Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AO Trauma North America | UNKNOWN |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2D Fluoroscopy then 3D Fluoroscopy | Experimental | 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". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2D Fluoroscopy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately at the time of 3D Fluoroscopy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joshua L Gary, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas at Health Science Center at Houston | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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". |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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". |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Immediately at the time of 3D Fluoroscopy |
|
Through the time of hospitalization (about 1 day after the procedure)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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". |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Gary, MD | The University of Texas Health Science Center at Houston | 713-486-6500 | Joshua.L.Gary@uth.tmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2017 | Aug 20, 2019 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 3D Fluoroscopy | Device | 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. |
|
| Immediately at the time of 3D Fluoroscopy |
| Pain as Assessed by the AOFAS Score | The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores | 3 months after 3D Fluoroscopy |
| Function as Assessed by the AOFAS Score | The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores | 3 months after 3D Fluoroscopy |
| Alignment as Assessed by the AOFAS Score | The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores | 3 months after 3D Fluoroscopy |
| Pain as Assessed by the AOFAS Score | The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores | 6 months after 3D Fluoroscopy |
| Function as Assessed by the AOFAS Score | The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores | 6 months after 3D Fluoroscopy |
| Alignment as Assessed by the AOFAS Score | The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores | 6 months after 3D Fluoroscopy |
| Pain as Assessed by the PROMIS Score | Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures | 3 months after 3D Fluoroscopy |
| Function as Assessed by the PROMIS Score | Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures | 3 months after 3D Fluoroscopy |
| Pain as Assessed by the PROMIS Score | Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures | 6 months after 3D Fluoroscopy |
| Function as Assessed by the PROMIS Score | Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures | 6 months after 3D Fluoroscopy |
| 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 | 1 day after 3D Fluoroscopy |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 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. | Posted | Count of Participants | Participants | Immediately at the time of 3D Fluoroscopy |
|
|
|
| Secondary | Pain as Assessed by the AOFAS Score | The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores | Data was not collected for this outcome measure. | Posted | 3 months after 3D Fluoroscopy |
|
|
| Secondary | Function as Assessed by the AOFAS Score | The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores | Data was not collected for this outcome measure. | Posted | 3 months after 3D Fluoroscopy |
|
|
| Secondary | Alignment as Assessed by the AOFAS Score | The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores | Data was not collected for this outcome measure. | Posted | 3 months after 3D Fluoroscopy |
|
|
| Secondary | Pain as Assessed by the AOFAS Score | The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores | Data was not collected for this outcome measure. | Posted | 6 months after 3D Fluoroscopy |
|
|
| Secondary | Function as Assessed by the AOFAS Score | The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores | Data was not collected for this outcome measure. | Posted | 6 months after 3D Fluoroscopy |
|
|
| Secondary | Alignment as Assessed by the AOFAS Score | The patient outcome variables studied will include American Orthopedic Foot and Ankle Society (AOFAS) scores | Data was not collected for this outcome measure. | Posted | 6 months after 3D Fluoroscopy |
|
|
| Secondary | Pain as Assessed by the PROMIS Score | Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures | Data was not collected for this outcome measure. | Posted | 3 months after 3D Fluoroscopy |
|
|
| Secondary | Function as Assessed by the PROMIS Score | Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures | Data was not collected for this outcome measure. | Posted | 3 months after 3D Fluoroscopy |
|
|
| Secondary | Pain as Assessed by the PROMIS Score | Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures | Data was not collected for this outcome measure. | Posted | 6 months after 3D Fluoroscopy |
|
|
| Secondary | Function as Assessed by the PROMIS Score | Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures | Data was not collected for this outcome measure. | Posted | 6 months after 3D Fluoroscopy |
|
|
| 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 | Posted | Count of Participants | Participants | 1 day after 3D Fluoroscopy |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
Not provided
Not provided
Not provided