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How can I become involved?


To become involved in the ROADMAP trial the following steps are recommended:

1.      Global Participation: While the trial is currently active in Australia and New Zealand (with plans to include Canada and the UK in 2025), it aims to expand globally. 

2.      Self-Funding Requirement: Countries not yet included must be self-funded to support study activities, typically through applied research grants. 

3.       Contact the Team: If interested, reach out to the Trial Management Group (TMG) at TMG@roadmaptrial.com to discuss opportunities and potential involvement.

This approach ensures that new sites meet the trial’s operational and financial needs while contributing to its global objectives.

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What are the requirements?

Sites must have support and investigators from both the Infectious Diseases and Orthopaedic Units to facilitate communication and collaboration on trial activities and post-surgery patient care.

Furthermore, sites are required to manage a minimum of 20 prosthetic joint infections each year.

Answers to

Frequently Asked Questions

Resources for Investigators

For Investigators

Does a site have to be included in all Domains of the trial?
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To reach definitive answers to the questions posed in ROADMAP it is preferred to have all Domains active at each site however, it is recognised that some sites will opt out of Domains for different reasons.

Sites can elect to participate in all domains including the Registry or select which domains they have the capacity to be involved with and which domains the Infectious diseases and orthopaedic teams are comfortable enrolling participants into.
Does the trial design include randomisation to DAIR or revision for late acute infection?
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Yes, the surgical domain does involve randomisation to DAIR or revision for late acute PJIs – although this domain is not essential for all sites to participate in. The Domain does include provision for surgeon’s discretion based on the patient, patient history etc.  The randomisation is a strong recommendation but if not adhered to will not be considered a PD. It will be dealt with in analysis.
Can private hospitals be involved in ROADMAP as a participating site?
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Yes. Both public and private hospitals and clinics can be participating sites if they meet the criteria listed previously. A caveat may be, if fees for Research Governance are considered by the regional trial steering committees (TSC) to be outside budget capacity.  This is due to ROADMAP being a collaborative group trial sponsored and funded within strict grant guidelines in each regional area.
Does ROADMAP need a local laboratory to be formally involved?
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ROADMAP is designed to be an embedded comparative effectiveness trial that does not request any assessments other than normal good clinical practise. The ROADMAP specific database will ask for results recorded in the participants medical file to be entered into the ROADMAP database however, no specific testing is required.  

In the future, ROADMAP plans to collect isolates for a ROADMAP PJI biobank and a potential sub-study however, the process for this has not been established.  It is likely that the process will involve local laboratory storage of frozen isolates till batch sending is requested to the biobank.
Can patients be randomised to DAIR vs. staged Revision if they require 12 weeks of IV antibiotics?
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Patients can be randomised as long as they don’t meet the exclusion criterion of “difficult to treat organism” such as fungus or extensively drug-resistant bacteria.
Are patients excluded from the Antibiotic ChoiceDomain if rifampicin is contraindicated?
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Unfortunately, they are excluded if there is a contraindication and known intolerance. However, can be included if in the case of a drug interaction it is possible and ethical to cease or withhold or to switch the interacting drug to an acceptable alternative.
Are patients with a hemiarthroplasty (hip) eligible for enrolment into ROADMAP?
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Yes.
Are patients with a global modular replacement system (GMRS) of the knee or hip eligible for ROADMAP?
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As these are generally revision prostheses, they are platform eligible but excluded from the surgical domain.
Does surgery at another hospital violate the study protocol?
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No, a study protocol violation will not be recorded as this is acknowledged as a possibility in some centres and has been allowed to occur within the protocol.
Can a patient remain in the trial if surgery is at secondary hospital and data collection will be difficult for follow up?
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It is the hope that the patient is accessible for data collection in relation for follow up and outcomes data collection at Day 100 and Day 365 however, if it is known at baseline that the patient is likely to be transferred to another hospital to which investigators have no access to records, the patient would meet the platform exclusion criterion “not likely to be accessible for follow up over the next 12 months”.
Is the pathogen considered in the study domains and approach?
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Yes. Pathogen must not be considered to be a “difficult to treat organism” such as fungus or extensively drug-resistant bacteria. For the Antibiotic Choice Domain, growth of a Gram-positive organism is required. Detailed consideration can be found in the domain specific appendices however an excerpt of microbial consideration can be found here.
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