Trials / Temporarily Not Available
Temporarily Not AvailableNCT06383611
Expanded Access to Cyclic Irrigation in Patients Undergoing Exchange Arthroplasty
Protocol for Expanded Access to Cyclic Irrigation of Vancomycin Hydrochloride and Tobramycin Sulfate in Patients Undergoing Exchange Arthroplasty for Periprosthetic Joint Infection of the Hip or Knee
- Status
- Temporarily Not Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- Osteal Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 22 Years – 84 Years
- Healthy volunteers
- —
Summary
The objective of the protocol is to provide access to the VT-X7 (Vancomycin, Tobramycin Exchanged in 7 Days) system for subjects with periprosthetic joint infection (PJI) of the hip or knee who lack therapeutic treatment alternatives.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | VT-X7 Treatment System | Local antibiotic irrigation via the VT-X7 Treatment System adjuvant to two-stage exchange arthroplasty per standard of care. |
Timeline
- First posted
- 2024-04-25
- Last updated
- 2026-04-15
Locations
14 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06383611. Inclusion in this directory is not an endorsement.