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Two-stage Arthroplasty for the Septic Arthritis of the Native Knee Joint

NCT05484284 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-08-02

No results posted yet for this study

Summary

Septic arthritis (SA) of the native knee joint is rare but difficult to manage. Open or arthroscopic debridement is currently the most widely used approach. The problem is that there is a 71% and 50% chance of requiring revision surgery, respectively. Patients with recurrent sepsis may require arthrodesis or amputation, which would result in severe functional loss. Therefore, there is an urgent need to find more effective surgical procedures. Investigators developed a two-stage exchange with low-dose antibiotics for the treatment of SA and evaluated its efficacy.

Conditions

  • Septic Arthritis

Interventions

PROCEDURE

two-stage primary total knee arthroplasty with low-dose antibiotics

Briefly, investigators completely debrided all necrotic soft tissue in the first stage of the operation. The surgical site was flushed twice with hydrogen peroxide, iodine, and saline solutions. Then, the antibiotic-loaded cement spacer was inserted. After surgery, a 10-day course of intravenous organism-specific antibiotics or vancomycin was administered, followed by oral antibiotic therapy. Second-stage reimplantation was performed once there was no sign of infection. The spacer was removed and the new prosthesis was implanted without the use of antibiotic-containing bone cement.

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Lan Tang, MD · 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-22
Primary Completion
2022-04-06
Completion
2022-04-22

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05484284 on ClinicalTrials.gov