Does Intraoperative 3D Fluoroscopy Accurately Assess Syndesmotic Reduction Following Traumatic Ankle Injury?
Phase: NA
Conditions: Displaced Ankle Fractures
Sponsor: The University of Texas Health Science Center, Houston

IRB NUMBER: HSC-MS-16-0840 
IRB APPROVAL DATE: 08/04/2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Does Intraoperative 3D Fluoroscopy Accurately Assess Syndesmotic Reduction Following 
Traumatic Ankle Injury? 
 
NCT03163017 
 
Version Date: 08/04/2017 
 
 

IRB NUMBER: HSC-MS-16-0840 
IRB APPROVAL DATE: 08/04/2017 
 
 
 
 
 
 
 
 
 
Protocol Title: 
Does Intraoperative 3D Fluoroscopy Accurately Assess Syndesmotic 
Reduction Following Traumatic Ankle Injury? 
 
 
Principal Investigator: 
Joshua Gary, M.D. 
Department of Orthopedic Surgery 
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Co-Investigators: 
Bryce Cunningham, M.D., PGY-6, Orthopedic Trauma Fellow 
Stephen Warner, M.D., PGY-6, Orthopedic Trauma Fellow 
Steven Cherney, M.D., PGY-6, Orthopedic Trauma Fellow 
 
Population: 
All patients of age 18-75 who are skeletally mature, and have unilateral, acute, 
displaced ankle fractures with preoperative evidence of syndesmotic disruption 
or intraoperative evidence of syndesmotic instability following malleolar 
fixation. 
 
Site: 
UT Houston – Texas Medical Center 
 
Site Address: 
University of Texas Health Science Center – Houston 
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Study Duration: 
October 1, 2016 through October 1, 2017 

IRB NUMBER: HSC-MS-16-0840 
IRB APPROVAL DATE: 08/04/2017 
 
 
 
Abstract 
Injury to the ankle syndesmosis is commonly associated with rotational ankle fractures, occurring in 
23-52% of cases1-4. Accurate syndesmotic reduction and stabilization of the ankle mortise has been 
shown to correlate with improved functional outcomes in these patients1,4,5. Despite multiple 
techniques to improve reduction accuracy, syndesmotic malreduction remains common1,6. Use of the 
contralateral, uninjured ankle as a template for the reduction of the injured ankle syndesmosis by 
Summers et. al has shown the lowest malreduction rate of 6% (1 / 18 patients), however, CT scan of 
the uninjured ankle was not used as comparison7. Use of intraoperative CT scans can also reduce the 
rate of syndesmotic malreduction but can be cumbersome and is often unavailable or unfamiliar to 
the surgeon8. Intraoperative 3-dimensional fluoroscopy is new technology that isometrically focuses 
on a single point and can generate CT scan-like images, yet operates like a conventional C-arm. 
This prospective, observational study will enroll patients with unilateral, unstable, rotational ankle 
fractures with preoperative or intraoperative evidence of syndesmotic instability to assess ability of 
3D fluoroscopy to aid in accurate syndesmotic reduction. 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 Summers7. 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. The number of times that the surgeon changes the reduction of 
either the syndesmosis reduction (primary outcome) or fibular fracture reduction (secondary 
outcome) because of information provided by 3D fluoroscopy will be recorded. Fixation of the 
syndesmosis by screw or suture button device will then be performed according to surgeon 
preference in a standard fashion. A limited postoperative bilateral ankle CT scan will be performed to 
assess the accuracy of reduction. 

IRB NUMBER: HSC-MS-16-0840 
IRB APPROVAL DATE: 08/04/2017 
 
 
Research Question 
Can intraoperative 3D fluoroscopic technology accurately assess syndesmotic reduction in operative 
acute ankle fractures and fracture-dislocations with associated syndesmotic injury and does it lead the 
surgeon to alter the reduction after using the standard technique of comparison fluoroscopic images 
of the contralateral, uninjured ankle? 
Hypothesis 
We hypotheses that intraoperative 3D fluoroscopy will frequently lead the surgeon to change the 
reduction of the syndesmosis and/or fibular fracture and that the use of novel 3D fluoroscopy 
technology will yield a low rate of syndesmotic malreduction. 
Specific Aims 
Specific aim #1: Identify the frequency where intraoperative 3D fluoroscopy leads to a change in the 
syndesmotic reduction after using the standard technique of contralateral ankle fluoroscopic imaging 
by Summers et al7. 
Specific aim #2: Describe use of 3D fluoroscopy in assessment of ankle and syndesmotic reduction 
quality to the orthopedic community. 
Specific aim #3: Ascertain patient functional outcomes using Patient-Reported Outcomes 
Measurement Information System (PROMIS) physical health outcomes on patients at 6 month 
follow-up. 
Relevance to the current orthopaedic trauma literature 
Despite numerous publications documenting persistent syndesmotic malreduction following acute 
ankle trauma, a gold standard technique is yet to exist for intraoperative assessment of syndesmotic 
reduction. Currently, the technique used most commonly by the orthopedic community is use of 
comparison contralateral (uninjured) radiographs to assess fibular length, rotation, and syndesmotic 
reduction. Some authors suggest direct open visualization of the syndesmotic reduction at the time of 
fixation. This pilot study aims to describe the use of 3D fluoroscopy and feasibility of use 
intraoperatively for acute ankle syndesmotic injury. 
Methods 
Study design: 
A prospective, observational study proposes to enroll patients with unilateral, unstable, rotational 
ankle fractures with preoperative or intraoperative evidence of syndesmotic instability to assess 
ability of 3D fluoroscopy to aid in accurate syndesmotic reduction. 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 Summers7. 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. The number of times that the surgeon changes the 
reduction of either the syndesmosis reduction (primary outcome) or fibular fracture reduction 

IRB NUMBER: HSC-MS-16-0840 
IRB APPROVAL DATE: 08/04/2017 
 
 
(secondary outcome) because of information provided by 3D fluoroscopy will be recorded. Fixation 
of the syndesmosis by screw or suture button device will then be performed according to surgeon 
preference in a standard fashion. A single postoperative bilateral ankle CT scan will be performed to 
judge the accuracy of the injured ankle reduction to the uninjured ankle, the current gold 
standard. The patient outcome variables studied will include American Orthopedic Foot and Ankle 
Society (AOFAS) scores at 3 and 6 months as well as use of PROMIS patient physical health 
outcome measures using the Research Electronic Data Capture (REDCap) software survey system. 
Subjects unable to return to clinic for their 3 and 6 month follow-up visits will be asked to complete 
the AOFAS over the phone with the researcher. At that time, they will be asked for their e-mail 
address and sent a link to complete the PROMIS survey. 
Study Subjects: 
Inclusion criteria 
• 
Patients 18-75 years of age, skeletally mature; and 
• 
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) 
 
 
Sample Size: 
 
In 2015, 40 patients were treated operatively for a syndesmotic disruption at Memorial Hermann 
Hospital. For patient enrollment collection over 8-9 months, the estimated sample size is 30 patients. 
 
Data Collection / Handling: 
Data will be collected and maintained by research personnel, residents, fellows, and faculty from the 
Department of Orthopaedic Surgery. The orthopedic trauma fellow (B.C.) will be primarily 
responsible for data handling and storage. Data will be stored in locked departmental research 
facilities and on password-protected networks and devices of departmental research personnel and 
residents. When the data collection is complete, patient identifiers will be removed prior to the 
sharing of data for statistical consult and analysis. 

IRB NUMBER: HSC-MS-16-0840 
IRB APPROVAL DATE: 08/04/2017 
 
 
 

IRB NUMBER: HSC-MS-16-0840 
IRB APPROVAL DATE: 08/04/2017 
 
 
Data Analysis: 
Injury radiographs and intraoperative fluoroscopy will be reviewed by the orthopedic trauma fellows 
and fellowship-trained orthopedic traumatologists to identify patients with acute syndesmotic 
instability in association with ankle fractures. 
Statistical analysis will be performed using Microsoft Excel and SPSS. Continuous variables will be 
presented as a range, with mean and standard deviation. Categorical variables will be expressed as 
percentages. Logistic regression and multivariate analysis may be used to assess significant 
associations between predictor variables. A p value of <0.05 will be used for the significance testing. 
Time Schedule 
1) Complete IRB review process - September 2016 
2) Execution through sponsored projects administration – October 2016 
3) Start patient enrollment – November 1, 2016 
4) Patient enrollment November 1, 2016 – July 1, 2016 
5) Data analysis July 2017 
6) Submission for publication September 2017 
Risks 
Use of 3D fluoroscopy is increasingly used at Hermann Memorial Hospital for treatment of 
orthopedic trauma patients. It may lead to slightly increased total radiation dosage delivered to the 
patient compared to the current technique using 2D fluoroscopy. There is additional radiation 
exposure to the ankles and feet from the postoperative CT scan. 
Benefits 
This novel technology is beginning to be used in orthopedic trauma to improve 3-dimensional 
understanding of complex injures. This study may lead to improved syndesmotic reduction and 
possibly improved patient reported functional outcomes. 
Budget: 
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IRB NUMBER: HSC-MS-16-0840 
IRB APPROVAL DATE: 08/04/2017 
 
 
References 
1) Miller AN, Barei DP, et al. Iatrogenic syndesmosis malreduction via clamp and screw placement. 
JOT 2013; 27: 100-106. 
2) Koenig SJ, Tornetta P, et al. Can we tell if the syndesmosis is reduced using fluoroscopy? JOT 
2015; 29: e326-30. 
3) Cherney SM, Haynes JA, et al. In vivo syndesmotic overcompression after fixation of ankle 
fractures with a syndesmotic injury. JOT 2015; 29: 414-19. 
4) Van Heest TJ and PM Lafferty. Injuries to the ankle syndesmosis. JBJS 2014; 96: 603-13. 
5) Sagi HC, Shah AR, et al. The functional consequences of syndesmotic joint malreduction at a 
minimum 2-year follow-up. JOT 2012; 26: 439-43. 
6) Miller AN, Carroll EA, et al. Direct visualization for syndesmotic stabilization of ankle fractures. 
Foot ankle int 2009; 30: 419-26. 
7) Summers HD, Sinclair MK, et al. A reliable method for intraoperative evaluation of syndesmotic 
reduction. JOT 2013; 27: 196-200. 
8) Lepojarvi S, Pakarinen H, et al. Posterior translation of the fibula may indicate malreduction: CT 
study of normal variation in uninjured ankles. JOT 2014; 28: 205-9. 
9) Dikos GD, Heisler J, et al. Normal tibiofibular relationships at the syndesmosis on axial CT 
imaging. JOT 2012; 26: 433-8.