Antibiotic Loaded Cement After TKA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-20

Study Completion Date

2023-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Total Knee Arthoplasty

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A (Control-negative group)

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

Group Type ACTIVE_COMPARATOR

total knee arthroplasty

Intervention Type PROCEDURE

Participants will have total knee arthroplasty

Group B (tobramycin group)

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

Group Type ACTIVE_COMPARATOR

total knee arthroplasty

Intervention Type PROCEDURE

Participants will have total knee arthroplasty

Tobramycin

Intervention Type DRUG

Total knee arthroplasty using Stryker Surgical Simplex P with tobramycin

Group C (gentamicin group)

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

Group Type ACTIVE_COMPARATOR

total knee arthroplasty

Intervention Type PROCEDURE

Participants will have total knee arthroplasty

Gentamicin

Intervention Type DRUG

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

Group D (Control-positive group)

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 Type ACTIVE_COMPARATOR

total knee arthroplasty

Intervention Type PROCEDURE

Participants will have total knee arthroplasty

Antibiotic cement spacer

Intervention Type DEVICE

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

Interventions

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total knee arthroplasty

Participants will have total knee arthroplasty

Intervention Type PROCEDURE

Tobramycin

Total knee arthroplasty using Stryker Surgical Simplex P with tobramycin

Intervention Type DRUG

Gentamicin

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

Intervention Type DRUG

Antibiotic cement spacer

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes