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Group D (Control-positive group) for Total Knee Replacement

Phase 3
Waitlist Available
Research Sponsored by Rothman Institute Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights

Study Summary

This trial will help surgeons determine if antibiotic-loaded bone cement can prevent growth of common infecting microorganisms, and if it is cost-effective in preventing PJI.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Antibiotic concentration

Trial Design

4Treatment groups
Active Control
Group I: Group D (Control-positive group)Active Control2 Interventions
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 II: Group B (tobramycin group)Active Control2 Interventions
includes participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement with tobramycin antibiotic.
Group III: Group C (gentamicin group)Active Control2 Interventions
Include participants undergoing total knee arthroplasty with Huraeus Palacos R+G cement containing gentamicin antibiotic.
Group IV: Group A (Control-negative group)Active Control1 Intervention
include participants undergoing total knee arthroplasty with Stryker Surgical Simplex P cement containing no antibiotic

Find a Location

Who is running the clinical trial?

Rothman Institute OrthopaedicsLead Sponsor
121 Previous Clinical Trials
21,498 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the tobramycin group been given FDA approval?

"Group B, which is receiving tobramycin therapy, has been assessed to be a 3 in terms of safety. This Phase 3 trial provides evidence for the efficacy and safety of this group's intervention."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Antibiotic Loaded Cement After TKA
2022. "Antibiotic Loaded Cement After TKA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05429671.
~28 spots leftby Apr 2025
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