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.
CA
Harbor-UCLA Medical Center
Torrance, California
United States, 90502
Principal Investigator:
Lewis Moss, MD
Research Coordinator:
Elaine Santana
Find a location
UT
University of Utah
Salt Lake City, Utah
United States, 84108
Principal Investigator:
Jeremy Gililland, MD
Research Coordinator:
Shanna Loughmiller
MI
Covenant Medical Center
Saginaw, Michigan
United States, 48602
Principal Investigator:
Brian De Beaubien, MD bdebeaubien@gmail.com
Research Coordinator:
Melanie Akin
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania,
United States, 19107
Principal Investigator:
Max Courtney, MD Paul.Courtney@rothmanortho.com
Research Coordinator:
Alicia Reyes
PA
AZ
University of Arizona, Phoenix
Phoenix, Arizona
United States, 85004
Principal Investigator:
J. Brock Walker, MD Joseph.Walker@bannerhealth.com
Research Coordinator:
Marleny Munoz
University of Kentucky
Lexington, Kentucky
United States, 40506
Principal Investigator:
Stephen Duncan, MD
Research Coordinator:
Lindsey Ball
KY
Cleveland Clinic
Cleveland, Ohio,
United States, 44195
Principal Investigator:
Nicolas Piuzzi, MD
Research Coordinator:
PJ Rullan
OH
Ohio State University
Columbus, Ohio,
United States, 43202
Principal Investigator:
Andrew Glassman, MD
Research Coordinator:
Nikhil Punwani
TX
Texas Health Presbytarian - Plano
Plano, Texas
United States, 75093
Principal Investigator:
Kwame Ennin, MD
Research Coordinator:
Shuvalaxmi Dasgupta
OK
Integris Southwest Medical Center
Oklahoma City, Oklahoma,
United States, 73103
Principal Investigator:
Bradley Reddick
Contact:
Stephanie Plummer
NY
Columbia University
New York, New York
United States, 10032
Principal Investigator:
John Cooper, MD jcooper02@gmail.com
Research Coordinator:
Jacquelynne Lenahan
DC
UVA Orthopedics Center
Charlottesville, Virginia,
United States, 22903
Principal Investigator:
Ian Duensing, MD
NUZ2RR@hscmail.mcc.virginia.edu
Research Coordinator:
Eric McVey
emcvey@virginia.edu
VA
OrthoCarolina Research Institute, Inc
Charlotte, North Carolina
United States, 28207
Principal Investigator:
Bryan Springer, MD
Bryan.Springer@orthocarolina.com
Research Coordinator:
Taylor Rowe
NC
Cleveland Clinic - Weston
Weston, Florida
United States, 33331
Principal Investigator:
Carlos Higuera-Rueda, MD
Research Coordinator:
Jesus Villa, MD
University of Florida Health
Gainesville, Florida
United States, 32611
Principal Investigator:
Hari Parvataneni, MD
Research Coordinator:
Emilie Miley
FL