Trauma Injury
Conditions
Keywords
Trauma, Amputation, Orthopaedic, Lower Extremity
Brief summary
This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure.
Detailed description
This is a non-randomized prospective study of 30 patients scheduled to undergo lower extremity amputation (below the knee, through the knee or above the knee) evaluating bone perfusion and viability using indocyanine green (ICG) fluorescence imaging at several steps during surgical procedure. The data collected in this study will inform the development of methodology and thresholds around providing surgeons with objective data regarding critically injured bone in the setting of musculoskeletal trauma and/or bone infection. This will improve our management of and decrease variation associated with management of these disabling conditions.
Interventions
PROCEDURELower Extremity Amputation
patients 18 years of age or older who will have a planned lower leg (either below knee, through knee, or above knee) amputation surgery are scheduled to undergo a lower extremity amputation (either below knee, through knee or above knee), performed by a participating surgeon or delegate. Provision of informed consent.
Sponsors
Dartmouth College
Dartmouth-Hitchcock Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients 18 years of age or older 2. Scheduled for a lower extremity amputation (either below knee, through knee or above knee) 3. Provision of informed consent
Exclusion criteria
1. Iodine allergy 2. Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Bone Blood Flow (TBBF)-Post Osteotomy | 4 hours | Changes to total bone blood flow changes that occur as a result of osteotomy and soft tissue stripping associated with the amputationas will be assessed by immunofluorescence based dynamic constrast enhanced fluorescence imaging. |
| Total Bone Blood Flow (TBBF)-Post Osteotomy+Stripping | 4 hours | Changes to total bone blood flow changes that occur as a result of osteotomy and soft tissue stripping associated with the amputations will be assessed by immunofluorescence based dynamic contrast enhanced fluorescence imaging. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Extremity Amputation Patients over 18 undergoing either below knee, through knee, or above knee lower extremity amputation. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Extremity Amputation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 14 Participants |
| Total Bone Blood Flow | 6.7 mL/min/100g |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Total Bone Blood Flow (TBBF)-Post Osteotomy
Changes to total bone blood flow changes that occur as a result of osteotomy and soft tissue stripping associated with the amputationas will be assessed by immunofluorescence based dynamic constrast enhanced fluorescence imaging.
Time frame: 4 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Extremity Amputation | Total Bone Blood Flow (TBBF)-Post Osteotomy | 4.9 mL/min/100g |
Primary
Total Bone Blood Flow (TBBF)-Post Osteotomy+Stripping
Changes to total bone blood flow changes that occur as a result of osteotomy and soft tissue stripping associated with the amputations will be assessed by immunofluorescence based dynamic contrast enhanced fluorescence imaging.
Time frame: 4 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Extremity Amputation | Total Bone Blood Flow (TBBF)-Post Osteotomy+Stripping | 0.8 mL/min/100g |
Comparison: Kinetic parameters were assessed by Mann-Whitney U test in MATLAB Statistics and Machine Learning Toolbox. Receiver operating characteristic (ROC) analysis based on logistic regression was utilized, with one surgical condition versus the other two states as the binary dependent variable, and each perfusion-related kinetic parameter of Imax, IS and BF as the independent variable. Power analysis was performed to evaluate the statistical validity, using G\*Power softwarep-value: 0.05Regression, Logistic