Two-Stage Exchange Arthroplasty + VT-X7 for Prosthetic Joint Infection

(Apex-2 Trial)

No longer recruiting at 18 trial locations

Overseen By Clay Cohorn

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Osteal Therapeutics, Inc.

Must not be taking: Anticoagulants, Chemotherapy, Glucocorticoids, Biologics

Disqualifiers: Renal insufficiency, Immunodeficient, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 90

Duration: Varies based on surgical and recovery time

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment approach for infections around hip or knee replacements, known as periprosthetic joint infections (PJI). It compares the standard two-step surgery, called two-stage exchange arthroplasty, with a new system, VT-X7, which includes local antibiotic irrigation. The goal is to determine if the new method results in better outcomes, such as being infection-free and off antibiotics, at 180 days post-treatment. Individuals needing a two-part surgery for a hip or knee infection might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but it does require stopping certain biologic agents at least one dosing cycle (minimum 7 days) before surgery and for at least 14 days after surgery. If you are on long-term anticoagulation or antiplatelet therapy, you may need to adjust or stop it if recommended by your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the VT-X7 Treatment System is generally safe for patients when used with a two-step surgery to replace a joint. An initial study found that VT-X7 effectively treats infections in artificial joints, with most patients experiencing no serious side effects.

Another study on a similar quick treatment method found it was well-tolerated by patients, suggesting that the VT-X7 system might also be safe. Although the VT-X7 system remains under testing, these findings suggest it could be a safe option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for prosthetic joint infection?

Unlike the standard of care for prosthetic joint infection, which involves a two-stage exchange arthroplasty with systemic antibiotics, the VT-X7 Treatment System adds a new twist by delivering antibiotics directly to the site of infection. This localized antibiotic irrigation method is designed to enhance the effectiveness of the treatment by targeting the infection more precisely. Researchers are excited about this approach because it could potentially improve recovery times and outcomes by ensuring that the medication reaches the infected area more efficiently than traditional systemic methods.

What evidence suggests that this trial's treatments could be effective for prosthetic joint infection?

Research has shown that the VT-X7 system holds promise for treating infections in artificial joints. In this trial, participants in the experimental arm will receive local antibiotic irrigation via the VT-X7 Treatment System as an adjuvant to the standard two-stage exchange arthroplasty. After 12 months, patients using VT-X7 experienced a 19% better recovery compared to those with standard treatment, due to a significant drop in infections. Additionally, early results suggest that all patients treated with VT-X7 could receive a new joint implant within a week. These findings highlight VT-X7's potential to improve recovery and outcomes for patients with these infections. ^{1 2 3 5 6}

Who Is on the Research Team?

Nicolas Piuzzi, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am medically cleared for surgery.

Signed informed consent

I am between 22 and 84 years old.

Exclusion Criteria

I currently have an infection at my IV site.

I am currently receiving chemotherapy for cancer.

I am on drugs to suppress my immune system after a transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two-stage exchange arthroplasty with either standard care or VT-X7 system for local antibiotic irrigation

Varies based on surgical and recovery time

Follow-up

Participants are monitored for safety and effectiveness after treatment

365 days

Follow-up visits at 90, 180, and 365 days

What Are the Treatments Tested in This Trial?

Interventions

• Standard of Care
• Two-stage exchange arthroplasty
• VT-X7 Treatment System

Trial Overview 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.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 3 Interventions

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

Group II: Control Active Control 2 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.

Who Is Running the Clinical Trial?

Osteal Therapeutics, Inc.

Lead Sponsor

Trials

4

Recruited

170+

Citations

1. ostealtx.com ostealtx.com/12-month-results

Positive 12-Month Results | Osteal ... Outcomes at 12 months demonstrate a statistically significant net treatment effect of 19% compared to the standard of care two-stage exchange arthroplasty ...

2. trial.medpath.com trial.medpath.com/news/c67526bcc9280813/osteal-therapeutics-announces-positive-12-month-results-globenewswire

Osteal Therapeutics' VT-X7 KIT Demonstrates Positive Results ... Osteal Therapeutics' VT-X7 KIT shows a statistically significant 19% net treatment effect in periprosthetic joint infection (PJI) patients at 12 months compared ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12486824/

Advancing the management of prosthetic joint infections These interim results add to emerging data that challenge the current consensus favoring two-stage exchange arthroplasty for chronic PJI (24).

4. synapse.patsnap.com synapse.patsnap.com/article/osteal-therapeutics-reports-positive-six-month-apex-trial-results-at-34th-musculoskeletal-infection-society-meeting

Osteal Therapeutics Reports Positive Six-Month APEX Trial ... Clinical studies have shown that VT-X7 allowed 100% of treated patients to receive a new permanent joint prosthesis within seven days, with over ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12185653/

Outcomes following planned two-stage exchange ... Two-stage exchange arthroplasty treatment of PJIs is associated with major morbidity and often requires additional surgical procedures to address complications.

6. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(24)00313-9/fulltext

Safety Profile of Seven-Day Intra-articular Antibiotic ... This was a Phase II, multicenter, prospective randomized trial evaluating safety of a rapid (seven-day) two-stage exchange arthroplasty with IAA irrigation.