ROADMAP
Randomised arthroplasty infection
The ROADMAP Trial
Worldwide multidomain adaptive platform trial
Prosthetic joint infections (PJI) affect ~1–3% of hip and knee replacements and are difficult to treat due to bacterial biofilms on implants. ROADMAP is a global, Bayesian adaptive platform trial assessing both surgical (DAIR vs. one- or two-stage revision) and antibiotic (backbone vs. backbone + rifampicin, and antibiotic duration) interventions to optimise treatment outcomes. It adapts over time to focus on the most effective strategies across multiple domains.
Primary Outcome:
To determine which combination of surgical and antibiotic strategies lead to treatment success of prosthetic joint infection (PJI) at 12 months post-treatment.
PJI is a serious complication post-arthroplasty, involving biofilm-associated infections on implants
Background
Current treatments pair surgery with antibiotics, but optimal combinations and durations remain uncertain
Adaptive platform trials allow quicker conclusions, adding/removing interventions based on interim safety and efficacy data
Global, pragmatic adaptive platform with >2,500 adults in Australia, NZ, Canada, and the UK
Trial design
Three domains evaluated:
Surgical domain: Randomisation to DAIR vs. one/two-stage revision
Antibiotic choice: Backbone vs. backbone + rifampicin
Antibiotic duration: Short versus extended courses, including sub-study for Part A/B
Standard-of-care assessments only; no extra tests
Bayesian adaptive methods used; inferior arms dropped early, successful ones become controls
Outcomes measured at 3 and 12 months; primary endpoint at 12 months
Chief Investigators: Prof. Joshua Davis Univ. Newcastle & Prof. Laurens Manning (Univ. Western Australia)
Trial Management: Hunter Medical Research Institute (Univ. Newcastle, NSW) coordinating global sites
Senior Trial Manager: Univ. Newcastle (lead), NHMRC in Australia; regional sponsors in NZ, Canada, UK
Key connections
“The world of medical trials is really challenging. The work we do has true purpose. It's powerful to think about all the lives we are having a positive impact on in the process.”
Spiral’s contribution
Our Spiral Product Owner for ROADMAP is Mel Booth
Mel Booth wears many hats at Spiral. From managing sprints to building wireframes, working with developers, to liaising with our clients, Mel is the epitome of level-headed