Evaluation of Safety and Performance Outcomes of the Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
Phase: NA
Conditions: Ankle Fractures, Bimalleolar Fractures, Syndesmotic Injuries, Bimalleolar Equivalent Fracture, Maisonneuve Fracture, Trimalleolar Fractures, Ankle Dislocation
Sponsor: Maimonides Medical Center

Maimonides Medical Center Protocol May 9, 2022 
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TITLE 
Evaluation of Safety and Performance Outcomes of the Fibulink Syndesmosis 
Repair System with Early Full-Weight Bearing 
Unique Protocol ID: 2022-08-15 
Document Date:  May 9, 2022 

 
 
 
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 Complete Sections 1.0 – 12.0 to create the Protocol for Submission. 
 
SECTION 1.0: Protocol Background 
1.1 Full Protocol Title 
Evaluation of Safety and Performance Outcomes of the Fibulink Syndesmosis Repair System 
with Early Full-Weight Bearing Protocol 
1.2 Version and Date 
5     /9     /22  
1.3  Principal Investigator 
Dr. Amr Abdelgawad 
1.4 Institution and Address 
Maimonides Medical Center, 4802 10th Ave, Brooklyn, NY 11219 
1.5 Sub-Investigators (if applicable) 
Dr. Aaron Lam, Dr. Mitchell Ng, Dr. Adam Gordon, Dr. Ahmed M. Thabet 
1.6 Multi-center Institutions and Address (if applicable) 
Texas Tech University Health Sciences Center, El Paso, Texas 
 
SECTION 2.0: Statement of Compliance 
2.1 Include a statement that the study will be conducted in 
accordance with specific provisions of the associated IRB/IECs, 
and in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki, and that are consistent 
with Good Clinical Practice (GCP) and the applicable national 
and regional regulatory requirement(s) 
The study will be conducted in accordance with specific provisions of the associated IRB/IECs, 
and in accordance with the ethical principles that have their origin in the Declaration of 
Helsinki, and that are consistent with Good Clinical Practice (GCP) and the applicable national 
and regional regulatory requirement(s). 
 
SECTION 3.0: Background Information and Scientific Rationale 
3.1 Identification and description of the study product and its 
intended purpose 
Fibulink Syndesmosis Repair System is a multi-component anchor system designed for the 
treatment of syndesmotic disruption in the setting of unstable ankle fractures. It composes of 
a suture bridge within a screw fixation system. Previous methods of fixation include trans-
osseous screw fixation and suture-button technique. However, limitations of screw fixation 
include delayed weight bearing, risk of screw breakage and need for subsequent screw 
removal.1 The use of suture button technique improved on the limitations of screw fixation by 
allowing earlier weight bearing and more physiological motion at the syndesmotic joint.2 
Despite the success, limitations of the suture button technique include the lack of tension 
control within the suture system3 and the need to make a separate medial incision. The 
Fibulink Syndesmosis Repair System combines the advantages of the previous two fixation 
techniques to allow for a more precise and anatomic syndesmotic fixation. 
3.2 Description of the intervention and/or procedures for which the 
study product is intended 
The study product is intended to adjunct open reduction and internal fixation of ankle 
fractures with concomitant disruption of the syndesmosis. 
3.3 Description of the populations and indications for which the 
study product is intended 
Adult patients (ages 22 yo and older     ) who sustained ankle fractures with disruption of the 
syndesmosis. This includes patients with syndesmotic sprain (without fractures) who 
demonstrates instability on stress radiographs, bimalleolar equivalent ankle fractures with 
syndesmotic disruption, bimalleolar ankle fractures with syndesmotic injuries, Maisonneuve 
fractures, trimalleolar ankle fractures without the need for posterior malleolus fixation and 
ankle fracture dislocations. 
3.4 A summary of relevant previous pre-clinical and clinical studies 
(as applicable) 
 The Fibulink Syndesmosis Repair System has been evaluated and compared to the Arthrex 
Syndesmosis TightRope in a biomechanical study.4 When assessing the total medial to lateral 
displacement at the syndesmosis during dynamic testing at 300,000 cycles, TightRope was 
found to have a statistically significant higher average displacement when compared to the 
Fibulink (2.07 mm v 0.61mm, P<0.001). During static load-to-failure testing, Fibulink system 

 
 
 
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was found to require a statistically significant higher average load at 2 mm displacement and 
ultimate load. In a 14 patient case series using the Fibulink system, short term outcome 
measures (AOFAS and VAS) were favorable with no reported complications.5 
3.5 A summary of potential risks and benefits (including steps that 
will be taken to control or mitigate risks) 
Benefits of the Fibulink system include the avoidance of a medial-sided incision which would 
eliminate the risk of injury to the nearby neurovascular structures (ie: saphenous vein) and 
possible soft tissue entrapment. In addition, the Fibulink system is designed to allow for 
setting and adjusting the desired tension at the syndesmosis. This allows for better control in 
optimizing the final syndesmotic gap. Risks of the Fibulink system includes the loss of 
reduction and the maintenance of the syndesmosis reduction and difficult removal, planned 
or unplanned. To control the risks, we will have set time points where we evaluate the 
syndesmosis via standard radiographs. If there is a loss of reduction or maintenance of the 
reduction, the study will end for the affected patient. Revision surgery will be performed. 
3.6 References to literature and data that are relevant to the study 
and that provide background for the study 
Please see section 12.0 
 
SECTION 4.0: Study Objectives/Design 
4.1 Describe the purpose of the study 
The purpose of the study is to evaluate the ability of the Fibulink Syndesmosis Repair System 
to maintain reduction of the ankle syndesmosis. Appropriate reduction of the syndesmosis is 
critical due the changes in tibiotalar contact pressure observed in cadaveric studies.6,7 
Malreduction and instability of the distal tibiotalar joint can lead to chronic instability, 
increased articular damage and ultimately degenerative arthritis.7,8 Medial to lateral 
translation of distal tibia and fibula of 2 mm or more has been considered pathologic.9 Earlier 
biomechanical study demonstrated the Fibulink system is superior in maintaining 
displacement of less than 2 mm.4 Given the improved strength, we also look to evaluate the 
outcomes of initiating full weight bearing (100%) with CAM boot at 4 weeks postoperatively. 
One of the big limitations for trans-osseous screw fixation is delayed weight bearing due to 
risk of screw breakage.1 Suture button technique allowed for early weight bearing with 
average of 6 weeks postoperatively using TightRope.2,10–12By initiating full weight bearing 
(100%) with CAM boot at 4 weeks postoperatively, this would be a significant improvement in 
current clinical practice. 
4.2 Primary Objective  
The primary objective is to evaluate the reduction and maintenance of the reduction of ankle 
syndesmosis in 6 months after initiating full weight bearing (100%) at 4 weeks or 6 weeks           
postoperatively. This will be determined based on comparing the tibiofibular overlap, 
tibiofibular clear space and medial clear space preop values. 
4.3 Secondary Objective 
The secondary objectives include: 1) reduction and maintenance of the reduction of the ankle 
syndesmosis at 2 weeks, 4-6 weeks, 8-10 weeks and 3 months based on the      tibiofibular 
overlap, tibiofibular clear space and medial clear space preop values. 2) rate of unplanned 
re-operation or late-stage revision, 3) operative statistics (i.e. OR time, surgical 
approach/procedure, type of additional fixation), 4) safety data such as intra- and post- 
operative complication rates 
4.4 Exploratory Objective 
Not applicable. 
4.5 Rationale for selection of endpoints 
The rationale of the endpoints selected is to evaluate the short-term clinical outcomes (6 
months) using the Fibulink Syndesmosis Repair System for fixation of a syndesmotic injury. If 
reduction is maintained at six months, no further displacement should be expected as full 
healing of the native ligaments is achieved. 
4.6 Describe the hypothesis (i.e. non-inferiority or superiority) 
Reparation of the syndesmosis with the Fibulink Syndesmosis Repair System will maintain the 
reduction of the syndesmosis at 6 months follow-up. Initiating full weight bearing (100%) in 
CAM boot at 4 weeks postoperatively is safe (when compared to the standard 6 weeks 
postoperatively) given that early biomechanical studies have demonstrated superior dynamic 
and load-to-failure testing when compared to the TightRope system.4  
4.7 Describe the design of the control group used (i.e. type, 
prospective, historic), if any  
Not applicable. 
4.8 Describe the expected duration of subject participation, 
targeted enrollment duration along with sequence and duration 
of all study periods, including follow up 
The enrollment duration is planned for 2      year. Every patient that is enrolled will have a 
minimum of 6 months follow-up. The research coordinators will follow-up with study patients 
to ensure compliance with study and prevent drop out.  

