Intrawound Administration of Vancomycin in THA

Not Applicable

Completed

• Conditions: Hip

• Registration Number: NCT05338008
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

The purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total hip arthroplasty.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-11
• Study First Submitted QC: 2022-04-17
• Study First Posted: 2022-04-20
• Study Start: 2022-05-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-02
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age over 18;
2. Total hip arthroplasty for advanced hip diseases including femoral neck fracture, developmental dysplasia of hip, and osteonecrosis of the femoral head.

Exclusion Criteria

1. Diminished mental capacity
2. Vancomycin allergy
3. Chronic kidney disease stage III and stage IV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood loss	Postoperative Day 3
Renal function	Postoperative Day 1 and Day 3	blood urea nitrogen (BUN), creatinine (Cr), GFR
Intra-articular vancomycin concentration	2 hours, 8 hours and 24 hours postoperatively
Serum vancomycin concentration	2 hours, 8 hours and 24 hours postoperatively

Trial Locations

Locations (1)

The affiliated hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China