What side effects are associated with this type of intervention?

Common treatments for Prosthetic Joint Infection (PJI) include antibiotics and surgical interventions like two-stage exchange procedures. Antibiotic therapy can cause gastrointestinal disturbances, allergic reactions, and potential nephrotoxicity or hepatotoxicity. Surgical interventions carry risks such as surgical site infections, blood loss, and anesthesia-related complications. Prolonged antibiotic use may also lead to antibiotic resistance and secondary infections.

What prior FDA approvals exist?

The FDA has approved several treatments for Prosthetic Joint Infection (PJI), primarily focusing on antibiotics and surgical interventions. Commonly used antibiotics include vancomycin and daptomycin, which are effective against methicillin-resistant Staphylococcus aureus (MRSA). Surgical treatments often involve a two-stage exchange procedure, where the infected prosthesis is removed, the infection is treated with antibiotics, and a new prosthesis is implanted. The VT-X7 system, currently under trial, aims to enhance these outcomes by improving the success rate of prosthesis implantation and reducing complications such as infections and the need for further surgeries.

What other types of research exist?

Promising alternatives to the VT-X7 system for PJI patients include: 1) Tranexamic Acid (TXA) administration, which has shown effectiveness in reducing blood loss and potentially lowering infection rates in joint arthroplasty. 2) Direct Oral Anticoagulants (DOACs) like apixaban, rivaroxaban, and dabigatran, which are being explored for their efficacy in thromboprophylaxis and potential benefits in reducing post-surgical complications. 3) Advanced mechanical prophylaxis methods such as pneumatic compression devices and foot pumps, which aid in early mobilization and reduce the risk of thromboembolic events. 4) Minimally invasive surgical techniques and enhanced recovery protocols that focus on reducing surgical trauma and improving post-operative outcomes.

← Back to Search

Procedure

Two-Stage Exchange Arthroplasty + VT-X7 for Prosthetic Joint Infection (Apex-2 Trial)

Phase 2

Waitlist Available

Led By Nicolas Piuzzi, MD

Research Sponsored by Osteal Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 365 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the VT-X7 system, a new treatment for patients needing a replacement for a failed joint implant. It aims to prevent infections, reduce the need for further surgeries and antibiotics, and lower the risk of death. Patients will be checked periodically to see how well it works.

Who is the study for?

This trial is for adults aged 22-84 with hip or knee infections needing a two-stage exchange arthroplasty. They must understand and agree to the study, be medically cleared for surgery, and meet specific infection criteria. Excluded are those on high-dose steroids, immunodeficient (except from therapy), allergic to certain materials in the device, recently in other drug/device trials, treated for substance abuse within a year, have psychiatric disorders affecting study participation, multiple joint infections or severe kidney issues.

What is being tested?

The Apex-2 trial tests if the VT-X7 system is better than standard care at treating joint infections after prosthesis implantation. Success includes no infection signs at day 180 post-surgery without antibiotics or additional surgeries and survival of patients. Quality of life will also be assessed up to one year.

What are the potential side effects?

Potential side effects aren't detailed but may include typical surgical risks like infection risk increase due to the device's materials or reactions related to any new technology used during treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 365 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~365 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Adverse Event Rate

Overall Treatment Success

Quality Adjusted Life Years

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExperimentalExperimental Treatment2 Interventions

Local antibiotic irrigation via the VT-X7 Treatment System adjuvant to two-stage exchange arthroplasty per SOC.

Group II: ControlActive Control2 Interventions

SOC for treatment of chronic PJI - two-stage exchange arthroplasty: surgical removal of the infected implant, aggressive debridement, and exchange arthroplasty with administration of adjuvant systemic antibiotics and temporary antibiotic-impregnated cement spacer.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Two-stage exchange arthroplasty

2021

Completed Phase 2

~80

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Prosthetic Joint Infection (PJI) include antibiotic therapy, surgical intervention, and advanced systems like the VT-X7. Antibiotic therapy targets and eradicates the infection-causing bacteria, often requiring prolonged and combination regimens. Surgical interventions, such as debridement and one- or two-stage exchange arthroplasty, remove infected tissue and hardware, replacing them with sterile components. The VT-X7 system likely uses advanced materials or coatings to reduce bacterial adhesion and biofilm formation, improving prosthesis outcomes and reducing complications like infections and further surgeries. These treatments are vital for PJI patients as they enhance prosthesis success, patient mobility, and overall quality of life.