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.
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
Stage 1: Remove Infected Implant
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Surgery to remove the infected implant
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Insert temporary spacer containing antibiotic powder
Standard Treatment
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Intravenous antibiotics for at least 6 weeks
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Surgeon watches for ongoing infection
Stage 2: New Permanent Implant
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Surgery to remove the spacer and implant a permanent joint replacement
Rapid Two-Stage Surgery
Stage 1: Remove Infected Implant
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Surgery to remove the infected implant
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Insert a VT-X7 titanium spacer
VT-X7 Treatment
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Antibiotics irrigated through the infected joint space for 7 days
Stage 2: New Permanent Implant
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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.
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
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Antibiotic concentrations at the infection site sufficient to penetrate biofilm
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Effective against gram-negative and gram-positive organisms
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Low antibiotic serum concentrations
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Infection is treated and patient receives new revision prothesis in 7 days
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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:
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I have been diagnosed with periprosthetic joint infection (PJI).
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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
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
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
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
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
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
Principal Investigator:
Carlos Higuera-Rueda, MD
FL