AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

ROADMAP Clinical Trial

RecruitingPhase 4Ages 18 Years - anyAllUniversity of Newcastle, Australia
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

Artificial joint infections are treated with different types of antibiotics and surgery. The ROADMAP study aims to find out which treatments currently used work best in regards to surgery, antibiotic choice as well as the time taking antibiotics. The study will compare different treatments against each other to see which treatment or treatment combination works to provide the best outcome and cure at 12 months. The study will focus on adults with infected artificial hips and knees. ROADMAP trial looks at normal good clinical care and does not ask any person taking part in the study to have any extra tests or treatments. If a person takes part in the study they will: * Sign a consent form * Give permission for infection and treatment information to be collected and entered into a central ROADMAP specific database and a separate registry of prosthetic joint infection patients. This medi

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. "Confirmed" or "Likely" Prosthetic joint infection of a large joint according to European Bone and Joint Infection Society (EBJIS) criteria (2021) 2. Physically present at participating hospital at time of eligibility assessment 3. "Current" prosthetic joint infection, meaning symptoms and/or signs of the PJI are present at the time of eligibility assessment. Exclusion Criteria: Potentially eligible participants meeting any of the following criteria at the time of eligibility assessment for platform entry will be excluded from the randomised platform (but may still participate in the registry): 1. The index prosthetic joint is a shoulder, elbow, wrist or ankle. 2. Known previous participation in the randomised ROADMAP randomised platform for the index joint. 3. Known previous participation in the randomised ROADMAP platform for a joint other than the index joint within the 12 months prior to eligibility assessment 4. Treating clinician believes that death is imminent and inevitable. 5. Treatment is not with curative intent. 6. Patient is not classifiable into one of the three defined silos. 7. Patient is unlikely to be accessible for follow up over the 12 months following platform entry. 8. Treating team deems enrolment in the study is not in the best interests of the patient. To be included in any of the following Domains the participant must be eligible for the PLATFORM ( as listed above) and none of the platform-level exclusion criteria AND all of the domain-level inclusion and none of the domain-level exclusion criteria. Domain-specific eligibility criteria Each domain may have additional criteria for eligibility. Participants who fulfil the above criteria will be assessed for enrolment into all domains active at a participating site. At least 2 interventions (which may include standard of care) within a domain must be available to an eligible participant in order for that participant to enter the domain. The minimum number of interventions within a domain is two. The availability of interventions within domains will be region- and site-specific, although the default position is that all interventions within a domain will be available at all sites. Surgical Strategy Domain: Late Acute Silo inclusion criteria Patient is in the Late Acute silo, meaning all of the following 3 criteria are met: 1. Onset of symptoms is \>30 days after implantation of the index joint 2. Treating team feel that either DAIR or revision is appropriate for this patient. 3. The infected prosthesis is a primary arthroplasty. Surgical Strategy Domain: Late Acute Silo exclusion criteria <!-- --> 1. Any previous episode of native joint septic arthritis or PJI in the index joint 2. A definitive DAIR has already occurred for this episode of infection. 3. A revision has already occurred for this episode of infection 4. Loosening or instability of any component of the prosthesis 5. Predicted inadequate soft tissue coverage for wound closure 6. One or more of the causative organisms is a fungus or a "difficult to treat" bacterium. 7. Treating team deems enrolment in this domain is not in the best interests of the patient. Antibiotic Choice Domain inclusion criteria 1. The time of eligibility assessment is between 48h and 7 days following initial surgical treatment. 2. One or more of the causative organisms is a Gram-positive of interest OR the infection is culture negative. Antibiotic Choice Domain exclusion criteria <!-- --> 1. Previous hypersensitivity reaction to rifampicin 2. The patient is receiving a concomitant medication with an expected clinically significant drug interaction with rifampicin, which cannot be ceased, substituted for an alternative agent, or mitigated by dose adjustment. 3. One or more causative Gram-positive organisms of interest have in-vitro evidence of resistance to rifampicin 4. Known pregnancy or breastfeeding 5. Treating team deems enrolment in this domain is not in the best interests of the patient. Antibiotic Duration Part A Domain inclusion criteria 1. A single stage revision procedure has been performed For the purposes of this domain, the definition of a single stage revision procedure is as follows: A one-stage revision means: โ€ข Arthrotomy โ€ข Removal of all prosthetic components โ€ข Comprehensive synovectomy โ€ข Placement of "definitive" new components * could be primary or revision components โ€ข With no plans for a second stage operation Additional recommended elements (not part of definition, but considered 'ideal' elements of this procedure): * Removal of all loose cement; well-fixed cement may be retained. * Double set up (using a separate set of sterile instruments and drapes for the reimplantation) Antibiotic Duration Part A Domain exclusion criteria Patients will be excluded from this domain if, at the time of eligibility assessment, they have any of the following: <!-- --> 1. Any causative organism is a fungus or a 'difficult-to-treat' bacterium at the time of platform entry 2. Treating team deems enrolment in this domain is not in the best interests of the patient 3. The single stage revision was \>7 days ago 4. Patient no longer willing to participate in the domain Antibiotic Duration Part B Domain Eligibility assessment and allocation reveal will be performed at day 7 (+/- 3 days) from the time of the reimplantation operation - i.e. between 4 and 10 days following the reimplantation operation. The purpose of this time frame is to confirmation of negative reimplantation cultures. Antibiotic Duration Part B Domain inclusion criteria 1. A two-stage revision procedure has been performed For the purposes of this domain, the definition of two-stage revision and reimplantation procedures are defined as follows: A two-stage revision means: โ€ข Removal of all existing prosthetic components (including metal, ceramic, polyethylene) and any loose cement * Placement of a temporary prost
๐Ÿ’Š

What it tests

  • Debridement and Implant Retention (DAIR)
  • Antibiotic Choice
  • Antibiotic duration Part A - Single stage revision
  • Antibiotic Duration Part B - Two stage revision
๐Ÿ“

Where

43 sites
The Canberra Hospital
Garran, Australia
Bankstown- Lidcombe Hospital
Bankstown, Australia
Blacktown Hospital
Blacktown, Australia
Campbelltown Hospital
Campbelltown, Australia
Royal Prince Alfred Hospital
Camperdown, Australia
Sutherland Hospital
Caringbah, Australia
Ramsay Research C/O Lake Macquarie Private Hospital
Gateshead, Australia
Nepean Hospital
Kingswood, Australia

โ€ฆand 35 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy