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Intraosseous Antibiotics for Osseointegration (IOAOI)

9 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

100

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: Observational
Patients that do not require surgery for infection
Eksperymentalny: Intraosseous Antibiotics for Osseointegration
Patients that require surgery for infection
Procedura: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Patients Who Develop Wound Dehiscence
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Patient-Reported Outcomes Measurement Information System (PROMIS -29)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Wake Forest University Health Sciences

Współpracownicy

United States Department of Defense

Śledczy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 grudnia 2030

Ukończenie studiów (Szacowany)

1 grudnia 2031

Daty rejestracji na studia

Pierwszy przesłany

27 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

27 maja 2026

Pierwszy wysłany (Rzeczywisty)

2 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

11 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 czerwca 2026

Ostatnia weryfikacja

1 kwietnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • IRB00147620
  • 40010222 (Inny identyfikator: Department of Defense)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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