Intraosseous Antibiotics for Osseointegration

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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 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 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 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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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).

A scale from 0-10, where 0 is no pain and 10 is the worst pain.

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.