Displaced Ankle Fractures Clinical Trial
Official title:
Does Intraoperative 3D Fluoroscopy Accurately Assess Syndesmotic Reduction Following Traumatic Ankle Injury?
| Verified date | August 2019 |
| Source | The University of Texas Health Science Center, Houston |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | September 11, 2018 |
| Est. primary completion date | September 11, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | The University of Texas at Health Science Center at Houston | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Texas Health Science Center, Houston | AO Trauma North America |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | Immediately at the time of 3D Fluoroscopy | |
| 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 1 day after 3D Fluoroscopy |