In the Interim... Platform Trial in Orthopaedic Surgery
Dr. Nathan O’Hara (University of Maryland), Dr. Gerard Slobogean (UC Irvine), and Dr. Sheila Sprague (McMaster University) describe the launch and design of the Musculoskeletal Adaptive Platform Trial (MAPT)—the first major adaptive platform trial in orthopaedic surgery. The discussion covers MAPT’s master protocol structure, patient-centered endpoint framework, and operational strategies for multinational implementation. Focus areas include the FASTER-HIP domain’s use of Bayesian modeling with a hierarchical clinical endpoint and the standards established for adaptation, data coordination, and future scalability. Listeners gain insight into a trial infrastructure designed to lower barriers for evidence generation and facilitate ongoing evidence generation in musculoskeletal trauma care.
Key Highlights
- MAPT as a scalable, master protocol for orthopaedic intervention evaluation
- Hierarchical, patient-centered endpoint (survival, 4-level ambulation, days alive/out of hospital), analyzed with a Bayesian-modeled, non-parametric win ratio
- Domain-specific adaptation thresholds based on clinical differentiation
- Interim analyses after 100 patients, then every 50, informing early adaptation
- 40 sites across US, Canada, and Europe, centralized data management at McMaster
- A unified DSMB structure with capacity for domain-specific expertise as needed
- Tiered protocol access: open sharing, collaboration, direct integration
- Infrastructure enables rapid domain addition and multi-investigator participation
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