External Fixation Versus Splinting of Acute Calcaneus Fractures Prior to Definitive Surgery
Phase: NA
Conditions: Calcaneus Fracture
Sponsor: University of California, Davis

External Fixation Versus Splinting of Acute Calcaneus Fractures 
 
NCT04063657 
 
May 2, 2019 

PROTOCOL TITLE: Staged External Fixation of Acute Calcaneal Fractures 
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HRP-503-PTOTOCOL TEMPLATE-General 
 
 
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INSTRUCTIONS: use in conjunction with the online Initial 
Review Application form when no sponsor authored 
protocol is available. 
1) 
Protocol Title 
Title:  Staged External Fixation of Acute Calcaneal Fractures 
Protocol Version Date: 05/02/2019 
2) 
Objectives 
 
Aim:    
o Determine if external fixation decreases soft tissue complications compared 
to splinting. 
o Determine if external fixation decreases time to definitive surgical 
stabilization and improves final fixation compared to splinting. 
o Determine if external fixation improves functional outcomes as evaluated by 
validated funcational scoring systems.  
Hypothesis:  
o External fixation improves definitive fixation and functional outcomes of 
acute calcaneal fractures with decreased complication rates compared to 
splinting 
 
 
3) 
Background 
 
Acute displaced calcaneal fractures are a regularly encountered orthopedic injury that can 
be complex to treat.  Operative treatment of these fractures has been shown to have 
improved functional outcome scores compared to patients treated non-operatively.1-3  
Operative treatment aims to reduce the articular surface and restore radiographic 
parameters such as Bohler’s angle, both of which have been correlated with improved 
long term morbidity.4-5   
Within operative management options the definitive operative choice to minimize soft 
tissue and post-operative complications remains controversial.  Minimally invasive and 
percutaneous fixation techniques of complex calcaneus fractures has been shown to 
decrease soft tissue complications compared to open reduction internal fixation (ORIF) 
techniques.6-7 However, there is concern about the use of percutaneous techniques 
leading to a loss of reduction and important radiographic parameters.6  Additionally, 
direct visualization that is offered in an open technique is often preferable.  

PROTOCOL TITLE: Staged External Fixation of Acute Calcaneal Fractures 
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Clinicians favoring an open technique have sought ways to minimize soft tissue 
complications by using a temporary external fixator as similar to the often utilized staged 
management of tibial plateau and tibial plafond fractures.8-10  This delay is necessary for 
soft tissue swelling to subside prior to surgery with the external fixator allowing for 
prevention of early clot and fibrinous material between malaligned fracture fragments 
that may impede definitive reduction in the operating room.  Additionally, early 
temporary fixation will restore native soft tissue biology and calcaneal morphology 
allowing for optimal healing conditions prior to definitive fixation.   
Given these benefits, external fixators have been studied to treat acute calcaneus fractures 
definitively, in a brief-(days) or prolonged- (months) staged approach.11-15  To date there 
has only been three case series describing a brief-staged technique with use of an external 
fixator for treatment of complex calcaneal fractures.16-18  Our study will provide the first 
prospective-randomized controlled trail of this potentially practice changing protocol. 
The purpose of this study is to compare the efficacy of temporary external fixation vs. 
splinting for the treatment of acute calcaneal fractures prior to definitive surgical fixation. 
Reference: 
1. De boer AS, Van lieshout EM, Den hartog D, Weerts B, Verhofstad MH, Schepers 
T. Functional outcome and patient satisfaction after displaced intra-articular 
calcaneal fractures: a comparison among open, percutaneous, and nonoperative 
treatment. J Foot Ankle Surg. 2015;54(3):298-305. 
2.  Melcher G, Bereiter H, Leutenegger A, et al. Results of operative treatment for 
intra-articular fractures of the calcaneus. J Trauma 1991; 31:234–8.   
3.  Basile A. Operative versus nonoperative treatment of displaced intra- articular 
calcaneal fractures in elderly patients. J Foot Ankle Surg 2010;49:25–32.   
4. Loucks C, Buckley R. Bohler's angle: correlation with outcome in displaced intra-
articular calcaneal fractures. J Orthop Trauma. 1999;13(8):554-8. 
5. Waseem M. The use of subtalar arthroscopy in open reduction and internal fixation 
of intra-articular calcaneal fractures. Injury. 2003;34(6):475. 
6. DeWall M, Henderson CE, McKinley TO, Phelps T, Dolan L, Marsh JL. 
Percutaneous reduction and fixation of displaced intra-articular calcaneus fractures. J 
Orthop Trauma 2010;24(8):466-72.  
7. Jin C, Weng D, Yang W, He W, Liang W, Qian Y. Minimally invasive percutaneous 
osteosynthesis versus ORIF for Sanders type II and III calcaneal fractures: a 
prospective, randomized intervention trial. J Orthop Surg Res. 2017;12(1):10. 
8. Sirkin M, Sanders R, DiPasquale T, Herscovici D, Jr. A staged protocol for soft 
tissue management in the treatment of complex pilon fractures. J Orthop Trauma 
2004;18(8 Suppl):S32-8.  
9. Thordarson DB. Complications after treatment of tibial pilon fractures: prevention 
and management strategies. J Am Acad Orthop Surg 2000;8(4):253-65.  

