Antibiotic Loaded Cement After TKA

Phase 3

Completed

• Conditions: Total Knee Arthoplasty
• Interventions: Procedure: total knee arthroplasty; Device: Antibiotic cement spacer; Drug: Tobramycin; Drug: Gentamicin

• Registration Number: NCT05429671
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

This study will provide us with clear information about the postoperative concentration of antibiotic reached in synovial fluid, thereby helping surgeons to determine if concentration could potentially prevent the growth and regrowth of common infecting microorganisms (based on their MIC and MBEC). There is a need to define the actual benefit of antibiotic-loaded bone cement, because the addition of antibiotic can reduce its mechanical strength. Moreover, if sub-therapeutic antibiotic levels are achieved, this could facilitate the emergence of resistant bacterial strains. Amidst the transition towards value-based care, our research will enable surgeons to decide whether antibiotic-loaded cement is truly cost-effective in the prevention of PJI.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-17
• Study Start: 2022-06-20
• Study First Posted: 2022-06-23
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-29
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• All participants undergoing cemented primary total knee arthroplasty (TKA) who are 18 years or older.

Exclusion Criteria

• Withdrawal of informed consent,
• allergy to any of the study medications or to bone cement,
• use of antibiotics within 4 weeks before collecting the samples (not including perioperative antimicrobial prophylaxis),
• high risk of infection,
• history of peri-articular injections for multimodal pain management.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (Control-negative group)	total knee arthroplasty	include participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement containing no antibiotic
Group C (gentamicin group)	total knee arthroplasty	Include participants undergoing total knee arthroplasty with Huraeus Palacos R+G cement containing gentamicin antibiotic.
Group D (Control-positive group)	total knee arthroplasty	Include participants undergoing the first of a two-stage exchange arthroplasty for confirmed infection, using an antibiotic-loaded cement spacer. These patients will have a spacer implant made of vancomycin and tobramycin antibiotics using Huraeus Palacos non-antibiotic loaded cement
Group D (Control-positive group)	Antibiotic cement spacer	Include participants undergoing the first of a two-stage exchange arthroplasty for confirmed infection, using an antibiotic-loaded cement spacer. These patients will have a spacer implant made of vancomycin and tobramycin antibiotics using Huraeus Palacos non-antibiotic loaded cement
Group B (tobramycin group)	total knee arthroplasty	includes participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement with tobramycin antibiotic.
Group B (tobramycin group)	Tobramycin	includes participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement with tobramycin antibiotic.
Group C (gentamicin group)	Gentamicin	Include participants undergoing total knee arthroplasty with Huraeus Palacos R+G cement containing gentamicin antibiotic.

Primary Outcome Measures

Name	Time	Method
Antibiotic concentration	24 hours	To determine antibiotic levels, synovial fluid (joint fluid) would be taken after surgery to measure the concentration of antibiotic in the joint fluid

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States