76
Participants
Start Date
January 23, 2023
Primary Completion Date
May 20, 2024
Study Completion Date
October 30, 2024
VT-X7 Treatment System
Seven-day local antibiotic irrigation (alternating vancomycin hydrochloride and tobramycin sulfate) via the temporary VT-X7 Knee or Hip Spacer.
Two-stage exchange arthroplasty
Stage 1 consists of surgical removal of the infected prosthesis, debridement, and implantation of a temporary spacer. Stage 2 surgery consists of explantation of the temporary spacer, debridement, and implantation of a permanent prosthesis.
SOC Antibiotics
Administration of at least 6 weeks of systemic antibiotics post-Stage 1 surgery followed by a 2-week antibiotic holiday before the Stage 2 surgery. After Stage 2 surgery, administration of at least 12 weeks of systemic antibiotics. Antibiotics will be selected by the treatment provider based on the infecting organism and administered per national and local treatment guidelines.
Experimental Antibiotics
After Stage 2 surgery, administration of at least 12 weeks of systemic antibiotics. Antibiotics will be selected by the treatment provider based on the infecting organism and administered per national and local treatment guidelines.
NYU Langone Health, New York
University of Pittsburgh Medical Center, Pittsburgh
Rothman Orthopaedic Institute, Philadelphia
University of Virginia Health, Charlottesville
OrthoCarolina, Charlotte
Cleveland Clinic Florida, Weston
Kennedy White Orthopaedic Center, Sarasota
The Ohio State University Medical Center, Columbus
Cleveland Clinic, Cleveland
University of Cincinnati, Cincinnati
Bethesda North Hospital - TriHealth Hatton Research, Cincinnati
Covenant Medical Center, Saginaw
Medical College of Wisconsin, Milwaukee
Mayo Clinic, Rochester
University of Missouri, Columbia
INTEGRIS Health Southwest Medical Center, Oklahoma City
Houston Methodist Medical Center, Houston
Banner - University Medical Center Phoenix, Phoenix
Harbor UCLA Medical Center, Los Angeles
Lead Sponsor
Osteal Therapeutics, Inc.
INDUSTRY