A Second Trial of the Abbreviated Protocol Two-Stage Exchange

PHASE2CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

January 23, 2023

Primary Completion Date

May 20, 2024

Study Completion Date

October 30, 2024

Conditions
Prosthetic-joint Infection
Interventions
COMBINATION_PRODUCT

VT-X7 Treatment System

Seven-day local antibiotic irrigation (alternating vancomycin hydrochloride and tobramycin sulfate) via the temporary VT-X7 Knee or Hip Spacer.

PROCEDURE

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.

DRUG

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.

DRUG

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.

Trial Locations (19)

10016

NYU Langone Health, New York

15213

University of Pittsburgh Medical Center, Pittsburgh

19107

Rothman Orthopaedic Institute, Philadelphia

22903

University of Virginia Health, Charlottesville

28207

OrthoCarolina, Charlotte

33331

Cleveland Clinic Florida, Weston

34232

Kennedy White Orthopaedic Center, Sarasota

43202

The Ohio State University Medical Center, Columbus

44195

Cleveland Clinic, Cleveland

45219

University of Cincinnati, Cincinnati

45242

Bethesda North Hospital - TriHealth Hatton Research, Cincinnati

48602

Covenant Medical Center, Saginaw

53226

Medical College of Wisconsin, Milwaukee

55905

Mayo Clinic, Rochester

65212

University of Missouri, Columbia

73109

INTEGRIS Health Southwest Medical Center, Oklahoma City

77030

Houston Methodist Medical Center, Houston

85006

Banner - University Medical Center Phoenix, Phoenix

90502

Harbor UCLA Medical Center, Los Angeles

Sponsors
All Listed Sponsors
lead

Osteal Therapeutics, Inc.

INDUSTRY

NCT05607030 - A Second Trial of the Abbreviated Protocol Two-Stage Exchange | Biotech Hunter | Biotech Hunter