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

Status

Indicates the current recruitment status or the expanded access status.
Temporarily not available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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