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For patients diagnosed with Periprosthetic Joint Infection

The APEX Clinical Study

The APEX clinical study is studying a rapid 7-day treatment for PJI of the hip or knee using VT-X7. Patients who qualify and decide to enroll in the study will be randomly assigned to treatment with either VT-X7 or standard two-stage exchange surgery. Patients have equal chances of receiving VT-X7 or standard treatment but will not be told which treatment they received until they awake from the first surgery. 

What is PJI?

Periprosthetic joint infection (PJI) is a rare but serious complication after joint replacement surgery. PJI occurs when bacteria grow around your artificial joint, causing pain and swelling. Typically, these infections occur within five years of joint replacement surgery but can happen at any time. If left untreated, PJI can lead to amputation of the infected limb or even death. 
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What is Standard Treatment for PJI?

Your doctor may have recommended two-stage exchange arthroplasty (surgery) to treat your PJI. This involves removing the infected artificial hip or knee (stage 1), treating the infected tissue and bone with antibiotics, and implanting a new artificial joint (stage 2). Eliminating the infection requires intravenous (IV) antibiotics and placement of a temporary spacer that slowly releases antibiotics. After confirming the infection is gone, the surgeon will implant a new artificial joint. The total treatment time is typically about 16 weeks.

Standard Two-Stage Surgery

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Stage 1: Remove Infected Implant

  • Surgery to remove the infected implant
  • Insert temporary spacer containing antibiotic powder

Standard Treatment  

  • Intravenous antibiotics for at least 6 weeks
  • Surgeon watches for ongoing infection

Stage 2: New Permanent Implant

  • Surgery to remove the spacer and implant a permanent joint replacement

Rapid Two-Stage Surgery

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Stage 1: Remove Infected Implant

  • Surgery to remove the infected implant
  • Insert a VT-X7 titanium spacer

VT-X7 Treatment 

  • Antibiotics irrigated through the infected joint space for 7 days

Stage 2: New Permanent Implant

  • Surgery to remove VT-X7 spacer and implant a permanent joint replacement
 

What is VT-X7?

VT-X7 is a drug-device combination that delivers high concentrations of vancomycin and tobramycin, well-established antibiotic drugs, directly to the infected joint space.  When used as part of a two-stage exchange arthroplasty procedure, VT-X7 has the potential to significantly lower treatment time and improve success rates.
VT-X7 is an investigational product. Limited by federal law to investigational use.
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How does it work?

VT-X7 works by directly delivering antibiotics to the site of infection which means the bacteria infecting the joint are exposed to higher sustained concentrations.

Flushes the Joint Space
with Antibiotics

150+ Times
in 7 Days

Expected Advantages of VT-X7

  • Antibiotic concentrations at the infection site sufficient to penetrate biofilm
  • Effective against gram-negative and gram-positive organisms
  • Low antibiotic serum concentrations
  • Infection is treated and patient receives new revision prothesis in 7 days
  • Durable results: >90% of patients are infection free at 1 year post treatment

Is APEX right for you?

Talk to your doctor about enrolling in the APEX clinical study if you say YES to the following statements:​
  • I have been diagnosed with periprosthetic joint infection (PJI).
  • I have been told I need two stage exchange surgery. 

Can I choose VT-X7?

VT-X7 is an investigational product limited by US law to investigational use only. It is not available for sale and cannot be offered outside of the APEX study. 

Successful Phase 2 Results

Osteal Therapeutics conducted a Phase 2 prospective, single-arm, clinical trial for the treatment of patients with infected hip and knee prostheses at 4 U.S. centers. In the trial all subjects received new revision joint prostheses after 7 days of therapy and a clinically and statistically significant percentage of subjects were infection free at 12 weeks and 1 year.

