RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

Eduardo Angeli Malavolta; Marco Kawamura Demange; Riccardo Gomes Gobbi; Marta Imamura; Felipe Fregni

doi:10.1016/S2255-4971(15)30261-5

RANDOMIZED CONTROLLED CLINICAL TRIALS IN ORTHOPEDICS: DIFFICULTIES AND LIMITATIONS

Rev Bras Ortop. 2015 Nov 17;46(4):452-9. doi: 10.1016/S2255-4971(15)30261-5. eCollection 2011 Jul-Aug.

Authors

Eduardo Angeli Malavolta¹, Marco Kawamura Demange², Riccardo Gomes Gobbi³, Marta Imamura⁴, Felipe Fregni⁵

Affiliations

¹ Attending Physician in the Shoulder and Elbow Group, Institute of Orthopedics and Traumatology, School of Medicine, University of São Paulo (USP), São Paulo, Brazil.
² MSc in Medicine. Attending Physician in the Knee Group, Institute of Orthopedics and Traumatology, School of Medicine, University of São Paulo (USP), São Paulo, Brazil.
³ Attending Physician in the Knee Group, Institute of Orthopedics and Traumatology, School of Medicine, University of São Paulo (USP), São Paulo, Brazil.
⁴ PhD in Medicine. Collaborating Professor in the School of Medicine, University of São Paulo (USP); Physician in the Division of Physical Medicine and Rehabilitation, Institute of Orthopedics and Traumatology, School of Medicine, University of São Paulo (USP), São Paulo, Brazil.
⁵ PhD in Medicine. Head of the Neuromodulation Laboratory and Clinical Research Teaching Center, Harvard Medical School, Boston, MA.

Abstract

Randomized controlled clinical trials (RCTs) are considered to be the gold standard for evidence-based medicine nowadays, and are important for directing medical practice through consistent scientific observations. Steps such as patient selection, randomization and blinding are fundamental for conducting a RCT, but some additional difficulties are presented in trials that involve surgical procedures, as is common in orthopedics. The aim of this article was to highlight and discuss some difficulties and possible limitations on RCTs within the field of surgery.

Keywords: Comparative Study; Evidence-Based Medicine; Orthopedics; Randomized Controlled Trials as Topic.

Publication types

Review