Status:
UNKNOWN
Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Sint Maartenskliniek
Conditions:
PJI
Bone and Joint Infection
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
To prevent periprosthetic joint infection (PJI), optimal penetration of antibiotics into the joint-space is needed. In revision arthroplasty, the incidence of PJI is increased compared to primary arth...
Detailed Description
Periprosthetic joint infection (PJI) is a feared complication of joint replacement, with an incidence of 0.5-1% after primary joint replacement and 3-5% after revision arthroplasty. For orthopaedic su...
Eligibility Criteria
Inclusion
- Age 16 years or older.
- Scheduled second stage revision arthroplasty (reimplantation) of the hip prosthesis during clindamycin 600mg three times a day orally for PJI, started at least 3 days before reimplantation (steady state).
Exclusion
- Antibiotic prophylaxis other than cefazolin 2000mg i.v.
- Cefazolin use within 4 days previous to the reimplantation, other than the single dose administration of surgical prophylaxis just before incision.
- Clindamycin loaded bone cement in situ.
- BMI more than 35 kg/m2.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05421312
Start Date
September 1 2022
End Date
December 1 2023
Last Update
June 16 2022
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