Copy to clipboard 
Osteal Therapeutics announced positive 12-month results from the two APEX (Abbreviated Protocol for Two Stage Exchange) clinical trials of VT-X7 KIT (vancomycin hydrochloride for irrigation; tobramycin sulfate for irrigation/irrigation system) in patients with periprosthetic joint infections (PJI) of the hip or knee. The two prospective, randomized, comparative studies evaluated the efficacy of a 7-day exchange arthroplasty with intra-articular antibiotic irrigation versus the current standard of care, two-stage exchange arthroplasty.
The APEX clinical program enrolled 152 patients across 23 centers in the U.S., with 76 patients treated in each study arm. Results demonstrated a statistically significant net treatment effect at 12 months of 19%. Additionally, the median time to revision arthroplasty was significantly shorter at seven days in VT-X7 patients compared to 98 days in patients with standard two-stage exchange. Of those patients completing revision arthroplasty, those treated with VT-X7 had a shorter overall procedure time by 62 minutes compared to patients treated with two-stage exchange. When considering the overall burden of PJI to the patients during the study follow-up period (i.e. time spent without a permanent implant and/or time spent as a failure), VT-X7 reduced PJI burden by 71% compared to standard two-stage exchange. Overall, the 12-month results demonstrated both a statistically significant and clinically meaningful treatment effect with VT-X7 compared to standard two-stage exchange.
VT-X7 KIT (vancomycin hydrochloride and tobramycin sulfate for irrigation/irrigation system) is a novel drug/device combination product designed to deliver therapeutic concentrations of vancomycin and tobramycin antibiotics directly to the joint space and surrounding tissue to treat PJI. VT-X7 is a 7-day therapy designed to address the unmet clinical need for a rapid, reliable treatment for these challenging infections. In clinical studies of VT-X7, 100% of patients were treated and received a new permanent joint prosthesis in seven days with >90% remaining infection-free after one year.
Source: Osteal Therapeutics, Inc.
Osteal Therapeutics announced positive 12-month results from the two APEX (Abbreviated Protocol for Two Stage Exchange) clinical trials of VT-X7 KIT (vancomycin hydrochloride for irrigation; tobramycin sulfate for irrigation/irrigation system) in patients with periprosthetic joint infections (PJI) of the hip or knee. The two prospective,...
Osteal Therapeutics announced positive 12-month results from the two APEX (Abbreviated Protocol for Two Stage Exchange) clinical trials of VT-X7 KIT (vancomycin hydrochloride for irrigation; tobramycin sulfate for irrigation/irrigation system) in patients with periprosthetic joint infections (PJI) of the hip or knee. The two prospective, randomized, comparative studies evaluated the efficacy of a 7-day exchange arthroplasty with intra-articular antibiotic irrigation versus the current standard of care, two-stage exchange arthroplasty.
The APEX clinical program enrolled 152 patients across 23 centers in the U.S., with 76 patients treated in each study arm. Results demonstrated a statistically significant net treatment effect at 12 months of 19%. Additionally, the median time to revision arthroplasty was significantly shorter at seven days in VT-X7 patients compared to 98 days in patients with standard two-stage exchange. Of those patients completing revision arthroplasty, those treated with VT-X7 had a shorter overall procedure time by 62 minutes compared to patients treated with two-stage exchange. When considering the overall burden of PJI to the patients during the study follow-up period (i.e. time spent without a permanent implant and/or time spent as a failure), VT-X7 reduced PJI burden by 71% compared to standard two-stage exchange. Overall, the 12-month results demonstrated both a statistically significant and clinically meaningful treatment effect with VT-X7 compared to standard two-stage exchange.
VT-X7 KIT (vancomycin hydrochloride and tobramycin sulfate for irrigation/irrigation system) is a novel drug/device combination product designed to deliver therapeutic concentrations of vancomycin and tobramycin antibiotics directly to the joint space and surrounding tissue to treat PJI. VT-X7 is a 7-day therapy designed to address the unmet clinical need for a rapid, reliable treatment for these challenging infections. In clinical studies of VT-X7, 100% of patients were treated and received a new permanent joint prosthesis in seven days with >90% remaining infection-free after one year.
Source: Osteal Therapeutics, Inc.
You are out of free articles for this month
Subscribe as a Guest for $0 and unlock a total of 5 articles per month.
You are out of five articles for this month
Subscribe as an Executive Member for access to unlimited articles, THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT and more.
JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
