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Intraosseous Antibiotics for Osseointegration (IOAOI)

9. Juni 2026 aktualisiert von: Wake Forest University Health Sciences
The purpose of this research study is to learn about the characteristics of infection in osseointegration patients. This research study will also study how safe and effective it is to use antibiotics inside the bone.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The goal of this multi-center prospective trial is to assess the characteristics of infection among patients with osseointegrated prosthesis and the safety and effectiveness of intraosseous antibiotic delivery.

Participants will enroll in an observational arm. Participants who require surgery for infection may enroll in an interventional arm assessing the safety and feasibility of intraosseous antibiotic administration as a potential treatment for infection.

Studientyp

Interventionell

Einschreibung (Geschätzt)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Colorado
      • Aurora, Colorado, Vereinigte Staaten, 80045
        • University of Colorado Anschutz Medical Campus
        • Kontakt:
        • Hauptermittler:
          • Danielle Melton, MD
    • New York
      • New York, New York, Vereinigte Staaten, 10021
        • Hospital for Special Surgery
        • Kontakt:
        • Hauptermittler:
          • S. Robert Rozbruch, MD
    • North Carolina
      • Charlotte, North Carolina, Vereinigte Staaten, 28203
        • Atrium Health Carolinas Medical Center
        • Hauptermittler:
          • Joseph R Hsu, MD
        • Kontakt:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • University of Pennsylvania Perelman School of Medicine
        • Hauptermittler:
          • Benjamin Potter, MD
        • Kontakt:
    • Texas
      • San Antonio, Texas, Vereinigte Staaten, 78229
        • UT Health San Antonio
        • Kontakt:
        • Hauptermittler:
          • Joseph Alderete, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • Treated with osseointegration for transfemoral, transhumeral, or transtibial amputation and presenting with concern for surgical site infection
  • >18 years of age

Exclusion Criteria:

  • Unable to follow up at site for 1 year
  • Patients that speak neither English nor Spanish
  • <18 years of age

