ROADMAP –
Randomised Arthroplasty Infection Worldwide Multidomain Adaptive Platform trial

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.

ROADMAP

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.

Background

  • PJI is a serious complication post-arthroplasty, involving biofilm-associated infections on implants

  • 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

Trial design

  • Global, pragmatic adaptive platform with >2,500 adults in Australia, NZ, Canada, and the UK

  • Three domains evaluated:

  1. Surgical domain: Randomisation to DAIR vs. one/two-stage revision

  2. Antibiotic choice: Backbone vs. backbone + rifampicin

  3. Antibiotic duration: Short vs. 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

Key connections

  • Chief Investigators: Prof. Joshua Davis (Univ. NSW) & 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

“My systematic thinking approach is focused on delivering platform solutions that improve process efficiencies for Spiral's clients and contribute to their trial's success.”

Spiral’s contribution

Our Spiral Project Lead for T1D+ is Gosia Costar

Gosia Costar is one of our dedicated Project Managers here at Spiral. Her passion for enhancing health outcomes through innovative technology makes her the perfect addition to our team.

More about the study

Visit the official ROADMAP trial site for patient and investigator info, protocol documents, FAQs, and videos: roadmaptrial.com

Stay Connected with Spiral

Never miss a bit or a byte! Join us for industry insights, sector events, novel trial advancements, and more