 
 
 
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4.9 Describe measures to be taken to minimize or avoid bias on the 
part of subjects, investigators, and analysts including 
randomization, if applicable.  Include process of the 
randomization procedures 
All potential participants will be informed of the study purpose. All treatment options for 
ankle fractures with syndesmotic injuries will be explained. Risks and benefits of each option 
will be discussed in full detail. Informed consent will be obtained before enrollment of 
participants in the study.  
A separate informed consent for surgery will be obtained. 
In addition, clear measurement criteria will be determined before the initiation of the study. 
Patients will be randomized into one of two groups: group 1) full weight bearing (100%) 
initiated at 4 weeks postoperatively and group 2) full weight bearing (100%) initiated at 6 
weeks postoperatively. The rest of the study, including operative technique and 
postoperative protocol, will remain the same for both study groups.       
Computer based systems will be utilized to perform statistical analysis.   
4.10 Describe “stopping rules” or “discontinuation criteria” for 
individual subjects, parts of study, and entire study 
For individual subjects: if revision surgery is needed. Indications for revision surgery include 
intra-operative Fibulink breakage, system malfunction, inability to correctly tension the 
suture system and postoperative complications such as screw/suture breakage, subsidence, 
and infection. 
For the study: if more than 4 patients develop implant-related complication. Implant-related 
complications include intra-operative Fibulink breakage, system malfunction, inability to 
correctly tension the suture system and postoperative complications such as screw/suture 
breakage, subsidence, and infection. 
 
SECTION 5.0: Study Population 
Describe the population to be studied 
5.1 As appropriate, include background discussion/details on 
prevalence, for example: sex/race specific prevalence 
considerations, diagnosis, treatment patterns, and patients 
currently undergoing procedure regardless of study 
participation 
The study will be performed at two Level 1 trauma centers, in urban settings with a diverse 
patient population from age, sex and ethnicity. All patients with ankle injuries/fractures 
routinely received radiographs of the ankle to assess the extent of the fracture pattern with 
manual or gravity stress tests if needed. Routine surgical fixation of unstable ankle fractures 
with or without syndesmotic injuries including distal fibular fixation, medial malleolus fixation 
(if necessary) and syndesmotic fixation (using trans-osseous screw fixation or suture button).  
5.2 List inclusion and exclusion criteria. Include characteristics of 
subjects by age, sex, and condition. 
Inclusion criteria: 1) age > 22      yo, 2) ankle fracture with syndesmotic disruption as 
assessed with intra-operative cotton test. This includes the following injuries: 
- 
Syndesmotic sprain (without fractures) 
- 
Bimalleolar equivalent ankle fractures 
- 
Bimalleolar ankle fractures  
- 
Maisonneuve fractures 
- 
Trimalleolar ankle fractures without the need for posterior malleolus fixation 
- 
Ankle fracture dislocations 
 
Exclusion criteria: 1) previous ankle surgery, 2) active local infection about the ankle, 3) 
chronic ankle deformity secondary to trauma or congenital, 4) ligamentous laxity, 5) 
pathologic fractures, 6) peripheral vascular disease, 7) peripheral neuropathy, 8) diabetes 
neuropathy and charcot, 9) open fractures, 10) poly trauma, 11) inability to provide informed 
consent, 12) symptomatic ankle osteoarthritis, 12) retained hardware, 13) pregnant, 14) 
metabolic bone disease, 15) history of chronic steroid use, 16) mal-reduced ankle fractures 
(this will be determined through the parameters established in section 6.3) 
5.3 Describe withdrawal criteria and procedure(s), and procedures 
for replacement of subjects 
Participants are allowed to withdraw from the study at any time point. Patients will notify the 
investigators their wish to withdraw from the study. Should the participant request for 
removal all data collected, it will be honored. New participants will be recruited until the 
aimed number of participants at each site is achieved. 
5.4 Describe the number of investigational sites and number of 
subjects.  Include the minimum and maximum number of 
subjects to be included from each center in a multi-center study 
Number of site: 2 
Number of subjects: 56      (28      subjects in each group     ) 
 
