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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06383611
- Acronym / sponsor ID
- APEX-EAP / OTX-0303
- Conditions
- Prosthetic-joint Infection
- Keywords
- Hip, Knee, Biofilm, Minimum biofilm eradication concentration
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- Osteal Therapeutics, Inc.Industry (pharma, biotech, devices)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- 22 to 84 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VT-X7 Treatment SystemLocal antibiotic irrigation via the VT-X7 Treatment System adjuvant to two-stage exchange arthroplasty per standard of care. | Combination product | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VT-X7 Treatment System in people with Prosthetic-joint Infection, run by Osteal Therapeutics, Inc. at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.