Displaced Ankle Fractures
Conditions
Keywords
3D Fluoroscopy
Brief summary
The purpose of this study is to determine if use of new imaging technology termed 3D fluoroscopy will lead the surgeon to change the position of the fractured bones to a more accurate position.
Interventions
DEVICE2D Fluoroscopy
Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers et al i.e. 2D Fluoroscopy using device Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system.
DEVICE3D Fluoroscopy
After the attending surgeon is satisfied with the reduction quality from 2D Fluoroscopy, 3D fluoroscopy using device Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system will be used to generate additional images to assess syndesmotic and fibular reductions.
Sponsors
AO Trauma North America
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Skeletally mature * Patients with unilateral, acute, displaced ankle fractures with preoperative evidence of syndesmotic disruption or intraoperative evidence of syndesmotic instability following malleolar fixation.
Exclusion criteria
* Patients skeletally immature; * Patients less than age 18 years and more than age 75; * Patients with previous ankle trauma to either ankle; * Patients with bilateral ankle injuries; * Patients with previous osseous injuries to the tibia or fibula; and * Patients with isolated syndesmotic injury and no fracture (i.e. high ankle sprains)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants for Which the Surgeon Changed Reduction of Syndesmotic Reduction Because of Information Provided by 3D Fluoroscopy | Immediately at the time of 3D Fluoroscopy | Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers (2D Fluoroscopy). After the attending surgeon is satisfied with the reduction quality, 3D fluoroscopy will be used to generate additional images to assess syndesmotic reductions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain as Assessed by the AOFAS Score | 3 months after 3D Fluoroscopy | The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores |
| Function as Assessed by the AOFAS Score | 3 months after 3D Fluoroscopy | The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores |
| Alignment as Assessed by the AOFAS Score | 3 months after 3D Fluoroscopy | The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores |
| Number of Participants for Which the Surgeon Changed Reduction of Fibular Fracture Reduction Because of Information Provided by 3D Fluoroscopy | Immediately at the time of 3D Fluoroscopy | Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers (2D Fluoroscopy). After the attending surgeon is satisfied with the reduction quality, 3D fluoroscopy will be used to generate additional images to assess fibular fracture reductions. |
| Function as Assessed by the PROMIS Score | 3 months after 3D Fluoroscopy | Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures |
| Number of Participants With Syndesmotic Malreduction as Assessed by a Single Postoperative Bilateral CT Scan | 1 day after 3D Fluoroscopy | Malreduction will be determined by comparing uninjured ankle to the injured ankle |
| Pain as Assessed by the PROMIS Score | 3 months after 3D Fluoroscopy | Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2D Fluoroscopy Then 3D Fluoroscopy Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers et al (2D Fluoroscopy). After the attending surgeon is satisfied with the reduction quality, 3D fluoroscopy will be used to generate additional images to assess syndesmotic and fibular reductions. Both 2D and 3D Fluoroscopy will be performed using device Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | 2D Fluoroscopy Then 3D Fluoroscopy |
|---|---|
| Age, Continuous | 39 years |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black | 10 Participants |
| Race/Ethnicity, Customized Hispanic | 12 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants |
| Race/Ethnicity, Customized White | 5 Participants |
| Region of Enrollment United States | 30 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Number of Participants for Which the Surgeon Changed Reduction of Syndesmotic Reduction Because of Information Provided by 3D Fluoroscopy
Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers (2D Fluoroscopy). After the attending surgeon is satisfied with the reduction quality, 3D fluoroscopy will be used to generate additional images to assess syndesmotic reductions.
Time frame: Immediately at the time of 3D Fluoroscopy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2D Fluoroscopy Then 3D Fluoroscopy | Number of Participants for Which the Surgeon Changed Reduction of Syndesmotic Reduction Because of Information Provided by 3D Fluoroscopy | 14 Participants |
Secondary
Alignment as Assessed by the AOFAS Score
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Time frame: 6 months after 3D Fluoroscopy
Population: Data was not collected for this outcome measure.
Secondary
Alignment as Assessed by the AOFAS Score
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Time frame: 3 months after 3D Fluoroscopy
Population: Data was not collected for this outcome measure.
Secondary
Function as Assessed by the AOFAS Score
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Time frame: 6 months after 3D Fluoroscopy
Population: Data was not collected for this outcome measure.
Secondary
Function as Assessed by the AOFAS Score
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Time frame: 3 months after 3D Fluoroscopy
Population: Data was not collected for this outcome measure.
Secondary
Function as Assessed by the PROMIS Score
Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures
Time frame: 3 months after 3D Fluoroscopy
Population: Data was not collected for this outcome measure.
Secondary
Function as Assessed by the PROMIS Score
Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures
Time frame: 6 months after 3D Fluoroscopy
Population: Data was not collected for this outcome measure.
Secondary
Number of Participants for Which the Surgeon Changed Reduction of Fibular Fracture Reduction Because of Information Provided by 3D Fluoroscopy
Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers (2D Fluoroscopy). After the attending surgeon is satisfied with the reduction quality, 3D fluoroscopy will be used to generate additional images to assess fibular fracture reductions.
Time frame: Immediately at the time of 3D Fluoroscopy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2D Fluoroscopy Then 3D Fluoroscopy | Number of Participants for Which the Surgeon Changed Reduction of Fibular Fracture Reduction Because of Information Provided by 3D Fluoroscopy | 0 Participants |
Secondary
Number of Participants With Syndesmotic Malreduction as Assessed by a Single Postoperative Bilateral CT Scan
Malreduction will be determined by comparing uninjured ankle to the injured ankle
Time frame: 1 day after 3D Fluoroscopy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2D Fluoroscopy Then 3D Fluoroscopy | Number of Participants With Syndesmotic Malreduction as Assessed by a Single Postoperative Bilateral CT Scan | 3 Participants |
Secondary
Pain as Assessed by the AOFAS Score
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Time frame: 3 months after 3D Fluoroscopy
Population: Data was not collected for this outcome measure.
Secondary
Pain as Assessed by the AOFAS Score
The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores
Time frame: 6 months after 3D Fluoroscopy
Population: Data was not collected for this outcome measure.
Secondary
Pain as Assessed by the PROMIS Score
Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures
Time frame: 3 months after 3D Fluoroscopy
Population: Data was not collected for this outcome measure.
Secondary
Pain as Assessed by the PROMIS Score
Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures
Time frame: 6 months after 3D Fluoroscopy
Population: Data was not collected for this outcome measure.