SECTION 6.0: Study Procedures and Methodology 

 
 
 
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6.1 List key materials/devices required to execute the study (i.e. 
device, fixation, grafting material, sutures, neuromonitoring) 
Syndesmosis injury - Fibulink Syndesmotic Repair System 
Medial malleolus fracture – ORIF with screws 
Lateral malleolus fractures – ORIF with plate and screws   
6.2 Describe the study/surgical procedure and approach 
All ankle fractures will be evaluated by the orthopedic team. Standard radiographs including 
AP, lateral and mortise view of the ankle will be obtained. Manual or gravity stress view will 
be performed if needed. Treatment options including nonoperative and operative 
management will be discussed with the patient including the risks and benefits. An informed 
decision will be made. Two separate informed consent will be obtained. The first will be an 
informed consent for the surgery, detailing the planned surgical procedure. The second will 
be an informed consent for the enrollment of the study, detailing the purpose of the study 
and the use of the Fibulink Syndesmotic Repair System in any cases of syndesmotic injury.  
 
Should the patient elects to proceed with surgery, the patient will be informed that fixation of 
the fractures will be performed first. Direct lateral approach to the distal fibular will be used 
for fixation of the lateral malleolus. If necessary, direct medial approach will be used for 
fixation of the medial malleolus. Once the fractures have been fixed, the syndesmosis will be 
stressed intraoperatively under live fluoroscopy. Based on the parameters described in 6.3, a 
decision will be made whether fixation of the syndesmosis is required if instability is noted. If 
fixation of the syndesmosis is required, it will be performed through the direct lateral 
approach.  
 
The research coordinator will be informed of all patients that had the syndesmosis fixed with 
the Fibulink System. Patients will then be followed at the following time points: 2 weeks, 4-6 
weeks, 8-10 weeks, 3 months and 6 months. During each follow-up time points, the 
tibiofibular overlap, tibiofibular clear space and medial clear space will be measured and 
recorded. The postoperative protocol will be as follow: Immediately post-op, patient will be 
placed in a short leg cast. At 2 weeks postop, the short leg cast will be removed. Suture 
removal will be performed. Patient will be placed in a CAM boot and instructed to perform 
early active ankle range-of-motion. Depending on the study group, at 4 weeks or 6 weeks 
postop, full weight bearing (100%)      in the CAM boot will be allowed. Physical therapy will 
begin. At 8-10 weeks postop, full weight bearing (100%)      without CAM boot will begin. 
Patients will continue to follow-up at 3 months and 6 months. 
 
The research coordinator will ensure proper follow-up and will be responsible for data 
collection and input. After achieving the planned number of participants, the results of the 
two study sites will be gathered. Appropriate statistical analysis will be performed, and the 
results will be presented in a full manuscript format. 
6.3 Describe all clinical observations/evaluations, medical history 
assessments, radiographic assessments, patient reported 
outcomes as applicable 
Preop: XRs (AP, lateral, mortise) with manual or gravity stress view if needed 
Intraoperative: Live fluoroscopy with Cotton test13 
Postop: XRs (AP, lateral, mortise) 
 
Radiographic assessments: tibiofibular overlap, tibiofibular clear space, medial clear space 
widening under normal mortise and manual stress 
 
Normal values: 
1) 
Tibiofibular overlap: > 6 mm on AP, > 1 mm on Mortise14,15 
2) 
Tibiofibular clear space: < 6 mm on AP and Mortise14,15 
3) 
Medial clear space: < 5 mm on Mortise10 
 
Using the above 3 values (tibiofibular overlap, tibiofibular clear space and medial clear 
space), radiographic assessments of the syndesmosis at preop and the pre-defined time 
points (at 2 weeks, 4-6 weeks, 8-10 weeks, 3 months and 6 months) will be recorded and 
compared. At the end of the study period, success of maintaining syndesmotic reduction will 
be based on comparing the tibiofibular overlap, tibiofibular clear space and medial clear 
space preop versus at 6 months to the normal values. 
 
