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NCT04662632 · ClinicalTrials.gov registry record · Phase 2
Abbreviated Protocol for Two-Stage Exchange
A Phase 2 study, sponsored by Osteal Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT04662632: Completed Phase 2 study, sponsored by Osteal Therapeutics.
NCT04662632 is a Phase 2 study that has completed, run by Osteal Therapeutics. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04662632, a Phase 2 study, has completed, sponsored by Osteal Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study Summary
Study Type: A multi-site, parallel group, randomized trial. Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days). Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Overall Success at 90 days, consisting of a revision prosthesis implanted at Stage 2, patient survival, absence of reoperation and absence of periprosthetic joint infection (PJI). Secondary objectives are to evaluate superiority at 365 days in a composite endpoint of Overall Success, and in separate secondary endpoints for quality of life 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.
Primary Outcome
Composite endpoint of Overall Success at 90 days consisting of: * Stage 2 revision prosthesis implanted; * Absence of PJI\* post-Stage 2; * Absence of reoperation\*\*\* of the affected joint pre- or post- Stage 2; and * Absence of mortality. * If clinical evidence of infection is present post-Stage 2 surgery, use the International Consensus Meeting on Musculoskeletal Infection 2018 guidelines for definitive PJI confirmation. * Reoperation includes only procedures to irrigate, debride, a
Interventions
- DRUG Standard of Care
- PROCEDURE Two-stage exchange arthroplasty
- COMBINATION_PRODUCT VT-X7 Treatment System with Tobramycin Sulfate
- COMBINATION_PRODUCT VT-X7 Treatment System with Vancomycin Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2021-11-01 |
| Est. Completion | 2023-12-22 |
| Phase | Phase 2 |
What the finished NCT04662632 record still lists
NCT04662632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 4 interventions - of which Standard of Care is the first listed.
NCT04662632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04662632 about?
NCT04662632 is a clinical study titled "Abbreviated Protocol for Two-Stage Exchange". Study Type: A multi-site, parallel group, randomized trial. Study Objectives: The objective is to evaluate safety and determine preliminary efficacy of VT-X7 (Vancomycin and Tobramycin Exchanged over 7 Days). Efficacy is evaluated as superiority of the Experimental Arm in a composite endpoint of Ov...
What is the current status of trial NCT04662632?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2021-11-01. Estimated completion is 2023-12-22.
What interventions are being tested in trial NCT04662632?
The interventions under investigation include: Standard of Care (DRUG), Two-stage exchange arthroplasty (PROCEDURE), VT-X7 Treatment System with Tobramycin Sulfate (COMBINATION_PRODUCT), VT-X7 Treatment System with Vancomycin Hydrochloride (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04662632?
This trial is sponsored by Osteal Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04662632's enrollment target sits among peer trials
76 893rd of 2000 higher than 1,101 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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