Osseointegration Infection
Conditions
Keywords
osseointegrated prostheses, infection, osseointegration
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.
Detailed description
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.
Interventions
PROCEDUREintraosseous 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.
Sponsors
Wake Forest University Health Sciences
United States Department of Defense
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Develop Wound Dehiscence | 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. |
| Number of Patients Who Develop Superficial Infection | 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. |
| Number of Patients Who Develop Deep Surgical Site Infection | 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. |
| Number of Patients With Treatment Failure | 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. |
| Rate of Adverse Events | 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. |
| Rate of antibiotic-complications | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS -29) | 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. |
| Veterans RAND 12 (VR-12) Health Survey - Physical Component Score | 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). |
| Veterans Rand 12 (VR12) Health Survey - Mental Component Score | 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). |
| Pain - Numeric Rating Scale | 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. |
| Pain - Brief Pain Inventory (BPI) | 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. |
Countries
United States
Contacts
CONTACTChristine Churchill, MA
PRINCIPAL_INVESTIGATORJoseph R Hsu, MD
Wake Forest University Health Sciences
Outcome results
None listed