Antibiotic Loaded Cement After TKA

Rothman Institute Orthopaedics

Status and phase: Completed; Phase 3

Conditions: Total Knee Arthoplasty

Treatments: Device: Antibiotic cement spacer; Procedure: total knee arthroplasty; Drug: Gentamicin; Drug: Tobramycin

Study type: Interventional

Funder types: Other

Identifiers

NCT05429671

MAUS21D.1213

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

Group A (Control-negative group)

Active Comparator group

Description:

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

Treatment:

Procedure: total knee arthroplasty

Group B (tobramycin group)

Active Comparator group

Description:

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

Treatment:

Procedure: total knee arthroplasty

Drug: Tobramycin

Group C (gentamicin group)

Active Comparator group

Description:

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

Treatment:

Procedure: total knee arthroplasty

Drug: Gentamicin

Group D (Control-positive group)

Active Comparator group

Description:

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

Treatment:

Device: Antibiotic cement spacer

Procedure: total knee arthroplasty