Displaced Ankle FracturesNCT03163017
Assessment of Ability of 3D Fluorscopy in Aiding Accurate Syndesmotic Reduction Following Traumatic Ankle Injury
A study testing 2D Fluoroscopy and 3D Fluoroscopy in people with Displaced Ankle Fractures, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Displaced Ankle Fractures
- What is being tested?
- 2D Fluoroscopy and 3D Fluoroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 11 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletally mature
- Patients with unilateral, acute, displaced ankle fractures with preoperative evidence of syndesmotic disruption or intraoperative evidence of syndesmotic instability following malleolar fixation.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Does Intraoperative 3D Fluoroscopy Accurately Assess Syndesmotic Reduction Following Traumatic Ankle Injury?
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.
- Conditions
- Displaced Ankle Fractures
- Being tested
- 2D Fluoroscopy, 3D Fluoroscopy
- Keywords
- 3D Fluoroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D FluoroscopyDevice
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.
3D FluoroscopyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: Device: 2D Fluoroscopy; Device: 3D Fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately at the time of 3D Fluoroscopy
Secondary outcomes (12)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months after 3D Fluoroscopy
Pain as Assessed by the PROMIS Score
Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures
Measured: 3 months after 3D Fluoroscopy
Function as Assessed by the PROMIS Score
Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures
Measured: 3 months after 3D Fluoroscopy
Pain as Assessed by the PROMIS Score
Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures
Measured: 6 months after 3D Fluoroscopy
Function as Assessed by the PROMIS Score
Patient-Reported Outcomes Measurement Information System (PROMIS) patient physical health outcome measures
Measured: 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
Measured: 1 day after 3D Fluoroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start1 Mar 2017
- Primary completion11 Sep 2018
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Displaced Ankle FracturesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AO Trauma North America
- Responsible party
- Principal investigator, Joshua L Gary, The University of Texas Health Science Center, Houston
- Investigators
- Joshua L Gary, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163017
- Sponsor's protocol ID
- HSC-MS-16-0840
- Status last verified
- Aug 2019
- First submitted
- 19 May 2017
- Last updated
- 12 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intraoperative 3D Fluoroscopy Accurately Assess Syndesmotic Reduction Following Traumatic Ankle Injury?
- ClinicalTrials.gov ID
- NCT03163017
- Acronym / sponsor ID
- HSC-MS-16-0840
- Conditions
- Displaced Ankle Fractures
- Keywords
- 3D Fluoroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- AO Trauma North America
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Posted 12 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2D Fluoroscopy then 3D Fluoroscopy | Experimental | Device: 2D Fluoroscopy, Device: 3D FluoroscopyPatients 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". |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Skeletally mature
- Patients with unilateral, acute, displaced ankle fractures with preoperative evidence of syndesmotic disruption or intraoperative evidence of syndesmotic instability following malleolar fixation.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2D FluoroscopyPatients 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. | Device | 2D Fluoroscopy then 3D Fluoroscopy |
| 3D FluoroscopyAfter 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. | Device | 2D Fluoroscopy then 3D Fluoroscopy |
Primary outcome
Number of Participants for Which the Surgeon Changed Reduction of Syndesmotic Reduction Because of Information Provided by 3D Fluoroscopy
Time frame: 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.
12 secondary outcomes
Number of Participants for Which the Surgeon Changed Reduction of Fibular Fracture Reduction Because of Information Provided by 3D Fluoroscopy
Time frame: Immediately at the time of 3D Fluoroscopy
Pain as Assessed by the AOFAS Score
Time frame: 3 months after 3D Fluoroscopy
Function as Assessed by the AOFAS Score
Time frame: 3 months after 3D Fluoroscopy
Alignment as Assessed by the AOFAS Score
Time frame: 3 months after 3D Fluoroscopy
Pain as Assessed by the AOFAS Score
Time frame: 6 months after 3D Fluoroscopy
Function as Assessed by the AOFAS Score
Time frame: 6 months after 3D Fluoroscopy
Alignment as Assessed by the AOFAS Score
Time frame: 6 months after 3D Fluoroscopy
Pain as Assessed by the PROMIS Score
Time frame: 3 months after 3D Fluoroscopy
Function as Assessed by the PROMIS Score
Time frame: 3 months after 3D Fluoroscopy
Pain as Assessed by the PROMIS Score
Time frame: 6 months after 3D Fluoroscopy
Function as Assessed by the PROMIS Score
Time frame: 6 months after 3D Fluoroscopy
Number of Participants With Syndesmotic Malreduction as Assessed by a Single Postoperative Bilateral CT Scan
Time frame: 1 day after 3D Fluoroscopy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua L Gary, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2D Fluoroscopy and 3D Fluoroscopy in people with Displaced Ankle Fractures, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants for Which the Surgeon Changed Reduction of Syndesmotic Reduction Because of Information Provided by 3D Fluoroscopy (time frame: Immediately at the time of 3D Fluoroscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.