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NCT Number: NCT02087020

Debridement, Antibiotics and Implant Retention in Early Periprosthetic Joint Infection: A Retrospective Cohort Study

Introduction: Periprosthetic joint infection (PJI) is a common cause for reoperation after knee and hip arthroplasty surgery. Debridement, antibiotics and implant retention (DAIR) is recommended in early infections (< 4 weeks) and stable implants. Aims: To define the success rate of DAIR in early infections and to identify predictors for success. Material and methods: In a retrospective cohort study we included patients with hip- or knee arthroplasties reoperated for an early PJI at Danderyd Hospital 2007-2012. Logistic regression analysis was used to identify risk factors affecting success rate. Primary outcome variable was the success of the DAIR treatment. Secondary outcome variable vas risk factors for treatment failure.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Danderyd Hospital

Stockholm, Danderyd, 182 88, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients treated with DAIR for early postoperative periprosthetic joint infection after knee- or hip arthroplasty surgery (<4-6 weeks postoperatively) at our institution between 2007-01-01 and 2012-12-01.

Exclusion criteria

Chronic or late presenting periprosthetic joint infection (>6 weeks postoperatively), acute hematogenous periprosthetic joint infection, when the periprosthetic joint infection diagnosis criteria according to American Musculoskeletal Infection Society (MSIS) 2011 definition of PJI definitions were not fulfilled and when the initial surgical treatment was with other treatment protocol than DAIR including one-stage revision and two -stage revision

Treatment and study plan

Debridement, antibiotics and implant retention

Procedure

DAIR treatment protocol embodies an extensive surgical debridement and a radical excision of infected tissue. This is followed by exchange of modular components (articulating surfaces of the implant such as the femoral head, acetabular liner in total hip arthroplasty and the tibial insert, the polyethylene meniscus, in total knee arthroplasty). The wound is then copiously irrigated (> 9 litre) with 0.9 % sodium chloride and then closed.

Primary outcomes

  1. Successful treatment

    Time frame: 6 year

    The success rate, in terms of infection eradication without additional surgical methods, of debridement, antibiotics and implant retention in early postoperative periprosthetic joint infection..

Secondary outcomes

  1. Risk factors for treatment failure

    Time frame: 6 year

    Analyze of potential risk factors for treatment failure, age, gender, comorbidities i.e type 1 or 2 diabetes mellitus, renal insufficiency, dementia, systemic inflammatory disease, local or systemic infection, American Society of Anesthesiologists classification, virulence of infecting microbial, hospital stay, typ of arthroplasty, revision arthroplasty, and administration of antibiotics prior to debridement, antibiotics and implant retention treatment.

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Registry information

Acronym: DAIR

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 14, 2014
Registry last updated
Mar 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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