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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

APEX Trial 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

APEX Trial 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

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

APEX 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
2 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

Frequently Asked Questions

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

Is admission to this medical trial restricted by age, and if so, what is the cutoff?

"The minimum age of entry into this medical trial is 22, while the maximum accepted age is 84."

Answered by AI

Are there opportunities available for people to take part in this research?

"Indeed, the information posted on clinicaltrials.gov affirms that this medical experiment is actively recruiting participants as of October 31st 2022. It was initially uploaded to the website on November 1st 2021 and 76 individuals are needed from 23 different sites."

Answered by AI

Who qualifies to participate in this scientific trial?

"This clinical trial is enrolling 76 individuals with prosthetic joint infections, aged between 22 and 84. To gain access to the study, patients must meet a criteria including being scheduled for two-stage exchange arthroplasty due to hip or knee PJI, offering informed consent, medical clearance for surgery, as well as having a preoperative diagnosis of Musculoskeletal Infection per ICMMI 2018 definition standards."

Answered by AI

How widely distributed is this clinical exploration?

"At the moment, 23 different medical sites in Washington, Torrance and Gainesville are enrolling participants into this clinical trial. It is recommended that patients choose their nearest site to minimize travel requirements if they decide to take part."

Answered by AI

What is the overall size of this medical experiment?

"Affirmative. ClinicalTrials.gov reveals that this study is currently seeking participants, with applications first accepted on November 1st 2021 and the most recent update happening October 31st 2022. 76 individuals are needed from 23 distinct medical centres for trial participation."

Answered by AI

Has the VT-X7 Treatment System attained official sanction from the FDA?

"Our team at Power have deemed VT-X7 Treatment System a safe intervention, scoring it 2 on the safety scale. This is because there are some data points that support its security profile but no evidence yet of efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Abbreviated Protocol for Two-Stage Exchange
2021. "Abbreviated Protocol for Two-Stage Exchange". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04662632.
~22 spots leftby Apr 2025
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