Conducting a multicenter trial: Learning from the JUPITER (justifying patellar instability treatment by early results) experience

Abstract

Multicenter trials in orthopedic surgery can have substantial advantages over single-center trials, including increasing enrollment resulting in enhanced statistical power and increased diversity of providers and patient populations resulting in improved generalizability of results (Chung et al., Plast Reconstr Surg. 126(2):515-23, 2010). However, they have a unique set of challenges related to the need for coordination and cooperation across multiple sites. In this chapter we use the JUPITER (Justifying Patellar Instability Treatment by Early Results) study as an example and discuss how a multicenter trial can be divided into several stages: discussion, planning, execution, and presentation/publication. At each stage, it is critically important that the investigators work closely together in a collaborative and supportive fashion and are willing to compromise work toward consensus. Specific recommendations regarding the conduct of orthopedic multicenter trials are provided.