Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation

O

Osteal Therapeutics

Status and phase

Completed
Phase 2

Conditions

Prosthetic Joint Infection

Treatments

Combination Product: vancomycin hydrochloride and tobramycin sulfate

Study type

Interventional

Funder types

Industry

Identifiers

NCT03721328
JPS-001

Details and patient eligibility

About

Study Type Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial. Primary Study Objective The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI. Primary Outcome Measure The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions. Follow-up Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from initial surgery.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥18 years or greater
  • Preoperative diagnosis of PJI of the hip or knee per the 2018 Definition of Periprosthetic Hip and Knee Infection
  • Chronic PJI (symptoms lasting at least 4 weeks) per Tsukayama et al.
  • Medical clearance for surgery
  • Physical and mental ability and willingness to comply with the protocol, including the ability to read and complete required forms, and willingness and ability to adhere to the scheduled follow-up visits and requirements of the protocol

Exclusion criteria

  • Late acute hematogenous infection per Tsukayama et al.
  • Patients for whom a two-stage exchange arthroplasty is not indicated
  • Sepsis
  • Previously failed single- or two-stage revision arthroplasty for PJI (aseptic revision, polyethylene liner exchange, and/or irrigation and debridement with component retention is allowed)
  • Patients with PJI of more than one joint
  • Patients on chronic antibiotic therapy (≥ 6 months duration)
  • Patients who require therapeutic anticoagulation
  • Patients on antiplatelet therapy for whom withholding antiplatelet therapy for any amount of time is contraindicated
  • Patients with renal insufficiency/failure (serum creatinine ≥ 2.0 mg/dl)
  • Patients with uncontrolled diabetes, defined as: hemoglobin A1C levels > 8.0%
  • Patients on immunosuppressive therapy, chemotherapy for malignant disease, or glucocorticoid therapy (e.g. prednisone ≥ 10 mg/day).
  • Patients with immunodeficiency (e.g., splenectomy; sickle cell anemia; Stage 3 HIV; primary humoral, bone marrow, or other transplantation.)
  • Anticipated or potential patient relocation that may interfere with follow-up examinations
  • Allergy to vancomycin HCl or tobramycin sulfate (Note: prior history of Red Man's syndrome is not considered an allergy)
  • Patients who are pregnant or planning to become pregnant
  • Patients in whom negative pressure wound therapy is contraindicated
  • Patients infected with pathogens that are not considered susceptible to vancomycin HCl or tobramycin sulfate, as per the Investigator's opinion
  • Breastfeeding at screening visit
  • Patients who are prisoners
  • Participation in another clinical trial of another Investigational Drug or Investigational Device within the past 30 days

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

15 participants in 1 patient group

Experimental
Experimental group
Description:
Joint irrigation with vancomycin and tobramycin
Treatment:
Combination Product: vancomycin hydrochloride and tobramycin sulfate

Trial documents
1

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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