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Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip (CONCENTRATE)

R

Radboud University Medical Center

Status and phase

Not yet enrolling
Phase 4

Conditions

PJI
Bone and Joint Infection
Pharmacokinetics

Treatments

Drug: Sampling bone tissue
Drug: sampling blood
Drug: Sampling synovial fluid

Study type

Interventional

Funder types

Other

Identifiers

NCT05421312
2022-13583

Details and patient eligibility

About

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 arthroplasty. In this study, the penetration of antibiotic agents into the synovial fluid and bone will be analyzed. The concentration of antibiotics will be related tot the to the susceptibility (minimal inhibitory concentration; MIC-90) of microorganisms that frequently cause PJI.

Full 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 surgery involving a prosthesis, the administration of systemic antibiotic prophylaxis is strongly recommended to prevent PJI. Cefazolin is widely used as agent of choice in surgical antibiotic prophylaxis. Previous studies, all performed in patients undergoing primary joint replacement, demonstrated that the concentration of cefazolin in bone and synovial fluid was dose-dependent and exceeds the MIC90 for methicillin susceptible Staphylococcus aureus (MSSA), when given as 1 to 4 gram single dose shortly before incision. When a PJI is already present, clindamycin is used as treatment option in PJI caused by staphylococci (when combined with rifampicin) or cutibacteria. A limited number of studies have been performed to analyse the penetration of clindamycin into bone. These studies showed that clindamycin penetrates well into the bone and concentrations exceeded the MIC90 for MSSA. No studies have been performed to analyse the penetration of antibiotic agents into the periarticular tissue in patients who will undergo revision arthroplasty. In revision arthroplasty a foreign body (prosthesis) is in situ and periarticular tissue condition can be compromised due to previous surgical procedures and the presence of bone reaction to the prosthesis. It is not known whether the difference in PJI incidence after primary and revision arthroplasty may be explained by different penetration of the surgical antibiotic prophylaxis. The aim of this explorative study is to analyse the penetration of cefazolin and clindamycin into synovial fluid and bone and whether the concentration of the agents exceeds the MIC90 for micro-organisms frequently causing PJI.

Enrollment

30 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age 16 years or older.
  2. 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 criteria

  1. Antibiotic prophylaxis other than cefazolin 2000mg i.v.
  2. Cefazolin use within 4 days previous to the reimplantation, other than the single dose administration of surgical prophylaxis just before incision.
  3. Clindamycin loaded bone cement in situ.
  4. BMI more than 35 kg/m2.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

cefazolin
Other group
Description:
The cefazolin antimicrobial prophylaxis (2000mg single dose intravenously 15-60 minutes before incision) is part of standard of care.
Treatment:
Drug: Sampling synovial fluid
Drug: Sampling bone tissue
Drug: sampling blood
Clindamycin
Other group
Description:
The clindamycin (600mg three times daily orally) PJI therapy is part of standard care.
Treatment:
Drug: Sampling synovial fluid
Drug: Sampling bone tissue
Drug: sampling blood

Trial contacts and locations

0

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Central trial contact

Karin Veerman, MD

Data sourced from clinicaltrials.gov

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