Expanded Access to Cyclic Irrigation in Patients Undergoing Exchange Arthroplasty (APEX-EAP)

April 14, 2026 updated by: Osteal Therapeutics, Inc.

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.

Study Overview

Status

Temporarily not available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients
  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner - University Medical Center Phoenix
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • St. Mary's Regional Hospital - Intermountain Health
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida Health
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Hospital Orthopedics
    • Iowa
      • North Liberty, Iowa, United States, 52317
        • University of Iowa
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri Health Care
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0212
        • University of Cincinnati
      • Columbus, Ohio, United States, 43202
        • Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Integris Southwest Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  1. 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.
  2. Patients who have failed a prior exchange arthroplasty.
  3. Signed informed consent.
  4. 22 to 84 years of age (inclusive).
  5. Medical clearance for surgery.
  6. 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.

Exclusion Criteria:

  1. 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).
  2. Patients with bacteremia or positive bacterial blood culture in the last 30 days.
  3. Patients with concurrent PJI of more than one joint.
  4. Patients with ongoing active infection of an intravenous (IV) site.
  5. 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.
  6. 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.
  7. Patients on chemotherapy for malignant disease.
  8. Patients on systemic glucocorticoid therapy (prednisone >10 mg/day or equivalent).
  9. 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.
  10. Patients who have an allergy to vancomycin hydrochloride or tobramycin sulfate (Note: prior history of red man syndrome is not considered an allergy).
  11. Patients who have an allergy to titanium, titanium alloys, polymethylmethacrylate or polyurethane.
  12. Patients who are pregnant or planning to become pregnant in the next 30 days.
  13. Patients with a fungal PJI as determined by one or more positive fluid and/or tissue cultures.
  14. Patients who have a skeletal defect greater than 150 mm in length in the tibia or femur of the infected joint.
  15. Patients who have a planned surgical procedure within 30 days of enrollment that can impact the conduct of the study.
  16. Patients who are breastfeeding.
  17. Patients who are incarcerated or are facing impending incarceration.
  18. Patients who have been in treatment for substance abuse within the past year or referred to treatment for substance abuse within the past year.
  19. 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.
  20. Patients receiving immunosuppressive drug therapy for bone marrow or another transplant.
  21. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Osteal Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 19, 2024

First Submitted That Met QC Criteria

April 19, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTX-0303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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