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

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ClinicalTrials.gov Identifier: NCT03721328
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Joint Purification Systems

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 primary outcome measure is the number of successful subjects. A successful subject is defined as a subject who achieves ALL of the following qualitative criteria in a composite endpoint.

To be considered a success, patients must achieve ALL of the following components of the composite endpoint after 6 weeks of antibiotic treatment and a 2-week antibiotic holiday:

  • Have a permanent revision prosthesis implanted by 12 weeks post initial surgery; Yes or No AND
  • Have the same functioning prosthesis at 12 weeks post initial surgery; Yes or No AND
  • Show no signs of infection, per the Delphi Criteria, between implantation and 12 weeks post initial surgery Yes or No AND
  • Have no surgical intervention for infection between initial surgery and 12 weeks post initial surgery. Yes or No

Delphi Criteria: (1) infection eradication, characterized by a healed wound without fistula, drainage, or pain, and no infection recurrence caused by the same organism strain; (2) no subsequent surgical intervention after reimplantation surgery owing to infection; and (3) no occurrence of PJI-related mortality (by causes such as sepsis, necrotizing fasciitis.

Follow-up Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 1 year from initial surgery.


Condition or disease Intervention/treatment Phase
Prosthetic Joint Infection Combination Product: vancomycin hydrochloride and tobramycin sulfate Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Multicenter Feasibility Trial to Evaluate Safety and Efficacy in Patients Treated for Hip or Knee Prosthetic Joint Infection With Alternating Irrigation of Vancomycin HCl and Tobramycin Sulfate in Two-Stage Exchange Arthroplasty
Actual Study Start Date : October 26, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Experimental
Joint irrigation with vancomycin and tobramycin
Combination Product: vancomycin hydrochloride and tobramycin sulfate
vancomycin hydrochloride and tobramycin sulfate via local irrigation




Primary Outcome Measures :
  1. Number of successful subjects [ Time Frame: 12 weeks ]

    The primary outcome measure is the number of successful subjects. A successful subject is defined as a subject who achieves ALL of the following qualitative criteria encompassed in a composite endpoint.

    To be considered a success, patients must achieve ALL of the following components of the composite endpoint after 6 weeks of antibiotic treatment and a 2-week antibiotic holiday:

    • Have a permanent revision prosthesis implanted by 12 weeks post initial surgery; Yes or No AND
    • Have the same functioning prosthesis at 12 weeks post initial surgery; Yes or No AND
    • Show no signs of infection, per the Delphi Criteria, between implantation and 12 weeks post initial surgery Yes or No AND
    • Have no surgical intervention for infection between initial surgery and 12 weeks post initial surgery. Yes or No



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  • Acute PJI, defined as ≤ 28 days after the index operation
  • Late acute hematogenous infection per Tsukayama et al.
  • Patients for whom a two-stage exchange arthroplasty is not indicated
  • Systemic 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 (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721328


Contacts
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Contact: Kimberly Martin, PhD 303.261.7891 kim.martin@boulderclinicalscience.com
Contact: Jude Paganelli, MSE 858-774-7891 Jude@cormedicalventures.com

Locations
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United States, Colorado
Sky Ridge Hospital Not yet recruiting
Lone Tree, Colorado, United States, 80124
Contact: Kim Martin, Phd    303-261-7891    kim.martin@boulderclinicalscience.com   
United States, Indiana
Ortho Indy Not yet recruiting
Indianapolis, Indiana, United States, 46278
Contact: Molly Miller    317-802-2851    molmiller@orthoindy.com   
Principal Investigator: Edward Helman, MD         
United States, Michigan
Covenant Hospital Recruiting
Saginaw, Michigan, United States, 48604
Contact: Dianne Androsuk    989-583-5173    dianne.androsuk@chs-mi.com   
Principal Investigator: Brian de Beaubian, MD         
United States, North Carolina
Ortho Carolina Research Institute Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Amy Roznowski    704-323-2263    amy.roznowski@orthocarolina.com   
Contact: Christi Cadd    704-323-2263    Christi.Cadd@orthocarolina.com   
Principal Investigator: Bryan Springer, MD         
United States, Pennsylvania
University of Pittsburgh Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Tina Vita, BSN    412-864-3654    vitatm@upmc.edu   
Principal Investigator: Kenneth Urish, MD         
Sponsors and Collaborators
Joint Purification Systems
Investigators
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Principal Investigator: Bryan Springer, MD Ortho Carolina Research Institute

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Responsible Party: Joint Purification Systems
ClinicalTrials.gov Identifier: NCT03721328     History of Changes
Other Study ID Numbers: JPS-001
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Joint Purification Systems:
Hip
Knee
Biofilm
Minimum-biofilm-eradication-concentration

Additional relevant MeSH terms:
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Infection
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases
Vancomycin
Tobramycin
Anti-Bacterial Agents
Anti-Infective Agents