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A Second Trial of the Abbreviated Protocol Two-Stage Exchange (Apex-2)
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.
Details
| Lead sponsor | Osteal Therapeutics, Inc. |
|---|---|
| Phase | PHASE2 |
| Status | COMPLETED |
| Enrolment | 76 |
| Start date | Mon Jan 23 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Prosthetic-joint Infection
Interventions
- VT-X7 Treatment System
- Two-stage exchange arthroplasty
- SOC Antibiotics
- Experimental Antibiotics
Countries
United States