 

Find a location

UT

University of Utah

Salt Lake City, Utah,
United States, 84108

Contact: Jeremy Gililland, MD  Jeremy.Gililland@hsc.utah.edu

Contact: Shanna Loughmiller   Shanna.Loughmiller@hsc.utah.edu 

Principal Investigator:

Jeremy Gililland, MD

MI

Covenant Medical Center

Saginaw, Michigan,
United States, 48602

Contact: Brian De Beaubien  bdebeaubien@gmail.com   

Contact: Melanie Akin   

MAkin@chs-mi.com 

Principal Investigator:

Brian De Beaubien, MD

KY

University of Kentucky

Lexington, Kentucky,
United States, 40506

Contact: Stephen Duncan  stdunc2@uky.edu   

Contact: Cale Jacobs    cale.jacobs@uky.edu 

Principal Investigator:

Stephen Duncan, MD

NY

Columbia

New York, New York,
United States, 10032

Contact: John Cooper  jcooper02@gmail.com

Contact: Jacquelynne Lenahan   jl5092@cumc.columbia.edu

Principal Investigator:

John Cooper, MD

New York University

New York, New York,
United States, 10003

Contact: Ran Schwarzkopf  Ran.Schwarzkopf@nyulangone.org 

Contact: Daniel Waren    Daniel.Waren@nyulangone.org

Principal Investigator:

Ran Schwarzkopf, MD

OH

Ohio State University

Columbus, Ohio,
United States, 43202

Contact: Andrew Glassman    Andrew.Glassman@osumc.edu 

Contact: Elizabeth Sheridan      elizabeth.sheridan@osumc.edu

Principal Investigator:

Andrew Glassman, MD

Cleveland Clinic

Cleveland, Ohio,
United States, 44195

Contact: Nicolas Piuzzi piuzzin@ccf.org

Contact: Alison Klika

KLIKAA@ccf.org

Principal Investigator:

Nicolas Piuzzi, MD

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania,
United States, 19107

Contact: Paul M Courtney  Paul.Courtney@rothmanortho.com

Contact: Thema Nicholson 

thema.nicholson@rothmanortho.com

Principal Investigator:

Paul Courtney, MD

PA

VA

UVA Orthopedics Center

Charlottesville, Virginia,
United States, 22903

Contact: Ian Duensing, MD   

NUZ2RR@hscmail.mcc.virginia.edu

 

Contact: Eric McVey   
emcvey@virginia.edu

Principal Investigator:  Ian Duensing, MD 

DC

VA Medical Center

Washington, District of Columbia, United States, 20422

Contact: Katharine Harper  Katharine.Harper@va.gov

Contact: Priscilla Adler      Priscilla.Adler@va.gov    

Principal Investigator:

Katharine Harper, MD

NC

OrthoCarolina Research Institute, Inc

Charlotte, North Carolina,
United States, 28207

Contact: Bryan Springer  

Bryan.Springer@orthocarolina.com

Contact: Taylor Rowe    

Taylor.Rowe@orthocarolina.com

Principal Investigator:

Bryan Springer, MD

CA

Harbor-UCLA Medical Center

Torrance, California,
United States, 90502

Contact: Lewis Moss, MD lmoss@dhs.lacounty.gov

Contact: Elaine Santana

esantana@lundquist.org

Principal Investigator: Lewis Moss, MD

OK

Integris Southwest Medical Center

Oklahoma City, Oklahoma,
United States, 73103

Contact: Bradley Reddick   osu2doc@hotmail.com  

Contact: Stephanie Plummer

splummer122803@gmail.com

Principal Investigator:

Bradley Reddick, DO

University of Florida

Gainesville, Florida,
United States, 32611 

Contact: Hari Parvataneni      parvahk@ortho.ufl.edu   

Contact: Emilie Miley      mileyen@ortho.ufl.edu  

 

Principal Investigator:

Hari Parvataneni, MD

Cleveland Clinic

Weston, Florida,
United States, 33331

Contact: Carlos Higuera-Rueda  HIGUERC@ccf.org 

Contact: Jesus Villa    

VillaJ2@ccf.org 

Principal Investigator:

Carlos Higuera-Rueda, MD

FL

 

Sponsors and Collaborators

Osteal Therapeutics®
Osteal Therapeutics® is a privately-held, clinical-stage pharmaceutical company developing novel musculoskeletal therapeutics to treat orthopedic infections and their consequences.
Osteal Therapeutics employs a low risk development strategy by improving delivery of pharmaceuticals with long histories of safety and efficacy.
The company is lead by a highly experienced team of orthopedic industry veterans supported by world-class clinical partners.
www.ostealtx.com
Learn More
For more information about ongoing clinical study of VT-X7, visit https://clinicaltrials.gov/ct2/show/NCT04662632.
Protocol JPS-0301