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

NCT07053943 | Enrolling By Invitation

• 1 other identifier: WO 25.069
• Study Type: observational
• Target: 70,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Antibiotic Prophylaxis; Total Knee Arthroplasty; Total hip Arthroplasty; revision Arthroplasty

Outcome Measures

Primary Outcomes (3)

• The percentage of hospitals that adopt to the new guideline and the time these hospitals take to do so.

  2 years

• The relative amount of revisions surgeries due to infection reported in the LROI and retrieved with CTcue, compared in the periode one year before implementation of the new guideline and one year after implementation of the new guideline.

  2 years

• The cost per antibiotic dose and the costs related to the extended hospital admission, compared between single-dose and multi-dose perioperative antibiotic prophylaxis.

  2 years

Study Arms (4)

Single-dose antibiotic prophylaxis in Total Hip Arthroplasty

All patients undergoing Total Hip Arthroplasty before the guideline advocating for a multiple dose antibiotic regime.

Single-dose antibiotic prophylaxis in Total Knee Arthroplasty

All patients undergoing Total Knee Arthroplasty before the guideline advocating for a multiple dose antibiotic regime.

Multi-dose antibiotic prophylaxis in Total Hip Arthroplasty

All patients undergoing Total Hip Arthroplasty after the guideline advocating for a multiple dose antibiotic regime.

Multi-dose antibiotic prophylaxis in Total Knee Arthroplasty

All patients undergoing Total Hip Arthroplasty after the guideline advocating for a multiple dose antibiotic regime.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients undergoing Total Hip Arthroplasty and Total Knee Arthroplasty

You may qualify if:

• \- Patients undergoing primary Total Hip Arthroplasty or primary Total Knee Arthroplasty

You may not qualify if:

• \- Patients undergoing Revision Hip Arthroplasty or Revision Knee arhtroplasty

Sponsors & Collaborators

• JointResearch: lead
• Dutch Arthroplasty Register (LROI): collaborator

Study Sites (1)

OLVG Hospital

Amsterdam, North Holland, 1091AC, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 8, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)