Antibiotic Loaded Cement After TKA

Drug Elution Profile and Minimum Inhibitory Concentration of Antibiotic-loaded Cement After Primary Total Knee Arthroplasty

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05429671

Enrollment

Registered

2022-06-23

Start date

2022-06-20

Completion date

2023-11-30

Last updated

2024-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Total Knee Arthoplasty

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.

Interventions

PROCEDUREtotal knee arthroplasty

Participants will have total knee arthroplasty

DRUGTobramycin

Total knee arthroplasty using Stryker Surgical Simplex P with tobramycin

DRUGGentamicin

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

DEVICEAntibiotic cement spacer

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026