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Observational
Patients that do not require surgery for infection
Experimental: Intraosseous Antibiotics for Osseointegration
Patients that require surgery for infection
Verfahren: intraosseous antibiotic delivery
After debridement, patients will receive intraosseous (IO) vancomycin 500mg in 150ml of normal saline during surgery. The solution will be prepared by the hospital pharmacy and administered via an IO cannula. The cannula will be placed proximal to the intramedullary fixture. In cases where a tourniquet can be utilized proximal to the IO cannula, the antibiotic is delivered as a bolus. Tourniquet must be up for 1 hour after installation of the IO cases where the residual limb is too short to allow tourniquet (pneumatic or elastic) proximal to the IO cannula, the intraosseous antibiotic must be infused at a rate not to exceed 10mg/min or less. This can be accomplished by connecting intravenous tubing to the antibiotic mixture and the IO cannula. In cases without a tourniquet, IO infusion should begin during the irrigation phase and continue through the complete closure of the wound, since it requires a significant amount of time 50-60 min.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Patients Who Develop Wound Dehiscence
Zeitfenster: Week 2
Wound Dehiscence is a complication that is assessed by the surgeon and clinical team and is documented in the patient's chart. It is Yes/No.
Week 2
Number of Patients Who Develop Wound Dehiscence
Zeitfenster: Week 6
Wound Dehiscence is a complication that is assessed by the surgeon and clinical team and is documented in the patient's chart. It is Yes/No.
Week 6
Number of Patients Who Develop Wound Dehiscence
Zeitfenster: Month 3
Wound Dehiscence is a complication that is assessed by the surgeon and clinical team and is documented in the patient's chart. It is Yes/No.
Month 3
Number of Patients Who Develop Wound Dehiscence
Zeitfenster: Month 6
Wound Dehiscence is a complication that is assessed by the surgeon and clinical team and is documented in the patient's chart. It is Yes/No.
Month 6
Number of Patients Who Develop Wound Dehiscence
Zeitfenster: Month 12
Wound Dehiscence is a complication that is assessed by the surgeon and clinical team and is documented in the patient's chart. It is Yes/No.
Month 12
Number of Patients Who Develop Superficial Infection
Zeitfenster: Week 2
Superficial Infection is a complication that is assessed by the surgeon and clinical team and is documented in the patient's chart. It is yes/no.
Week 2
Number of Patients Who Develop Superficial Infection
Zeitfenster: Week 6
Superficial Infection is a complication that is assessed by the surgeon and clinical team and is documented in the patient's chart. It is yes/no.
Week 6
Number of Patients Who Develop Superficial Infection
Zeitfenster: Month 3
Superficial Infection is a complication that is assessed by the surgeon and clinical team and is documented in the patient's chart. It is yes/no.
Month 3
Number of Patients Who Develop Superficial Infection
Zeitfenster: Month 6
Superficial Infection is a complication that is assessed by the surgeon and clinical team and is documented in the patient's chart. It is yes/no.
Month 6
Number of Patients Who Develop Superficial Infection
Zeitfenster: Month 12
Superficial Infection is a complication that is assessed by the surgeon and clinical team and is documented in the patient's chart. It is yes/no.
Month 12
Number of Patients Who Develop Deep Surgical Site Infection
Zeitfenster: Week 2
Number of participants in each group who develop surgical site infection as defined by the criteria establish by the Centers for Disease Control and Prevention (CDC). The CDC criteria define deep as occurring within 30 or 90 days after the procedure. However, we will continue to follow patients for 12 months and document any infections and other complications during this period.
Week 2
Number of Patients Who Develop Deep Surgical Site Infection
Zeitfenster: Week 6
Number of participants in each group who develop surgical site infection as defined by the criteria establish by the Centers for Disease Control and Prevention (CDC). The CDC criteria define deep as occurring within 30 or 90 days after the procedure. However, we will continue to follow patients for 12 months and document any infections and other complications during this period.
Week 6
Number of Patients Who Develop Deep Surgical Site Infection
Zeitfenster: Month 3
Number of participants in each group who develop surgical site infection as defined by the criteria establish by the Centers for Disease Control and Prevention (CDC). The CDC criteria define deep as occurring within 30 or 90 days after the procedure. However, we will continue to follow patients for 12 months and document any infections and other complications during this period.
Month 3
Number of Patients Who Develop Deep Surgical Site Infection
Zeitfenster: Month 6
Number of participants in each group who develop surgical site infection as defined by the criteria establish by the Centers for Disease Control and Prevention (CDC). The CDC criteria define deep as occurring within 30 or 90 days after the procedure. However, we will continue to follow patients for 12 months and document any infections and other complications during this period.
Month 6
Number of Patients Who Develop Deep Surgical Site Infection
Zeitfenster: Month 12
Number of participants in each group who develop surgical site infection as defined by the criteria establish by the Centers for Disease Control and Prevention (CDC). The CDC criteria define deep as occurring within 30 or 90 days after the procedure. However, we will continue to follow patients for 12 months and document any infections and other complications during this period.
Month 12
Number of Patients With Treatment Failure
Zeitfenster: Week 2
Treatment failure is defined as explant of the OI implant for any reason. Treatment failure will also be defined as additional surgical complications, wound complications, need for chronic antibiotic suppression, readmission, and reoperation.
Week 2
Number of Patients With Treatment Failure
Zeitfenster: Week 6
Treatment failure is defined as explant of the OI implant for any reason. Treatment failure will also be defined as additional surgical complications, wound complications, need for chronic antibiotic suppression, readmission, and reoperation.
Week 6
Number of Patients With Treatment Failure
Zeitfenster: Month 3
Treatment failure is defined as explant of the OI implant for any reason. Treatment failure will also be defined as additional surgical complications, wound complications, need for chronic antibiotic suppression, readmission, and reoperation.
Month 3
Number of Patients With Treatment Failure
Zeitfenster: Month 6
Treatment failure is defined as explant of the OI implant for any reason. Treatment failure will also be defined as additional surgical complications, wound complications, need for chronic antibiotic suppression, readmission, and reoperation.
Month 6
Number of Patients With Treatment Failure
Zeitfenster: Month 12
Treatment failure is defined as explant of the OI implant for any reason. Treatment failure will also be defined as additional surgical complications, wound complications, need for chronic antibiotic suppression, readmission, and reoperation.
Month 12
Rate of Adverse Events
Zeitfenster: Week 2
The proportion of participants experiencing ≥1 adverse event during the study period will be assessed to evaluate safety. Adverse events include any unfavorable or unintended medical occurrence, regardless of relatedness, including surgical, infectious, wound-related, or systemic events. Events will be collected prospectively and categorized by severity and relatedness.
Week 2
Rate of Adverse Events
Zeitfenster: Week 6
The proportion of participants experiencing ≥1 adverse event during the study period will be assessed to evaluate safety. Adverse events include any unfavorable or unintended medical occurrence, regardless of relatedness, including surgical, infectious, wound-related, or systemic events. Events will be collected prospectively and categorized by severity and relatedness.
Week 6
Rate of Adverse Events
Zeitfenster: Month 3
The proportion of participants experiencing ≥1 adverse event during the study period will be assessed to evaluate safety. Adverse events include any unfavorable or unintended medical occurrence, regardless of relatedness, including surgical, infectious, wound-related, or systemic events. Events will be collected prospectively and categorized by severity and relatedness.
Month 3
Rate of Adverse Events
Zeitfenster: Month 6
The proportion of participants experiencing ≥1 adverse event during the study period will be assessed to evaluate safety. Adverse events include any unfavorable or unintended medical occurrence, regardless of relatedness, including surgical, infectious, wound-related, or systemic events. Events will be collected prospectively and categorized by severity and relatedness.
Month 6
Rate of Adverse Events
Zeitfenster: Month 12
The proportion of participants experiencing ≥1 adverse event during the study period will be assessed to evaluate safety. Adverse events include any unfavorable or unintended medical occurrence, regardless of relatedness, including surgical, infectious, wound-related, or systemic events. Events will be collected prospectively and categorized by severity and relatedness.
Month 12
Rate of antibiotic-complications
Zeitfenster: Week 2
The proportion of participants experiencing ≥1 antibiotic-related complication during treatment will be assessed. Complications include clinically significant events attributable to antibiotic exposure (e.g., allergic reactions, gastrointestinal intolerance, hepatotoxicity, nephrotoxicity, hematologic abnormalities, or local administration-related reactions). Events will be identified through clinical assessment, laboratory data, and medical record review.
Week 2
Rate of antibiotic-complications
Zeitfenster: Week 6
The proportion of participants experiencing ≥1 antibiotic-related complication during treatment will be assessed. Complications include clinically significant events attributable to antibiotic exposure (e.g., allergic reactions, gastrointestinal intolerance, hepatotoxicity, nephrotoxicity, hematologic abnormalities, or local administration-related reactions). Events will be identified through clinical assessment, laboratory data, and medical record review.
Week 6
Rate of antibiotic-complications
Zeitfenster: Month 3
The proportion of participants experiencing ≥1 antibiotic-related complication during treatment will be assessed. Complications include clinically significant events attributable to antibiotic exposure (e.g., allergic reactions, gastrointestinal intolerance, hepatotoxicity, nephrotoxicity, hematologic abnormalities, or local administration-related reactions). Events will be identified through clinical assessment, laboratory data, and medical record review.
Month 3
Rate of antibiotic-complications
Zeitfenster: Month 6
The proportion of participants experiencing ≥1 antibiotic-related complication during treatment will be assessed. Complications include clinically significant events attributable to antibiotic exposure (e.g., allergic reactions, gastrointestinal intolerance, hepatotoxicity, nephrotoxicity, hematologic abnormalities, or local administration-related reactions). Events will be identified through clinical assessment, laboratory data, and medical record review.
Month 6
Rate of antibiotic-complications
Zeitfenster: Month 12
The proportion of participants experiencing ≥1 antibiotic-related complication during treatment will be assessed. Complications include clinically significant events attributable to antibiotic exposure (e.g., allergic reactions, gastrointestinal intolerance, hepatotoxicity, nephrotoxicity, hematologic abnormalities, or local administration-related reactions). Events will be identified through clinical assessment, laboratory data, and medical record review.
Month 12

