Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VT-X7 Treatment System | Combination Product | Local antibiotic irrigation via the VT-X7 Treatment System adjuvant to two-stage exchange arthroplasty per standard of care. |
Inclusion Criteria:
Exclusion Criteria:
Adalimumab (Humira) Tocilizumab (Actemra) Etanercept (Enbrel) Anakinra (Kineret) Golimumab (Simponi) Secukinumab (Cosentyx) Infliximab (Remicade) Ustekinumab (Stelara) Abatacept (Orencia) Tofacitinib (Xeljanz) Belimumab (Benlysta)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner - University Medical Center Phoenix | Phoenix | Arizona | 85006 | United States | ||
| Cedars-Sinai Medical Center |
Not provided
| Los Angeles |
| California |
| 90048 |
| United States |
| St. Mary's Regional Hospital - Intermountain Health | Grand Junction | Colorado | 81501 | United States |
| University of Florida Health | Gainesville | Florida | 32608 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| Parkview Hospital Orthopedics | Fort Wayne | Indiana | 46845 | United States |
| University of Iowa | North Liberty | Iowa | 52317 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| University of Missouri Health Care | Columbia | Missouri | 65212 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267-0212 | United States |
| Ohio State University | Columbus | Ohio | 43202 | United States |
| Integris Southwest Medical Center | Oklahoma City | Oklahoma | 73109 | United States |
| Houston Methodist Medical Center | Houston | Texas | 77030 | United States |