Orthopaedic oncology research faces several challenges, including insufficient patient volume at individual sites, so high-quality research to guide clinical practice has lagged behind other surgical subspecialties. However, the rigorous design, organization and execution of the first multi-centre randomized controlled trial in orthopaedic oncology (PARITY), led by CEO, has set a new standard for clinical research in the field. Capitalizing on the international momentum of PARITY and the advanced trial infrastructure of CEO, our goal is to expand our research program of high-quality international trials in the field to generate research findings that enhance clinical practice.
The PARITY trial is an ongoing international, multi-centre, double-blinded randomized controlled trial evaluating the effect of short versus long-duration postoperative prophylactic antibiotic regimens on the incidence of surgical site infection following surgical excision and endoprosthetic reconstruction of lower-extremity bone tumors in 600 patients. To our knowledge, this is the first multi-centre randomized controlled trial in orthopaedic oncology and has led to newly forged collaborations with surgeons at 45 sites across Canada, the United States, Argentina, Australia, South Africa, Brazil, Spain, the Netherlands, and India.
Principal Investigators: Dr. Michelle Ghert and Dr. Mohit Bhandari
Approximately 50% of sarcoma patients will develop a local or distant recurrence (metastasis). Once advanced metastases are detected, the median length of survival is 15 months, so long-term post-operative surveillance is widely considered an essential aspect of sarcoma management. However, adverse effects of intensive surveillance practices are also noteworthy, including the financial and emotional burden on patients, and concerns over unnecessary exposure to radiation. Our recent research program planning initiative identified post-operative surveillance as the highest-ranking research priority in orthopaedic oncology. Therefore, a robust clinical trial is warranted but will require widespread patient support. The aim of the SAFETY Protocol Development Study is to engage sarcoma patients to demonstrate patient willingness to participate in such a study, and develop a feasible, clinically relevant and patient-centered study protocol.
Principal Investigator: Michelle Ghert
Moving Forward Through Consensus
1. Schneider P, Evaniew N, Rendon JS, McKay P, Randall RL, Turcotte R, Vélez R, Bhandari M, Ghert M. Moving forward through consensus: Protocol for a modified Delphi approach to determine the top research priorities in the field of orthopaedic oncology. BMJ Open 2016; 6(5): e011780.
2. Schneider P, Evaniew N, McKay P, Ghert M. Moving Forward Through Consensus – A Modified Delphi Approach to Determine the Top Research Priorities in Orthopaedic Oncology. Clin Orthop Relat Res 2017 Dec: 475(12): 3044-55 [Epub ahead of print].