Clinical trial NCT03721328: Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
Official title: A Phase 2 Multicenter Feasibility Trial to Evaluate Safety and Efficacy in Patients Treated for Hip or Knee Prosthetic Joint Infection (PJI) With Alternating Irrigation of Vancomycin Hydrochloride (HCl) and Tobramycin Sulfate in Two-Stage Exchange Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prosthetic Joint Infection
Keywords: Hip
Knee
Biofilm
Minimum-biofilm-eradication-concentration
Lead sponsor: Osteal Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety Evaluations: Number and Frequency of Adverse Events Among Participants
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saginaw
country: United States
facility: Covenant Hospital
state: Michigan
city: Charlotte
country: United States
facility: Ortho Carolina Research Institute
state: North Carolina
city: Oklahoma City
country: United States
facility: SSM Health Bone and Joint Hospital at St. Anthony
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Ortho Carolina Research Institute
name: Bryan Springer, MD
role: PRINCIPAL_INVESTIGATOR
References: