Evaluation of the Safety of Prophylactic Intraosseous Antibiotic Administration in Knee Arthroplasty

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031250802

Enrollment

Registered

2026-03-12

Start date

2026-05-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the knee Osteoarthritis of the knee

Interventions

For patients with osteoarthritis of the knee undergoing knee arthroplasty, cefazolin sodium will be administered intraosseously immediately before surgery.

Intraosseous administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with osteoarthritis of the knee and scheduled to undergo knee arthroplasty (2) Patients scheduled to receive cefazolin sodium as perioperative prophylactic antibiotic administration (3) Age: Patients aged >= 18 and <= 85 at the time of obtaining informed consent (4) Sex: Not specified (5) Patients who provided written informed consent of their own free will after receiving sufficient explanation and achieving a full understanding regarding participation in this study

Exclusion criteria

Exclusion criteria: (1) Patients with a history of surgery on the knee scheduled for surgery (2) Patients receiving antibiotics other than cefazolin sodium simultaneously (3) Patients with a history of hypersensitivity to cephem or penicillin antibiotics (4) Patients with renal dysfunction (eGFR < 30) (5) Other patients judged unsuitable for participation in this study by the principal investigator or sub-investigator Osteoarthritis of the knee

Design outcomes

Primary

Measure	Time frame
Frequency of composite events (surgical site infection, acute kidney injury, or Clostridium difficile enteritis) occurring during the perioperative period	—

Secondary

Measure	Time frame
(1) Frequency of surgical site infection occurring during the perioperative period (2) Frequency of acute kidney injury occurring during the perioperative period (3) Frequency of Clostridium difficile enteritis occurring during the perioperative period (4) Frequency of adverse events related to the intraosseous administration procedure occurring during study drug administration (5) Frequency of adverse events (other than surgical site infection, acute kidney injury, or Clostridium difficile enteritis)	—

Measure

Time frame

(1) Frequency of surgical site infection occurring during the perioperative period (2) Frequency of acute kidney injury occurring during the perioperative period (3) Frequency of Clostridium difficile enteritis occurring during the perioperative period (4) Frequency of adverse events related to the intraosseous administration procedure occurring during study drug administration (5) Frequency of adverse events (other than surgical site infection, acute kidney injury, or Clostridium difficile enteritis)

—

Contacts

Public ContactKohei Kawaguchi

The University of Tokyo Hospital

kkohei0602@yahoo.co.jp+81-338155411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026