Antibiotic Loaded Cement After TKA

Sponsor

Rothman Institute Orthopaedics (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05429671

Collaborator

(none)

Enrollment

Location

Arms

12.3

Anticipated Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Arthoplasty	Procedure: total knee arthroplasty Drug: Tobramycin Drug: Gentamicin Device: Antibiotic cement spacer	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 20, 2022

Anticipated Primary Completion Date :

Jun 20, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A (Control-negative group) include participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement containing no antibiotic	Procedure: total knee arthroplasty Participants will have total knee arthroplasty
Active Comparator: Group B (tobramycin group) includes participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement with tobramycin antibiotic.	Procedure: total knee arthroplasty Participants will have total knee arthroplasty Drug: Tobramycin Total knee arthroplasty using Stryker Surgical Simplex P with tobramycin
Active Comparator: Group C (gentamicin group) Include participants undergoing total knee arthroplasty with Huraeus Palacos R+G cement containing gentamicin antibiotic.	Procedure: total knee arthroplasty Participants will have total knee arthroplasty Drug: Gentamicin Total knee arthroplasty using Huraeus Palacos R+G cement containing gentamicin
Active Comparator: 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	Procedure: total knee arthroplasty Participants will have total knee arthroplasty Device: Antibiotic cement spacer participants getting an antibiotic-loaded cement spacer during surgery comprised of vancomycin and tobramycin.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

Rothman Institute Orthopaedics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rothman Institute Orthopaedics

ClinicalTrials.gov Identifier:

NCT05429671

Other Study ID Numbers:

MAUS21D.1213

First Posted:

Jun 23, 2022

Last Update Posted:

Jun 23, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Anti-Bacterial Agents

Gentamicins

Tobramycin

Study Results

No Results Posted as of Jun 23, 2022