Intraoperative fluorescence angiography for Fractures, Open

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Vanderbilt Orthopaedics, Nashville, TN
Fractures, Open+1 More
Intraoperative fluorescence angiography - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new imaging technique can help surgeons remove bone fragments more quickly.

See full description

Eligible Conditions

  • Fractures, Open
  • Intraoperative Fluorescence Angiography

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Intraoperative fluorescence angiography will improve 1 primary outcome in patients with Fractures, Open. Measurement will happen over the course of Intraoperative.

Intraoperative
Additional debridement following IFA use

Trial Safety

Trial Design

1 Treatment Group

Intraoperative fluorescence angiography
1 of 1
Experimental Treatment

This trial requires 20 total participants across 1 different treatment group

This trial involves a single treatment. Intraoperative Fluorescence Angiography is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Intraoperative fluorescence angiography
Device
Intraoperative fluorescence angiography will be utilized to view initial debridement area. Using a sterile marking pen, the surgeon will mark the areas of tissue on skin, subcutaneous tissue, muscle, bone, or other that he or she wishes to debride further due to poor perfusion. A reference point on uninjured tissue of the same extremity at least 10 cm from the wound will be identified and measured for perfusion (set to reference of 100% perfusion). The area to be further debrided will be measured for percent perfusion relative to this reference point.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: intraoperative
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly intraoperative for reporting.

Who is running the study

Principal Investigator
J. M.
Prof. Jed Maslow, Assistant Professor of Orthopaedic Surgery
Vanderbilt University Medical Center

Closest Location

Vanderbilt Orthopaedics - Nashville, TN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
All adults ≥18 years old
Open type II or type III upper or lower extremity fracture to be treated at Vanderbilt University Medical Center with operative intervention by orthopaedic trauma or orthopaedic hand surgeons.

Patient Q&A Section

What is fractures, open?

"Fractures, open may be an effective form of treating unstable spine fractures when there is an absence of bleeding from the injured area of the spine." - Anonymous Online Contributor

Unverified Answer

What are the signs of fractures, open?

"A combination of the signs and symptoms of fractures, open can be helpful in determining the likelihood of a fracture open and its correct cause." - Anonymous Online Contributor

Unverified Answer

What are common treatments for fractures, open?

"Findings from a recent study indicates that the frequency of common fractured treatment methods is highly variable. This is possibly due to the fact that the data were obtained retrospectively, and it is possible that in clinical practice the methods used are different according to the type of fracture, the age of the person at the time of the fracture, and the preferences of the health provider. A prospective study with patients' choice of treatment is necessary to help define the actual treatment of individuals with fractured bones." - Anonymous Online Contributor

Unverified Answer

How many people get fractures, open a year in the United States?

"1.2 million people, 8.6% of total number of fracture patients encountered in the emergency department each year. It is also important to note that about 5% of patients present with a fractured spine." - Anonymous Online Contributor

Unverified Answer

Can fractures, open be cured?

"Most people with fractures, open can be effectively treated and get better with appropriate medical care. The best management method for fractures, open is a simple, multi-staged treatment of fractures with external fixation of the unstable fracture with temporary external splinting of the displaced fracture components. For patients with multiple high-energy fractures, or fractures at the proximal femur, or fractures with open tibial plafond or apertures, treatment should begin with fixation of the fracture using a splint or temporary external fixation. After the fracture has been appropriately stabilized, immobilization and healing are achieved with an appropriate antibiotic and physical therapy." - Anonymous Online Contributor

Unverified Answer

What causes fractures, open?

"Data from a recent study suggests that many fractures in the elderly result from falls from standing positions, especially in women. Fractures are less likely to be caused by motor vehicle traffic injuries or by heavy industrial work in men in the older age group. Children rarely have fractures because their bones lack the dense cortical bone of adults. Fractures are usually associated with osteoporosis and osteopenia. Fractures rarely occur in individuals with normal bone density who have been screened for underlying causes of osteoporosis; most are due to benign conditions such as osteomalacia and osteitis pubis." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for fractures, open?

"Patients under 75 are at the highest risk of bias from clinical trial design in fracture studies, especially at the end stages of treatment, because their fracture experience is often poor compared with people older than 75. Given these findings, all fracture trials are recommended as clinical utility for all age groups, and studies in people aged older than 75 are recommended to include outcomes that will define patient benefit, rather than outcomes that are based on surrogate end points." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of intraoperative fluorescence angiography?

"Intraoperative angiography causes mild pain and mild nausea in a minority of cases, which can easily be managed if a thorough search for an anatomical relationship is made beforehand." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving intraoperative fluorescence angiography?

"Because of the lack of previous studies on the clinical usefulness of intraoperative fluorescence angiography in patients with fracture, many surgeons and orthopedists are reluctant to perform the procedure." - Anonymous Online Contributor

Unverified Answer

How does intraoperative fluorescence angiography work?

"Fluorescent angiography does not improve operative strategy in this preliminary study: intraoperative angiography can be predicted by intraoperative Doppler sonography using a cut-off of 1.8 cm/s to predict arterio-venous (AV) fistula in elective spine surgery." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of fractures, open?

"Patients have an increased risk for fractures that are related to the types of injuries that arise from assaults such as motor vehicle crashes and interpersonal violence when compared to patients who do not have a history of injuries from assault. The increased risk for fractures associated with assault injuries is greatest in patients who are hospitalized for other injuries." - Anonymous Online Contributor

Unverified Answer

Is intraoperative fluorescence angiography safe for people?

"For people undergoing lower limb fracture fixation, IA provides reliable visualization of the proximal femur, but the accuracy of visualization can be compromised by the presence of osteoporotic or maligned fractures around the time of the procedure." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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