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NCT05607030 · ClinicalTrials.gov registry record · Phase 2
A Second Trial of the Abbreviated Protocol Two-Stage Exchange
A Phase 2 study of Prosthetic-joint Infection, sponsored by Osteal Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
- 19
- Study locations
NCT05607030 is a Phase 2 study of Prosthetic-joint Infection that has completed, run by Osteal Therapeutics. The registered enrollment target is 76 participants, below the 90-participant average among 9 other Prosthetic-joint Infection trials with a reported enrollment target (16% lower). The trial reports 19 study locations across 14 states.
The verdict
NCT05607030, a Phase 2 study of Prosthetic-joint Infection, has completed, sponsored by Osteal Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
- 19
- Study locations
Study Summary
Apex-2 is a multi-site, parallel group, randomized trial. Patients will be randomly assigned in a 1:1 ratio to the Experimental Arm or the Control Arm. The objective of the study is to evaluate safety and determine efficacy of the VT-X7 system. Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 180 days, consisting of a revision prosthesis implanted at Stage 2, absence of periprosthetic joint infection (PJI), absence of continued antibiotic therapy for treatment or prophylaxis of PJI, absence of revision surgery and absence of mortality. Secondary objectives are to evaluate overall success at 365 days, overall safety of the VT-X7 procedure, quality of life (QoL), and patient survival. The exploratory objective is to compare Experimental and Control Arms in exploratory endpoints. Follow-up: Patients will be evaluated at 90-, 180-, and 365-day follow-up visits.
Conditions Studied
Interventions
- COMBINATION_PRODUCT VT-X7 Treatment System
- PROCEDURE Two-stage exchange arthroplasty
- DRUG SOC Antibiotics
- DRUG Experimental Antibiotics
Study Locations (19)
Ohio
- University of Cincinnati - Cincinnati
- Bethesda North Hospital - TriHealth Hatton Research - Cincinnati
- Cleveland Clinic - Cleveland
- The Ohio State University Medical Center - Columbus
Florida
- Kennedy White Orthopaedic Center - Sarasota
- Cleveland Clinic Florida - Weston
Pennsylvania
- Rothman Orthopaedic Institute - Philadelphia
- University of Pittsburgh Medical Center - Pittsburgh
Arizona
- Banner - University Medical Center Phoenix - Phoenix
California
- Harbor UCLA Medical Center - Los Angeles
Michigan
- Covenant Medical Center - Saginaw
Minnesota
- Mayo Clinic - Rochester
Missouri
- University of Missouri - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2023-01-23 |
| Est. Completion | 2024-10-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05607030
The ClinicalTrials.gov registry entry for NCT05607030 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 90-participant average among 9 other Prosthetic-joint Infection trials with a reported enrollment target (16% lower). The listed sponsor is Osteal Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prosthetic-joint Infection appearing as the primary indexed condition, and to 4 interventions - of which VT-X7 Treatment System is the first listed.
NCT05607030 reports 19 study locations spanning 14 distinct geographic areas - top geographies include Ohio, Florida, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05607030 about?
NCT05607030 is a clinical study titled "A Second Trial of the Abbreviated Protocol Two-Stage Exchange". Apex-2 is a multi-site, parallel group, randomized trial. Patients will be randomly assigned in a 1:1 ratio to the Experimental Arm or the Control Arm. The objective of the study is to evaluate safety and determine efficacy of the VT-X7 system. Efficacy is evaluated as superiority of the Experiment...
What is the current status of trial NCT05607030?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2023-01-23. Estimated completion is 2024-10-30.
What conditions does trial NCT05607030 study?
This clinical trial studies the following conditions: Prosthetic-joint Infection.
What interventions are being tested in trial NCT05607030?
The interventions under investigation include: VT-X7 Treatment System (COMBINATION_PRODUCT), Two-stage exchange arthroplasty (PROCEDURE), SOC Antibiotics (DRUG), Experimental Antibiotics (DRUG).
Who is sponsoring clinical trial NCT05607030?
This trial is sponsored by Osteal Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05607030 being conducted?
This trial has 19 study locations across Arizona, California, Florida, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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