The ac     ceptable threshold for changes in width of the syndesmosis is up to 2 mm.16–18  
 
For each patient, the age, sex, laterality, type of ankle injury/fracture and co-morbidities 
including BMI, diabetic status, smoking status, alcohol status will be collected. 

 
 
 
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The total number and rate of unplanned re-operation or late-stage revision will be collected. 
The reasons will be documented. 
 
Operative statistics to be collected include the total OR time, the surgical 
approach/procedure, the need for additional fixation. 
 
Safety data to be collected include intraoperative complications such as Fibulink breakage, 
system malfunction, inability to correctly tension the suture system and postoperative 
complications such as screw/suture breakage, subsidence, and infection. 
 
Pain will be measured (pre-operatively and at last follow-up). This will be measured 
through the visual analog scale (VAS) 
6.4 Attach Study Calendar to capture section timepoints/visits 
See example 
IIS Study Calendar* 
Check box to indicate Study Calendar is attached: 
☒ 
6.5 Document criteria for radiographic assessment (i.e. fusion 
criteria, subsidence) and who will conduct the assessment (i.e. 
radiologist, 2 independent surgeons) 
Reduction of syndesmosis criteria: 
Assessment will be conducted by senior author using standard XRs (AP, lateral, mortise) while 
evaluating the tibiofibular overlap, tibiofibular clear space, medial clear space as described in 
6.3. This would be performed at the following time points: preop, 2 weeks, 4-6 weeks, 8-10 
weeks, 3 months and 6 months. 
 
SECTION 7.0: Assessment of Safety 
Safety parameters should be clearly outlined in this section.  As appropriate for the study, state applicable definitions. 
7.1 Describe the management and reporting of device and 
procedure related Adverse Events (AEs) and safety data 
     The management and reporting of device and procedure related adverse events and safety 
data will be conducted by our department’s research fellow, Dr. Adam Gordon. Appropriate 
authorities will be notified if any adverse events occurred. 
 
SECTION 8.0: Methods of Quality Control 
8.1 A general outline of the methods of quality control of 
data should be outlined here  
The primary objective of the study is to evaluate the reduction and maintenance of the 
reduction of the ankle syndesmosis at 6 months. In addition, the quality and maintenance of 
the reduction at 2 weeks, 4-6 weeks, 8-10 weeks, and 3 months postop will be assessed as 
well. This will be determined through objective measurements described in other published 
papers via standard radiographs (AP, Lateral and Mortise) to measure syndesmotic reduction. 
These measurements include the tibiofibular clear space, tibiofibular overlap and medial clear 
space.10,15 
 
The review of the radiographs will be performed the same for each subject. Internal quality 
control audits will be performed after recruitment of cohorts of 5 patients to ensure the data 
is accurate and reliable.  
 
The senior authors (Dr. Amr Abdelgawad, Dr. Ahmen Thabet) and sub-investigator (Dr. Aaron 
Lam) will interpret and determine the reduction of the syndesmosis from the acquired 
radiographs. 
 
SECTION 9.0: Statistical Methodology 
Include a description of the analyses which will be performed including planned analyses when applicable (i.e. 12 months planned analysis), safety assessment, and the 
final analysis plan.  This may include, 
9.1 Provide a description of how the sample size for the study was 
determined.  If appropriate, show sample size derivations 
and/or statistical power estimates for each appropriate 
endpoint, and estimate the overall power for successfully 
meeting all endpoints.  This section may include a statement 
about the number of sites and/or the number of subjects at 
each site 
     Non-inferiority study 
 
If there is truly no difference between the standard and experimental treatment (90% in 
both groups), then 56 patients (28 per group) are required to be 80% sure that the upper 
limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence 
interval) will exclude a difference in favor of the standard group of more than 20%. 
 

