN Print: 1050-6934
ISSN Online: 1940-4379

Journal of Long-Term Effects of Medical Implants

DOI: 10.1615/JLongTermEffMedImplants.v17.i2.80
pages 153-163

Design Considerations in Implant-Related Randomized Trials

Jakob van Oldenrijk
Department of Orthopedic Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
Inger N. Sierevelt
Department of Orthopedic Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
Matthias U. Schafroth
Department of Orthopedic Surgery, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
Rudolf W. Poolman
Department of Orthopedic Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands

ABSTRACT

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.