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

March 8, 2014 updated by: Olof Skoldenberg, Danderyd Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Danderyd
      • Stockholm, Danderyd, Sweden, 182 88
        • Danderyd Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Danderyd Hospital is a university hospital affiliated with the Karolinska Institute and is one of the four emergency hospitals in Stockholm, with a catchment area of approximately 500.000 inhabitants. The index cohort was extracted from the local in-hospital surgery database at the Department of Orthopaedic Surgery using ICD 10 coding and surgical intervention coding for PJI treatment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Periprosthetic joint infection
Patient treated with 'Debridement, antibiotics and implant retention' for early postoperative periprosthetic joint infection at Danderyd Hospital between 2007-01-01 and 2012-12-01
Procedure: Debridement, antibiotics and implant retention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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..
6 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danderyd Hospital

Investigators

  • Principal Investigator: Olof G Skoldenberg, MD,PhD, Orthopaedic department, Danderyds hospital
  • Study Chair: Sebastian S Mukka, MD, Orthopaedic department, Danderyds hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 6, 2014

First Submitted That Met QC Criteria

March 8, 2014

First Posted (Estimate)

March 14, 2014

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

March 8, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAIR-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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