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

Direct Infection of Hip- and Knee Arthroplasty Clinical Trial

— DAIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02087020
• Other study ID #: DAIR-3
• Status: Completed
• Phase: N/A
• First received: March 6, 2014
• Last updated: March 8, 2014
• Start date: January 2013
• Est. completion date: June 2013

Study information

• Verified date: March 2014
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Communicable Diseases
• Direct Infection of Hip- and Knee Arthroplasty
• Infection

Intervention

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.

Locations

Country	Name	City	State
Sweden	Danderyd Hospital	Stockholm	Danderyd

Sponsors (1)

Lead Sponsor	Collaborator
Danderyd Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections. N Engl J Med. 2004 Oct 14;351(16):1645-54. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful treatment	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	No
Secondary	Risk factors for treatment failure	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	No