Early Periprosthetic Joint Infection and Outcome Debridement, Antibiotics and Implant Retention

Infection Clinical Trial

— DAIR  

Official title:

Early Periprosthetic Joint Infection and Debridement, Antibiotics and Implant Retention in Arthroplasty for Femoral Neck Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02771639
• Other study ID #: DAIR_SM
• Status: Completed
• Phase: N/A
• First received: May 8, 2016
• Last updated: May 12, 2016
• Start date: January 2016
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Sundsvall Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

Introduction Periprosthetic joint infection (PJI) is a severe complication to hip arthroplasty for femoral neck fractures (FNF). Debridement, antibiotics and implant retention (DAIR) is recommended in early PJI in association with stable implants. Few studies have evaluated the outcome of DAIR in this fragile population.The purpose of this study was to analyze risk factors for PJI and the short-term outcome of DAIR in FNF patients treated with a hip arthroplasty.

Methods A consecutive series of patients had been treated with either a total hip arthroplasty or a hemi hip arthroplasty for a displaced FNF at our institution. Data were retrospective analysed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 736
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Displaced femoral neck fracture

• Treated with a primary hip arthroplasty

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Communicable Diseases
• Femoral Neck Fracture
• Femoral Neck Fractures
• Infection

Intervention

Procedure:
• Hip arthroplasty
Treatment with a hip arthroplasty (semi- or total hip arthroplasty) for a displaced femoral neck fracture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sundsvall Hospital

References & Publications (5)

Dale H, Fenstad AM, Hallan G, Havelin LI, Furnes O, Overgaard S, Pedersen AB, Kärrholm J, Garellick G, Pulkkinen P, Eskelinen A, Mäkelä K, Engesæter LB. Increasing risk of prosthetic joint infection after total hip arthroplasty. Acta Orthop. 2012 Oct;83(5):449-58. doi: 10.3109/17453674.2012.733918. — View Citation

Edwards C, Counsell A, Boulton C, Moran CG. Early infection after hip fracture surgery: risk factors, costs and outcome. J Bone Joint Surg Br. 2008 Jun;90(6):770-7. doi: 10.1302/0301-620X.90B6.20194. — View Citation

Fisman DN, Reilly DT, Karchmer AW, Goldie SJ. Clinical effectiveness and cost-effectiveness of 2 management strategies for infected total hip arthroplasty in the elderly. Clin Infect Dis. 2001 Feb 1;32(3):419-30. Epub 2001 Jan 26. — View Citation

Noailles T, Brulefert K, Chalopin A, Longis PM, Gouin F. What are the risk factors for post-operative infection after hip hemiarthroplasty? Systematic review of literature. Int Orthop. 2015 Nov 27. [Epub ahead of print] — View Citation

Osmon DR, Berbari EF, Berendt AR, Lew D, Zimmerli W, Steckelberg JM, Rao N, Hanssen A, Wilson WR; Infectious Diseases Society of America. Executive summary: diagnosis and management of prosthetic joint infection: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2013 Jan;56(1):1-10. doi: 10.1093/cid/cis966. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of periprosthetic joint infection	The incidence of periprosthetic joint infection	1 year	No
Secondary	The rate of healed periprosthetic joint infections after treatment with surgical debridement.	The rate of healed periprosthetic joint infections after treatment with surgical debridement.	6 months	No