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Experimental for Prosthetic Joint Infections (APEX Trial)

Phase 2
Waitlist Available
Led By Bryan Springer, MD
Research Sponsored by Osteal Therapeutics, Inc.
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 365 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is a multi-site, parallel group, randomized trial. The objective is to evaluate safety and determine preliminary efficacy of VT-X7. Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 90 days.

Eligible Conditions
  • Prosthetic Joint Infections

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~365 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite endpoint of Overall Success at 90 days
Secondary study objectives
Composite endpoint of Overall Success at 180 days
Composite endpoint of Overall Success at 365 days consisting of

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment3 Interventions
Local antibiotic irrigation via the VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days) Treatment System adjuvant to two-stage exchange arthroplasty per standard of care.
Group II: ControlActive Control2 Interventions
Standard of care for treatment of chronic PJI - two-stage exchange arthroplasty: surgical removal of the infected implant, aggressive debridement, and exchange arthroplasty with administration of adjuvant systemic antibiotics and temporary antibiotic-impregnated cement spacer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Two-stage exchange arthroplasty
2021
Completed Phase 2
~80
VT-X7 Treatment System with Vancomycin Hydrochloride
2021
Completed Phase 2
~80
VT-X7 Treatment System with Tobramycin Sulfate
2021
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Osteal Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
91 Total Patients Enrolled
1 Trials studying Prosthetic Joint Infections
15 Patients Enrolled for Prosthetic Joint Infections
Bryan Springer, MDPrincipal InvestigatorOrtho Carolina
2 Previous Clinical Trials
41 Total Patients Enrolled
1 Trials studying Prosthetic Joint Infections
15 Patients Enrolled for Prosthetic Joint Infections
~19 spots leftby Nov 2025
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