Expanded Access to Cyclic Irrigation in Patients Undergoing Exchange Arthroplasty

NCT06383611 | Unknown

• 1 other identifier: OTX-0303
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 14

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.

Conditions

Prosthetic-joint Infection

Keywords

Hip; Knee; Biofilm; Minimum biofilm eradication concentration

Interventions

VT-X7 Treatment System COMBINATION_PRODUCT

Local antibiotic irrigation via the VT-X7 Treatment System adjuvant to two-stage exchange arthroplasty per standard of care.

Eligibility Criteria

• Age: 22 Years - 84 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Osteal Therapeutics, Inc.: lead

Study Sites (14)

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

St. Mary's Regional Hospital - Intermountain Health

Grand Junction, Colorado, 81501, United States

Location

University of Florida Health

Gainesville, Florida, 32608, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Parkview Hospital Orthopedics

Fort Wayne, Indiana, 46845, United States

Location

University of Iowa

North Liberty, Iowa, 52317, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

University of Missouri Health Care

Columbia, Missouri, 65212, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-0212, United States

Location

Ohio State University

Columbus, Ohio, 43202, United States

Location

Integris Southwest Medical Center

Oklahoma City, Oklahoma, 73109, United States

Location

Houston Methodist Medical Center

Houston, Texas, 77030, United States

Location

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 25, 2024
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (14)