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

(Apex-2 Trial)

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

76 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How is the Two-Stage Exchange Arthroplasty + VT-X7 treatment different from other treatments for prosthetic joint infection?

The Two-Stage Exchange Arthroplasty + VT-X7 treatment is unique because it combines a surgical approach with a specific treatment system, VT-X7, which may offer a novel mechanism or method not typically used in standard treatments for prosthetic joint infections. This approach might involve specific criteria or timing for reimplantation, which is not well-defined in current practices. ^{1 2 3 4 5}

Research Team

Nicolas Piuzzi, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Do Pre-Reimplantation Erythrocyte Sedimentation Rate/C-Reactive Protein Cutoffs Guide Decision-Making in Prosthetic Joint Infection? Are We Flying Blind? [2022]

2. England pubmed.ncbi.nlm.nih.gov

Manual blood exchange transfusion does not significantly contribute to parasite clearance in artesunate-treated individuals with imported severe Plasmodium falciparum malaria. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Poor responder to plasma exchange therapy in acquired thrombotic thrombocytopenic purpura is associated with ADAMTS13 inhibitor boosting: visualization of an ADAMTS13 inhibitor complex and its proteolytic clearance from plasma. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Characterization of the complications associated with plasma exchange for thrombotic thrombocytopaenic purpura and related thrombotic microangiopathic anaemias: a single institution experience. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Exchange transfusion for severe malaria: evidence base and literature review. [2013]