 
 
 
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9.2 Expected drop-out rates 
25%. The research coordinators will follow-up with study patients to ensure compliance with 
study and prevent drop out.  
9.3 Provisions for planned analyses 
Calculate rate of unplanned re-operation and/or late-stage revisions, intra- and post-
operative complication rates 
Calculate operative stats including: mean OR time 
SECTION 10.0: Ethics/Protection of Human Subjects 
10.1 State the requirement to obtain IRB/IEC approval prior to 
execution of the protocol and IRB documentation required or 
provided rationale 
The study will be conducted in accordance with specific provisions of the associated IRB/IECs, 
and in accordance with the ethical principles that have their origin in the Declaration of 
Helsinki, and that are consistent with Good Clinical Practice (GCP) and the applicable national 
and regional regulatory requirement(s). Each site will obtain full approval by their own 
institutional research ethics boards prior to the initiation of the study. 
10.2 Describe the general requirements for obtaining informed 
consent, including providing subjects with new information as 
needed. 
Patients who meet the study’s inclusion criteria will be informed of the nature of the 
syndesmotic injury and the reasons for fixation. Patient will be informed of the types of 
fixation available including the standard trans-osseous screw, TightRope system and the 
Fibulink system. Patient will be informed of the planned study. They will be informed that 
there will be two study groups: full weight bearing (100%) at 4 weeks postop versus full 
weight bearing (100%) at 6 weeks postop. Assignments will be random. Patient will be 
informed of the standard weight bearing protocol (6 weeks postop) and reasons why earlier 
weight bearing is considered (4 weeks postop). With the patient’s approval, two separate 
informed consent will be signed: one for the actual planned surgery and one for the use of 
the Fibulink Syndesmotic Repair System.  
10.3 State that a copy of the protocol, informed consent forms, and 
other information to be completed by participants, such as 
survey instruments or questionnaires, and any proposed 
advertising or recruitment materials will be submitted to the 
IRB/IECs for written approval.  Additionally, the investigator 
must submit and obtain approval from the IRB/IEC for all 
subsequent amendments to the protocol, informed consent 
documents, and other study documentation referenced above. 
A copy of the protocol, informed consent forms, and other information to be completed by 
participants, such as survey instruments or questionnaires, and any proposed advertising or 
recruitment materials will be submitted to the IRB/IECs for written approval.   
10.4 Describe methods used to protect subject confidentiality 
All data will be collected and stored on site at Maimonides.  
 
PHI will not be disclosed to persons outside of the Medical Center. 
Identifiable information will be stored in a secure manner (password protected database) 
accessible only to research study investigators. 
Forms used for recording data for this study will not have any participant identifiers. 
The study team will use coded information which does not have any elements of PHI. 
No photocopies will be made of any patient chart, lab or other clinical information. 
All research files including the physical paper consents will be stored in a locker with the key 
kept by the research coordinator while they are unsupervised. 
We will keep electronic data stored in password protected files and will not email any 
information unless it can be encrypted. 
All PHI will be used only on site at MMC and will not be disclosed to any outside entity.  
All computers that will be used are password protected. 
 
SECTION 11.0: Data Handling and Record Keeping 
General procedures for data management should be included within the protocol. 
11.1 Describe data management procedures, where the data will be 
stored, from example, data collection (specify whether via 
electronic data capture or paper records), data handling, 
review, electronic data systems verification/validation, and 
data retention 
     All data will be collected and kept in a password protected file. All physical papers 
including consents will be stored in a locker with the key kept by the research coordinator. 
 
