Infection-related Revision Rates After Single-dose Versus Multiple-dose Antibiotic Prophylaxis in Primary Hip and Knee Arthroplasty: a Comparative Implementation Study.

Sponsor
JointResearch
Study ID
NCT07053943
Status
Enrolling By Invitation

Conditions

  • Antibiotic Prophylaxis
  • Revision Arthroplasty
  • Total Hip Arthroplasty (THA)
  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

Prosthetic Joint Infection (PJI) is a significant issue in joint replacement surgeries, causing additional surgeries and substantial healthcare costs. An effective way of preventing these infections is through the use of antibiotics before and after surgery. However, there is ongoing debate regarding the optimal dosage regimen for these antibiotics to achieve maximum effectiveness. In the Netherlands, most hospitals currently give multiple doses of antibiotics for hip and knee replacement surgeries. A new upcoming guideline recommends using only one dose of antibiotics, which could have several benefits. It might reduce the need for antibiotics overall, decrease the work for nurses, and shorten hospital stays. However, it is unclear if this change is safe or effective. This study aims to compare the effectiveness of the current multi-dose antibiotic method with the new single-dose approach. We will also look at how well hospitals adopt this new guideline (implementation) and compare the healthcare costs associated with both antibiotic regimens. By studying real-world data from surgeries and patient records, we want to determine if the single-dose strategy is as effective at preventing infections and reducing the need for additional surgeries.

Key Dates

First listed
Jul 8, 2025
Start date
Jun 1, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
70,000 participants (estimated)

Arms

  • Arm: Single-dose antibiotic prophylaxis in Total Hip Arthroplasty
    All patients undergoing Total Hip Arthroplasty before the guideline advocating for a multiple dose antibiotic regime.
  • Arm: Single-dose antibiotic prophylaxis in Total Knee Arthroplasty
    All patients undergoing Total Knee Arthroplasty before the guideline advocating for a multiple dose antibiotic regime.
  • Arm: Multi-dose antibiotic prophylaxis in Total Hip Arthroplasty
    All patients undergoing Total Hip Arthroplasty after the guideline advocating for a multiple dose antibiotic regime.
  • Arm: Multi-dose antibiotic prophylaxis in Total Knee Arthroplasty
    All patients undergoing Total Hip Arthroplasty after the guideline advocating for a multiple dose antibiotic regime.

Primary Outcome Measure

The percentage of hospitals that adopt to the new guideline and the time these hospitals take to do so. [ Time Frame: 2 years ]

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