NCT07621094

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
64mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

June 11, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

May 27, 2026

Last Update Submit

June 9, 2026

Conditions

Osseointegration Infection

Keywords

osseointegrated prosthesesinfectionosseointegration

Outcome Measures

Primary Outcomes (30)

  • Number of Patients Who Develop Wound Dehiscence

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

Secondary Outcomes (5)

  • Patient-Reported Outcomes Measurement Information System (PROMIS -29)

    2-weeks, 6-weeks, 3-months, 6-months, 12-months

  • Veterans RAND 12 (VR-12) Health Survey - Physical Component Score

    2-weeks, 6-weeks, 3-months, 6-months, 12-months

  • Veterans Rand 12 (VR12) Health Survey - Mental Component Score

    2 weeks, 6-weeks, 3-months, 6-months, 12-months

  • Pain - Numeric Rating Scale

    2-weeks, 6-weeks, 3-months, 6-months, 12-months

  • Pain - Brief Pain Inventory (BPI)

    2-weeks, 6-weeks, 3-months, 6-months, 12-months

Study Arms (2)

Observational

NO INTERVENTION

Patients that do not require surgery for infection

Intraosseous Antibiotics for Osseointegration

EXPERIMENTAL

Patients that require surgery for infection

Procedure: intraosseous antibiotic delivery

Interventions

intraosseous antibiotic deliveryPROCEDURE

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.

Intraosseous Antibiotics for Osseointegration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Infections

Study Officials

  • Joseph R Hsu, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Churchill, MA

CONTACT

704-355-6947Christine.Churchill@advocatehealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 2, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2031

Last Updated

June 11, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(5)