SECTION 12.0: Scientific References 

 
 
 
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List references as applicable to the background and scientific principles of the study 
Thornes B, Shannon F, Guiney AM, et al. Suture-button syndesmosis fixation: Accelerated rehabilitation and improved 
outcomes. Clinical Orthopaedics and Related Research. 2005;431:207–212. 
DeGroot H, Al-Omari AA, el Ghazaly SA. Outcomes of suture button repair of the distal tibiofibular syndesmosis. Foot and Ankle 
International. 2011;32:250–256. 
Morellato J, Louati H, Bodrogi A, et al. The Effect of Varying Tension of a Suture Button Construct in Fixation of the Tibiofibular 
Syndesmosis - Evaluation Using Stress Computed Tomography. Journal of Orthopaedic Trauma. 2017;31:103–110. 
 Dynamic and Load-to-Failure Testing of the DePuy Synthes FIBULINK TM Syndesmosis Repair System and Arthrex Syndesmosis 
TightRope ® XP Implant System Materials and Methods. 2020. 
Desai S. Syndesmosis Repair: 14 Patient Case Series. 
Ramsey PL, Hamilton W. Changes in tibiotalar area of contact caused by lateral talar shift. JBJS. 1976;58. 
Hunt KJ, Goeb Y, Behn AW, et al. Ankle Joint Contact Loads and Displacement with Progressive Syndesmotic Injury. Foot and 
Ankle International. 2015;36:1095–1103. 
Porter DA, Jaggers RR, Barnes AF, et al. Optimal management of ankle syndesmosis injuries. Open Access Journal of Sports 
Medicine. 2014;5:173. 
Hunt KJ. Syndesmosis injuries. Current Reviews in Musculoskeletal Medicine. 2013;6:304. 
Cottom JM, Hyer CF, Philbin TM, et al. Transosseous fixation of the distal tibiofibular syndesmosis: comparison of an 
interosseous suture and endobutton to traditional screw fixation in 50 cases. The Journal of foot and ankle surgery : official 
publication of the American College of Foot and Ankle Surgeons. 2009;48:620–630. 
Thornes B, McCartan D. Ankle syndesmosis injuries treated with the TightRopeTM suture-button kit. Techniques in Foot and 
Ankle Surgery. 2006;5:45–53. 
Latham AJ, Goodwin PC, Stirling B, et al. Ankle syndesmosis repair and rehabilitation in professional rugby league players: a case 
series report. BMJ Open Sport & Exercise Medicine. 2017;3:e000175. 
Cotton FJ. Dislocations and Joint-Fractures. Philadelphia: W. B. Saunders Company, 1910. 
Ebraheim NA, Lu J, Yang H, et al. Radiographic and CT evaluation of tibiofibular syndesmotic diastasis: a cadaver study. Foot & 
ankle international. 1997;18:693–698. 
Harper MC, Keller TS. A radiographic evaluation of the tibiofibular syndesmosis. Foot & ankle. 1989;10:156–160. 
Leeds HC, Ehrlich MG. Instability of the distal tibiofibular syndesmosis after bimalleolar and trimalleolar ankle fractures. JBJS. 
1984;66. 
Rigby RB, Cottom JM. Does the Arthrex TightRope® provide maintenance of the distal tibiofibular syndesmosis? A 2-year follow-
up of 64 TightRopes® in 37 patients. The Journal of foot and ankle surgery : official publication of the American College of Foot 
and Ankle Surgeons. 2013;52:563–567. 
Mukhopadhyay S, Metcalfe A, Guha AR, et al. Malreduction of syndesmosis--are we considering the anatomical variation? 
Injury. 2011;42:1073–1076. 
  
 
 
 

 
 
 
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APPENDIX 
Please mark X below 
(as appropriate) 
IIS Study Calendar – Trauma/CMF 
 
Procedure 
Visit 1 
Baseline 
Treatment 
Day 0 
Visit 2 
2 weeks 
Visit 3 
4 -6Weeks 
Visit 4 
8-10 Weeks 
 
Visit 5 
3 Months 
 
Visit 6 
 6 Months 
Informed Consent 
X 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
Physical Exam 
X 
 
 
 
 
 
 
Device / Procedure Related Adverse Events 
 
X 
 
 
 
 
 
Surgical Details 
 
X 
 
 
 
 
 
Patient Reported Forms (i.e.. VAS) 
 
X 
 
 
 
 
 
X-ray 
X 
 
X 
X 
X 
X 
X 
MRI 
 
 
 
 
 
 
 
CT 
 
 
 
 
 
 
 
Add additional info below 
 (if applicable) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
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