None listed
Conditions
Brief summary
There is currently a lack of high quality evidence to inform the management of prosthetic joint infections (PJI), an uncommon, but potentially devastating complication of joint replacement surgery. Prosthetic Joint Infection in Australia and New Zealand Observational Study (PIANO) is a multicentre, prospective observational study of prosthetic joint infections in Australia and New Zealand. The study aims to describe the clinical, laboratory, microbiological and radiological features of patients presenting with prosthetic joint infections and their management and subsequent outcomes.
Interventions
The objective of the PIANO study is to describe prospectively in detail the clinical, laboratory, microbiological and radiological features, economic costs for patients presenting with prothetic joint infection and treatment outcomes in terms of initial treatment strategy, surgical methods, choice and duration of antibiotic therapy and micro-organism (duration of 5.75 years in total, May 2014-Dec 2019).
Sponsors
Australasian Society for Infectious Diseases Clinical Research Network
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a. Age at least 18 years b. Prosthetic Joint infection diagnosed according to infection clinically suspected by an infectious diseases specialist or orthopaedic surgeon, AND presence of at least one of: i. Presence of sinus tract communicating with the prosthesis ii. Increased leukocyte count or neutrophil percentage in preoperative synovial fluid aspirate (synovial fluid white blood cell count over 1700 cells/microlitre or neutrophil percentage greater than 65%). iii. Visible pus around the prosthesis at operation without alternative explanation iv. Acute inflammation as reported by the clinical pathologist on examination of periprosthetic tissue (>=5 or more neutrophils per high power field) v. Two or more pre-operative or intraoperative cultures (blood, synovial fluid, peri-prosthetic tissue, or sonication fluid) that yield the same organism (indistinguishable based on common laboratory tests including genus and species identification or common antibiogram). vi. Pure growth of Staphylococcus aureus, beta-haemolytic streptococci or pathogenic aerobic Gram negative rod from a single synovial fluid or intraoperative tissue/fluid specimen Adapted from Diagnosis and Management of Prosthetic Joint Infection: Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA 2012)15, and Guideline on The Diagnosis of Periprosthetic Joint Infections of the Hip and Knee (AAOS 2010)16 c. The infected joint is one of hip, knee, shoulder, elbow, wrist or ankle d. The infected prosthesis is either a total joint replacement or hemi-arthroplasty. e. The PJI is “current”. This means that there is ongoing active treatment for it at the time of enrollment, and that all data relating to this episode are accessible. For example if the infection was diagnosed at another hospital 3 months ago, and is currently being treated at the recruiting site, then they can be enrolled as long as the data from the original hospital are accessible.
Exclusion criteria
a. Unable to give informed consent b. Infected hardware other than intra-articular prostheses (this includes pins and plates, screws, nails and wires) – unless there is a concomitant intra-articular prosthesis infection. c. Unlikely to be accessible for follow up over next 24 months – any one of: a. Ordinarily lives outside of Australia and New Zealand b. Has no access to landline or mobile telephone d. Relapse of previous infection Since the primary mode of analysis is survival analysis, participants will not be excluded on the basis of being unlikely to survive for any particular period of time.
Outcome results
None listed