TEMPORARILY_NOT_AVAILABLENot Applicable

Expanded Access to Cyclic Irrigation in Patients Undergoing Exchange Arthroplasty

United States

Plain-language 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.

Who can participate

Age range22 Years – 84 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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).

Trial details

NCT IDNCT06383611

SponsorOsteal Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

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