Antibiotic Loaded Cement After TKA

NCT05429671 | Completed Phase 3 FDA Drug

• 1 other identifier: MAUS21D.1213
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthoplasty

Outcome Measures

Primary Outcomes (1)

• Antibiotic concentration

  To determine antibiotic levels, synovial fluid (joint fluid) would be taken after surgery to measure the concentration of antibiotic in the joint fluid

  24 hours

Study Arms (4)

Group A (Control-negative group)

ACTIVE COMPARATOR

include participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement containing no antibiotic

Procedure: total knee arthroplasty

Group B (tobramycin group)

ACTIVE COMPARATOR

includes participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement with tobramycin antibiotic.

Procedure: total knee arthroplasty; Drug: Tobramycin

Group C (gentamicin group)

ACTIVE COMPARATOR

Include participants undergoing total knee arthroplasty with Huraeus Palacos R+G cement containing gentamicin antibiotic.

Procedure: total knee arthroplasty; Drug: Gentamicin

Group D (Control-positive group)

ACTIVE COMPARATOR

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

Procedure: total knee arthroplasty; Device: Antibiotic cement spacer

Interventions

total knee arthroplasty PROCEDURE

Participants will have total knee arthroplasty

Group A (Control-negative group); Group B (tobramycin group); Group C (gentamicin group); Group D (Control-positive group)

Tobramycin DRUG

Total knee arthroplasty using Stryker Surgical Simplex P with tobramycin

Group B (tobramycin group)

Gentamicin DRUG

Total knee arthroplasty using Huraeus Palacos R+G cement containing gentamicin

Group C (gentamicin group)

Antibiotic cement spacer DEVICE

participants getting an antibiotic-loaded cement spacer during surgery comprised of vancomycin and tobramycin.

Group D (Control-positive group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee; Tobramycin; Gentamicins

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 23, 2022
• Study Start: June 20, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Locations

US (1)