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Intraosseous Antibiotics for Osseointegration (IOAOI)

2026년 6월 9일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

100

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Observational
Patients that do not require surgery for infection
실험적: Intraosseous Antibiotics for Osseointegration
Patients that require surgery for infection
절차: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Patients Who Develop Wound Dehiscence
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Patient-Reported Outcomes Measurement Information System (PROMIS -29)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Wake Forest University Health Sciences

협력자

United States Department of Defense

수사관

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

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2030년 12월 1일

연구 완료 (추정된)

2031년 12월 1일

연구 등록 날짜

최초 제출

2026년 5월 27일

QC 기준을 충족하는 최초 제출

2026년 5월 27일

처음 게시됨 (실제)

2026년 6월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 9일

마지막으로 확인됨

2026년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IRB00147620
  • 40010222 (기타 식별자: Department of Defense)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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