Clinical trial NCT06383611: Expanded Access to Cyclic Irrigation in Patients Undergoing Exchange Arthroplasty
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
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Prosthetic-joint Infection
Keywords: Hip
Knee
Biofilm
Minimum biofilm eradication concentration
Lead sponsor: Osteal Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-25
Sex: ALL
Minimum age (years): 22
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner - University Medical Center Phoenix
state: Arizona
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Southwest Medical Center
state: Oklahoma
Study officials:
References: