Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair and Its Post-operative Effects on Syndesmotic Volumes: A Prospective, Single-blinded, Randomized Study
Phase: NA
Conditions: Syndesmotic Injuries, Ligament Rupture, Bimalleolar Fractures, Trimalleolar Fractures
Sponsor: Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists

Internal brace augmented anterior inferior tibiofibular ligament repair  
and its post-operative effects on syndesmotic volumes:  
A prospective, single-blinded, randomized study 
 
Principal Investigator:  
Blake Moore, MD 
 
Study Coordinators:   
Brice Snyder, MSAT, ATC, BCS-O 
 
 
 
 
(757) 679-3407 
 
 
 
 
Ashley Suttmiller, PhD, ATC 
 
Study Site:  
Vann-Virginia Center for Orthopaedics dba Alantic Orthopaedic  
Specialists 
Protocol ID:  
 
IIRR-01161 
 
Clinical Trial Registration:  NCT05062265 
 
 
 
 
 

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Internal brace augmented anterior inferior tibiofibular ligament repair and its post-
operative effects on syndesmotic volumes: A prospective, single-blinded, randomized study 
 
1. BACKGROUND, OBJECTIVES, & STUDY DESIGN 
 
Ankle syndesmosis disruption due to ankle trauma is associated with significant pain and 
disability.1,2 Surgical stabilization procedures typically involve an internal fixation of the distal 
tibiofibular joint to restore the spatial relationship of the bony structures. Rigid fixation has 
traditionally been the technique of choice for stabilizing the syndesmosis; however, dynamic 
fixation options like the TightRope® system (Arthrex®, Naples, United States) have more 
recently demonstrated some advantage over rigid screw fixation techniques as they attempt to 
mimic the dynamic nature of the syndesmosis.3-6 Tightrope or flexible fixation is still a non-
anatomic reduction and stabilization technique and as such is only an approximation of the 
syndesmotic ligaments.  
Anterior inferior tibiofibular ligament (AITFL) augmentation techniques using 
nonabsorbable suture materials (InternalBrace, Arthrex®, Naples, United States) have been used 
to supplement syndesmotic fixation in order to more accurately reconstruct the syndesmosis and 
restore native biomechanics.7,8 Clinical research assessing the use of the InternalBrace as an 
additional stabilization method is lacking and the minimum required stability to achieve 
successful clinical and patient-reported outcomes remains unclear.  
The primary objective of this study is to evaluate the quality of syndesmotic reduction as 
determined by weight bearing 3-D relative volumetric ratio between ankles in patients 
undergoing syndesmotic stabilization with and without an InternalBrace augmented repair of the 
AITFL to determine if the technique influences the reduction and postoperative stability of the 
syndesmosis. This will be compared at both 6-weeks and 3-months post-operation. Our 

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secondary objectives are 1) to determine whether the addition of the InternalBrace augmentation 
to the traditional TightRope fixation procedure improves short- and long-term patient-reported 
ankle function and generic health ratings and 2) to explore relationships between syndesmotic 
volume and patient-reported outcomes across groups.  
Design 
We will use a prospective, two-arm, single-blind, randomized study design to conduct 
our pilot study. After informed consent, twenty patients will be randomized evenly into a 
traditional TightRope fixation group or a TightRope fixation with an AITFL augmentation group 
upon enrollment into the study. As this is a pilot study with a small sample size, block 
randomization will be used to reduce the risk of unequal group sizes between groups. A 
researcher who will not otherwise be involved in patient interactions will serve as the 
randomization coordinator for this trial. They will prepare a randomization schedule using the 
freely accessible tools available at www.randomization.com. The sequence generator uses block 
randomization procedures based on the number of interventions and patients needed in each 
block and creates a schedule based on the patient ID number. Due to the potential emergent 
nature of injuries involved in this study and a short time between enrollment and surgery, the 
surgeon may need to acquire the group allocation shortly after enrolling patients to be able to 
prepare for the surgery and so the schedule will be converted to a Google Document that can 
then be accessed by the surgeon/PI to reveal the intervention allocation. Since pre-operative and 
post-operative instructions are the same regardless of the procedure, the participants will be 
blinded to their intervention group until the completion of the study period. 
Participant Population 

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Due to the nature of the study population needed, potential participants will be recruited 
from the clinic or corresponding hospital of the study doctor. Patients will be considered for 
inclusion in the study if they are over 18 years old and demonstrate unilateral ankle trauma 
causing syndesmotic disruption (e.g., ligamentous rupture, and/or bimalleolar and trimalleolar 
ankle fractures) and are determined to be good candidates for TightRope fixation surgery outside 
of the research context. Exclusion criteria is as follows: Illiterate patients, non-English speakers, 
minors, patients with diminished mental capacity, or any patient needing a legally authorized 
representative, pregnant patients, patients that have had a previous ankle surgery, have an open 
fracture, fractures that require posterolateral approach, or any contralateral foot or ankle injury. I 
Additionally, patients will also be excluded if they are unable to complete the CT scans 
necessary for completing the volumetric assessments, or if upon surgical exposure, the AITFL 
remains intact. In the case of the latter, the patients would still receive appropriate procedures 
necessary for treating their ankle trauma but would be excluded from the study.  
Participant Enrollment and/or Screening 
 
Patients will be identified in the clinic or hospital by the study doctor. Patients will be 
consented for syndesmotic open reduction surgery using the TightRope system which will 
indicate the patient for potential inclusion into the study. Patients will then be screened for 
exclusion criteria listed above and if no exclusion criteria are present, the patient would be 
considered for inclusion and the informed consent process would begin. 
Withdrawal of Subjects 
 
Participants will be withdrawn from the study if any of the following conditions exist: 
1. Participant voluntarily withdraws from the study 
2. Participant death 

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3. Participant who, in the opinion of the PI, would be compromised by continued study 
participation 
4. Participant experiences an AE that, in the opinion of the PI, necessitates removal 
from the study, including unresolved SAE or death 
5. Participant experiences an intercurrent illness, injury, or other reason that would, in 
the opinion of the PI, affect the assessment of clinical outcomes or the conduct of the 
study to a significant degree 
6. Participant fails to comply with protocol requirements 
7. Administrative reasons (e.g., PI decides to discontinue the study) 
Under these conditions, all patient data will be immediately destroyed. During the consent 
process, participants will be informed of their right to withdraw from the study at any time for 
any reason and without prejudice to alternative treatment. For subjects lost to follow-up, the 
research team should attempt to contact the patient via phone a minimum of three times before 
considering them lost to follow-up. Participants who withdraw voluntarily or are discontinued by 
the PI will remain eligible for standard of care treatment by the PI and research team. 
2. STUDY PROCEDURES 
Prospective patients will enter the clinic or hospital associated with the study doctor seeking 
care after ankle trauma. Patient will be moved through clinic/hospital workflow as normal. Once 
the patient elects to undergo syndesmotic stabilization surgery and is over 18 years of age, study 
protocol will be triggered as follows: 
1. The study doctor will do an initial clinical screening for open fractures or fractures that 
would require a posterolateral approach during his examination, and if present, the patient 
will be excluded. If patients are not excluded at this point, the study doctor or another 

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member of the research team will enter the room and work through the informed consent 
process with the goal of obtaining the consent. Patient will have ample opportunity to 
read through documents to their desire. Patient will be asked if they are literate and speak 
English comfortably and excluded if they do not answer yes to both questions.  
2. Once the consent is signed, a research team member will review patient’s medical history 
for presence of other exclusion factors: previous ankle surgery, or any contralateral foot 
or ankle injury. If any exclusion factor is present, consent documents will be shredded. 
3. If no exclusion factors are present at this point, the following will occur: 
a. The patient will be issued a participant ID number and will complete the pre-
operative patient-reported outcomes (PROs) related to their perceived ankle 
function (The Foot and Ankle Outcome Score) and generic health status (SF-36). 
These will be administered by a research team member by using either paper 
format, or a tablet computer through a survey administration software called 
Surgical Outcome System (SOS). 
b.  The participant ID will be used by the study doctor to verify their randomized 
group allocation schedule generated by block randomization procedures described 
above and will be scheduled for their respective surgery. 
4. Patient will follow typical pre-operative procedures. During the procedure, the patients 
will be in a supine position so that the fibula and the lateral ankle ligaments can be 
exposed. The integrity of the AITFL will be examined by the study doctor, and if 
disrupted the participant will be included in the study and will undergo either the 
traditional TightRope fixation procedure or the double stabilization procedure 
(TightRope fixation plus InternalBrace augmentation) as assigned and performed by the 

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study doctor. If AITFL disruption is not confirmed at this point, the patient will be 
excluded from the study; however, will still undergo the appropriate stabilization 
procedures necessary for treating their traumatic injury. If patients are excluded at this 
point, they will be informed post-operatively, and all study documents will be shredded.  
5. If participants are not excluded and are assigned to the traditional TightRope fixation 
group: the fibular fracture will be stabilized with fixation and the plate will be applied 
laterally to the fibula. The syndesmosis is directly reduced and held in a stable position 
with the TightRope device. The syndesmosis is then restressed and examined to ensure 
that it is stable and reduced.  
6. If participant is not excluded and is assigned to the TightRope fixation plus InternalBrace 
augmentation group: the FiberTape portion of the InternalBrace will be threaded through 
the distal fibular plate which will then be applied. The fibular fracture will be stabilized 
with fixation and the plate applied laterally to the fibula. The syndesmosis will be directly 
reduced and held in a stable position with the TightRope device. A 3.4 mm drill and 4.75 
mm tap are used to make a small hole in the distal tibia at the anatomic origin of the 
anterior inferior tibiofibular ligament. A 4.75 mm SwiveLock anchor is then used to set 
the tension of the AITFL repair over the top of the torn AITFL ligament. The 
syndesmosis is then restressed and examined to ensure that it is stable and reduced.  
7. Pre-operative PRO data for all eligible participants will be entered into a spreadsheet by a 
research team member along with basic demographic information (age, biological sex, 
height, weight, race), involved side (right or left ankle), type of procedure (traditional or 
traditional plus augmentation), and any relevant surgical notes.  

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8. All participants will be given the same post-operative directives regarding treatments and 
care which includes being non-weightbearing and immobilized for the first two weeks 
after surgery. At this point, the patients will begin a physical therapy program 
incorporating passive modalities and gentle range-of-motion exercises. Patients will 
remain non-weightbearing in a post-operative cam boot for the next 4-6 weeks. 
9. Participants will then return to the office for their 6-week and 3-month follow-up visits 
where they will complete the PROs and the bilateral WBCT using the CT Lineup 
(CurveBeam, Warrington, PA) which will be used to determine 3D syndesmotic volume. 
Participants will be followed throughout the remaining study period and will complete 
the PROs again at 6 months and 1 year post-operatively. PRO data will be entered into 
the study spreadsheet by a research team member after each of these follow-up visits. 
10. At the duration of the study period patients will receive the details of their surgery group 
to have for their records and knowledge.  
11. Deidentified data will be analyzed by one of the study coordinators (AS) at the 
completion of data collection. 
Consent Process and Documentation 
The study doctor or another research team member will complete the entire consent 
process. Potential participants will be identified in the clinic or hospital. Once the subject has 
signed the surgical consent, the study will be presented and explained to them. After receiving 
detailed information regarding the study, objectives, logistics, inclusion/exclusion criteria, risks 
and potential benefits, they can then choose to sign the consent form once all their questions 
have been answered. The signed consent form will represent documentation that the consent 
process took place. The documentation will be stored in a locked file cabinet in the secured 

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research office. Patient will be informed that: data will be kept in excel spreadsheets only 
accessible to authorized study personnel on password protected computers; Identifiers will be 
kept until the end of the study, and data will be destroyed at the soonest possible time; Identifiers 
and data will be kept for the study period and only necessary personnel will have access to data. 
3. OUTCOMES & DATA 
Primary Outcomes 
3D Syndesmotic Volume: Volumetric assessment of the distal syndesmosis will be 
performed with the WBCT using the CubeView software (CurveBeam, Warrington, PA). 
The software can calculate 3D volume amounts using cross-sectional imaging.9 
Measurements will start from the joint line and extend proximally,9-11 and will be 
performed by research staff blinded to the surgical procedure and trained by the study 
doctor. 
Patient-Reported Outcomes:  
• The Foot and Ankle Outcome Score (FAOS) will be used to assess participants’ 
perceived ankle function.12 It is a 42-item questionnaire with five subscales 
measuring pain, other symptoms including swelling, stiffness and range of motion, 
activities of daily living, sport and recreation, and foot and ankle-related quality of 
life and has demonstrated high internal consistency with subscales ranging from α = 
0.88-0.97, acceptable test-retest reliability, and validity.12 Items are scored on a 5-
point Likert scale from no to extreme. Scores are totaled for each subscale and 
transformed into percentages, with 100% being representative of no functional loss.  
• The SF-36 will be used to assess generic health ratings as it has demonstrated good 
reliability (ICC = 0.87) and construct validity.13 It is a 36-item questionnaire 

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assessing physical functioning, social functioning, role limitation caused by physical 
problems and emotional problems, bodily pain, mental health, energy, and general 
perceptions of overall health which combine to form the physical component 
summary (PCS) and the mental component summary (MCS).13 The norm-based 
standardized versions are based on a population mean of 50 and a standard deviation 
of 10 and will be used for analysis to allow for easy comparison with population 
norms. 
Adverse Events (AE) Definitions & Reporting 
The research team will collect all adverse events (AE) during the study from the time of 
enrollment until the patient exits the study. The following definitions are intended to assist the 
research team in the identification of AEs. The research team will follow applicable regulatory 
requirements to report AEs to regulatory authorities and to the IRB. 
Adverse Event (AE): An AE is any symptom, sign, illness or experience that develops or 
worsens in severity during the course of the study whether it is related or unrelated to the 
investigational device or its use. An AE need not be symptomatic to be reportable, e.g., 
device disruption detected on imaging that would require treatment, or psychological 
distress or discomfort associated with survey instruments. 
Serious Adverse Event (SAE): An SAE is any AE that is:  
• Fatal 
• Life threatening: the participant is at risk of death (could have died without 
intervention) at the time of the event. This does not apply to any hypothetical risk 
of death if the AE were more severe or were to progress. 
• Require or prolongs a hospital stay: Greater than 1 day (24 hours)  

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• Permanent impairment to a body structure or body function 
Relationship of AE to the study: The relationship of the AE to the study devices or 
procedures will be classified as either: 
• Related: The adverse event has a reasonable temporal relationship to the use of 
the device or the procedure and cannot reasonably be explained by known 
characteristics of the participant’s clinical state or other therapies. 
• Not Related: The adverse event is due to the underlying disease state or is due to 
concomitant medication or therapy not related to the use of the device. 
• Unknown: If the adverse event cannot be determined to have a causal 
relationship, it will be classified as unknown. 
Unanticipated: The sponsor is responsible for classifying AEs as anticipated or 
unanticipated according to the accepted regulatory definitions.  
The PI and research team will be responsible for ensuring participants’ safety daily and 
for the reporting of any SAEs and unanticipated AEs that are determined relevant to the devices 
or study procedures. For reportable events, the research team will follow applicable regulatory 
requirements to report the event to regulatory authorities and to the IRB immediately.  
Data and Safety Monitoring Plan 
Investigators and research staff will make every effort to maintain confidentiality. Once 
patients consent and are enrolled into the study they will be given a participant ID number that 
will be used to track and identify them for the remainder of study. Only those directly involved 
in the research will have access to the document matching the participant's name with participant 
ID number. Electronic data will be de-identified and stored on an encrypted and secured network 
drive which is only accessible to the research team. All paper files will be stored in a secured and 

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locked filing cabinet only accessible by research staff at 1975 Glenn Mitchell Dr, Suite #200 in 
the research office. 
All study personnel will be responsible for knowing the protocol and adhering to the 
protocol. Study personnel will self-check and review the protocol frequently to ensure they know 
it very well. If a study team member is found to deviate from the protocol, the member will be 
warned and reminded of the protocol. If this occurs multiple times, the member will be removed 
from the study and the mistakes reported to the IRB. Changes to protocol will not be 
implemented until approved by IRB.  
STUDY RISKS & BENEFITS 
Potential Risks to Study Participants & Risk Mitigation  
1. Potential Risk: Loss of confidentiality 
• Risk Mitigation: All reasonable barriers will be in place to protect against the 
potential loss of confidentiality: 
i. Data will be de-identified and data collection tools used to collect 
participants data will use unique subject ID numbers for identification 
ii. Only generic demographic variables (e.g., age, sex, race) needed to 
evaluate participant characteristics will be captured in data collection 
iii. Study materials and data collection tools will be kept in secure, locked 
areas only accessible to research team 
iv. Electronic spreadsheets will only be accessible to assigned authorized 
personnel and will be password protected 
v. Imaging (e.g., CT scan) will only be accessible by PI and clinical staff, 
and will be de-identified and labeled with subject ID numbers before 

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volumetric assessments are completed 
vi. Study records will be continually monitored by study coordinators to 
ensure all data is de-identified. Any oversights will be corrected and 
research team members will be notified. 
2. Potential Risk: Harm from radiation exposure during weight-bearing CT scan 
• Risk Mitigation: All reasonable limitations and protections against potential 
adverse health effects that may be associated with radiation exposure will be in 
place: 
i. Patients that are not able to complete the WBCT necessary for volumetric 
assessments will be excluded 
ii. During the consent process, the research team and the participant will 
discuss and assess the participant’s exposure history and determine if the 
potential risk is acceptable for that participant. The participant will be 
given the opportunity to decline to participate in the study and not undergo 
the WBCT without any loss of benefits to which the participant was 
otherwise entitled. 
3. Potential Risk: Surgery and surgical device implantation risks including infection and 
foreign body reactions or sensitivities. Other specific adverse effects noted for the study 
devices include: osteomyelitis surrounding the TightRope, failure of the implant resulting 
in re-diastasis, and painful aseptic osteolysis related to the wear of the FiberWire (not 
noted for XP). The InternalBrace does not have any known increased risk beyond 
potential material sensitivity. 
• Risk Mitigation: All reasonable limitations and protections against potential 

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adverse health effects that may be associated with surgery and device 
implantation will be in place: 
i. The study doctor will complete standard of care evaluations to determine 
whether the patient is a good candidate for either of the TightRope fixation 
procedures. 
ii. During the consent process, the research team and the participant will 
discuss and assess the participant’s history and determine if the potential 
risk of device or surgical related risks are acceptable for that participant. 
The participant will be given the opportunity to decline to participate in 
the study and not undergo the TightRope procedure without any loss of 
benefits to which the participant was otherwise entitled. 
iii. Standard of care procedures will be followed during the procedure to 
minimize the risk of infection and device failure.  
iv. Post-operative directives and follow-ups will follow standard of care to 
minimize device failure, and any adverse effect throughout study timeline 
will be reported as required and outlined above.  
4. Potential Risk: Psychosocial stress or discomfort as a result of filling out the 
questionnaires 
• Risk Mitigation: All reasonable procedures will be in place to protect against 
psychosocial stress or discomfort related to questionnaires, and patients will be 
informed that participation is voluntary and that they may cease participation at 
any time.  
Potential Benefits to Participation 

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There are no known benefits to the participants for participating in the study. However, it 
is possible that their involvement may advance knowledge and evidence regarding best practices 
for caring for ankle injuries that disrupt the syndesmosis. 
STATISTICAL ANALYSIS PLAN 
 
Significance will be set a priori at P = 0.05. All statistical analyses will be conducted 
using IBM SPSS Statistics, Version 28 (IBM Corporation, Armonk, NY). Descriptive analysis 
will be performed to describe participant characteristics and independent t-tests will be used to 
determine differences in pre-operative characteristics and outcomes between groups. In order to 
compare the 3D syndesmotic volume between groups, the volume ratio will first be calculated 
for each patient by dividing the syndesmotic volume of the contralateral uninjured ankle by the 
syndesmotic volume of the operative ankle.11 Separate t-tests will then be performed to 
determine whether there are differences between the volumetric ratios, FAOS scores, and SF-36 
scores between groups at each collection time point. Pearson-product moment correlations will 
be conducted to explore relationships between the volumetric ratios and each PRO (FAOS and 
SF-36) at both 6-weeks and 3-months. Pearson correlation coefficients (r) will be interpreted as 
(negligible < 0.3, low = 0.3-0.49, moderate = 0.5-0.69, high = 0.7-0.89, very high = 0.9-1.0).  
 
 

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