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patient-Reported Outcomes Measurement Information System (PROMIS -29)
Zeitfenster: 2-weeks, 6-weeks, 3-months, 6-months, 12-months
The PROMIS-29 is a free to use, publicly available generic health related quality of life measure that includes seven domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. A 5-point Likert scale is used for each question and norm-based total scores (range 0-100) have been calculated so that 50 represents the mean and one standard deviation is 10 points. Higher scores represent better function.
2-weeks, 6-weeks, 3-months, 6-months, 12-months
Veterans RAND 12 (VR-12) Health Survey - Physical Component Score
Zeitfenster: 2-weeks, 6-weeks, 3-months, 6-months, 12-months
The VR-12 is a measure of global health that corresponds to seven domains: general health, physical functioning, role limitations, pain, fatigue, social functioning, and mental health. Together, these items are summarized into a Physical Component Score. The mean score is 50 with a standard deviation of 10. Higher scores indicate better average health (higher than 50 means better than average health, below 50 means below average health).
2-weeks, 6-weeks, 3-months, 6-months, 12-months
Veterans Rand 12 (VR12) Health Survey - Mental Component Score
Zeitfenster: 2 weeks, 6-weeks, 3-months, 6-months, 12-months
The VR-12 is a measure of global health that corresponds to seven domains: general health, physical functioning, role limitations, pain, fatigue, social functioning, and mental health. Together, these items are summarized into a Mental Component Score. The mean score is 50 with a standard deviation of 10. Higher scores indicate better average health (higher than 50 means better than average health, below 50 means below average health).
2 weeks, 6-weeks, 3-months, 6-months, 12-months
Pain - Numeric Rating Scale
Zeitfenster: 2-weeks, 6-weeks, 3-months, 6-months, 12-months
A scale from 0-10, where 0 is no pain and 10 is the worst pain.
2-weeks, 6-weeks, 3-months, 6-months, 12-months
Pain - Brief Pain Inventory (BPI)
Zeitfenster: 2-weeks, 6-weeks, 3-months, 6-months, 12-months
The BPI is a commonly used, validated 15-item measure of pain intensity and interference with daily life. There is a pain severity score and a pain interference score. Both are 0-10, with 0 being no pain and 10 being worst pain imaginable (for pain severity) and 0 being does not interfere and 10 being completely interfered (for pain interference). Lower scores are better.
2-weeks, 6-weeks, 3-months, 6-months, 12-months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Wake Forest University Health Sciences

Mitarbeiter

United States Department of Defense

Ermittler

  • Hauptermittler: Joseph R Hsu, MD, Wake Forest University Health Sciences

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2030

Studienabschluss (Geschätzt)

1. Dezember 2031

Studienanmeldedaten

Zuerst eingereicht

27. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Mai 2026

Zuerst gepostet (Tatsächlich)

2. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Juni 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB00147620
  • 40010222 (Andere Kennung: Department of Defense)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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