Prosthetic-joint InfectionAPEX-EAPNCT06383611
Expanded Access to Cyclic Irrigation in Patients Undergoing Exchange Arthroplasty
A study testing VT-X7 Treatment System in people with Prosthetic-joint Infection, run by Osteal Therapeutics, Inc. at 14 sites in United States.
Trial summary
The objective of the protocol is to provide access to the VT-X7 (Vancomycin, Tobramycin Exchanged in 7 Days) system for subjects with periprosthetic joint infection (PJI) of the hip or knee who lack therapeutic treatment alternatives. Read more about this study
- Who is it for?
- Ages 22 to 84 years
- Conditions the study is for
- Prosthetic-joint Infection
- What is being tested?
- VT-X7 Treatment System
- How many people
- Not given
- Where
- 14 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 84 years
- All sexes
- Adult, Older adult
Who may be able to join
- Planned removal of hip or knee prosthesis as part of an exchange arthroplasty, due to hip or knee PJI. The prosthesis removed may be either i) a permanent implant or, ii) a temporary spacer implanted during a resection arthroplasty.
- Patients who have failed a prior exchange arthroplasty.
- Signed informed consent.
- 22 to 84 years of age (inclusive).
- Medical clearance for surgery.
- Pre-enrollment diagnosis of PJI of the hip or knee per the International Consensus Meeting of Musculoskeletal Infection (ICMMI) 2018 definition of Periprosthetic Hip and Knee Infection.
Who cannot join
- Patients who are judged by the Study Site PI to be unsuitable for the study (i.e., current medical condition that would interfere with study conduct or results or unreliable for required study follow-up).
- Patients with bacteremia or positive bacterial blood culture in the last 30 days.
- Patients with concurrent PJI of more than one joint.
- Patients with ongoing active infection of an intravenous (IV) site.
- Patients who require long-term anticoagulation or antiplatelet therapy, and for whom bridging or withholding therapy is not recommended based on the individual's clinical condition.
- Patients with advanced renal insufficiency (i.e., chronic kidney disease (CKD) Stage 4 or 5 or patients with an estimated glomerular filtration rate (eGFR) <30 mL/min) measured within 180 days of consent.
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- Patients on chemotherapy for malignant disease.
- Patients on systemic glucocorticoid therapy (prednisone >10 mg/day or equivalent).
- Patients who are immunodeficient (e.g., splenectomy, sickle cell anemia, Stage 3 human immunodeficiency virus (HIV) infection, primary immunodeficiency disease), except patients who are immunodeficient due to immunosuppressive therapy.
- Patients who have an allergy to vancomycin hydrochloride or tobramycin sulfate (Note: prior history of red man syndrome is not considered an allergy).
- Patients who have an allergy to titanium, titanium alloys, polymethylmethacrylate or polyurethane.
- Patients who are pregnant or planning to become pregnant in the next 30 days.
- Patients with a fungal PJI as determined by one or more positive fluid and/or tissue cultures.
- Patients who have a skeletal defect greater than 150 mm in length in the tibia or femur of the infected joint.
- Patients who have a planned surgical procedure within 30 days of enrollment that can impact the conduct of the study.
- Patients who are breastfeeding.
- Patients who are incarcerated or are facing impending incarceration.
- Patients who have been in treatment for substance abuse within the past year or referred to treatment for substance abuse within the past year.
- Patients who will participate in another clinical study of an investigational drug or investigational device or have participated in another clinical study of an investigational drug or investigational device within the past 30 days that would interfere with the study results or the conduct of the study.
- Patients receiving immunosuppressive drug therapy for bone marrow or another transplant.
- Patients who receive therapy including any of the following biologic agents, which will not be withheld for a period beginning at least one dosing cycle (minimum 7 days) prior to planned surgery and ending at least 14 days following planned surgery:
- Adalimumab (Humira) Tocilizumab (Actemra) Etanercept (Enbrel) Anakinra (Kineret) Golimumab (Simponi) Secukinumab (Cosentyx) Infliximab (Remicade) Ustekinumab (Stelara) Abatacept (Orencia) Tofacitinib (Xeljanz) Belimumab (Benlysta)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Cincinnati
Cincinnati, Ohio, 45267-0212
University of Missouri Health Care
Columbia, Missouri, 65212
Ohio State University
Columbus, Ohio, 43202
Parkview Hospital Orthopedics
Fort Wayne, Indiana, 46845
University of Florida Health
Gainesville, Florida, 32608
St. Mary's Regional Hospital - Intermountain Health
Grand Junction, Colorado, 81501
Houston Methodist Medical Center
Houston, Texas, 77030
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of Iowa
North Liberty, Iowa, 52317
Integris Southwest Medical Center
Oklahoma City, Oklahoma, 73109
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006
Mayo Clinic Rochester
Rochester, Minnesota, 55905
About this study
Official title: Protocol for Expanded Access to Cyclic Irrigation of Vancomycin Hydrochloride and Tobramycin Sulfate in Patients Undergoing Exchange Arthroplasty for Periprosthetic Joint Infection of the Hip or Knee
The objective of the protocol is to provide access to the VT-X7 (Vancomycin, Tobramycin Exchanged in 7 Days) system for subjects with periprosthetic joint infection (PJI) of the hip or knee who lack therapeutic treatment alternatives.
- Conditions
- Prosthetic-joint Infection
- Being tested
- VT-X7 Treatment System
- Keywords
- Hip, Knee, Biofilm, Minimum biofilm eradication concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VT-X7 Treatment SystemCombination product
Local antibiotic irrigation via the VT-X7 Treatment System adjuvant to two-stage exchange arthroplasty per standard of care.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic-joint InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Osteal Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383611
- Sponsor's protocol ID
- OTX-0303
- Acronym
- APEX-EAP
- Status last verified
- Oct 2026
- First submitted
- 19 Apr 2024
- Last updated
- 15 Oct 2026
- Results posted
- No