PROTOCOL TITLE: Staged External Fixation of Acute Calcaneal Fractures 
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10. Egol KA, Tejwani NC, Capla EL, Wolinsky PL, Koval KJ. Staged management of 
high-energy proximal tibia fractures (OTA types 41): the results of a prospective, 
standardized protocol. J Orthop Trauma 2005;19(7):448-55; discussion 56.  
11. Fu TH, Liu HC, Su YS, Wang CJ. Treatment of displaced intra-articular calcaneal 
fractures with combined transarticular external fixation and minimal internal 
fixation. Foot Ankle Int 2013;34(1):91-8. [15] Begue T, Mebtouche N, Auregan 
JC, Saintyves G, Levante S, Cottin P, et al.  
12. External fixation of the thalamic portion of a fractured calcaneus: a new surgical 
technique. Orthop Traumatol Surg Res 2014;100(4):429-32. [16] Magnan B, 
Bortolazzi R, Marangon A, Marino M, Dall’Oca C, Bartolozzi P.  
13. External fixation for displaced intra-articular fractures of the calcaneum. J Bone 
Joint Surg Br 2006;88(11):1474-9. [17] Besch L, Waldschmidt JS, Daniels-
Wredenhagen M, Varoga D, Mueller M,  
14. Hilgert RE, et al. The treatment of intra-articular calcaneus fractures with severe soft 
tissue damage with a hinged external fixator or internal stabilization: long-term 
results. J Foot Ankle Surg 2010;49(1):8-15.  
15. Kissel CG, Husain ZS, Cottom JM, Scott RT, Vest J. Early clinical and radio- 
graphic outcomes after treatment of displaced intra-articular calcaneal fractures 
using delta-frame external fixator construct. J Foot Ankle Surg 2011;50(2):135-40.  
16. Githens M, Shatsky J, Agel J, Bransford RJ, Benirschke SK. Medial external 
fixation for staged treatment of closed calcaneus fractures: Surgical technique and 
case series. J Orthop Surg (Hong Kong). 2017;25(3):2309499017727915. 
17. Farrell BM, Lin CA, Moon CN. Temporising external fixation of calcaneus fractures 
prior to definitive plate fixation: a case series. Injury. 2015;46 Suppl 3:S19-22. 
18. Baumgaertel FR, Gotzen L. Two-stage operative treatment of comminuted os calcis 
fractures. Primary indirect reduction with medial external fixation and delayed 
lateral plate fixation. Clin Orthop Relat Res. 1993;(290):132-41. 
 
 
4) 
Inclusion and Exclusion Criteria 
 
Inclusion Criteria 
Exclusion Criteria 
• 
Voluntary consent 
• 
Age 18 to 69 
• 
Clinical and/or advanced imaging 
confirming an acute calcaneal fracture that 
has occurred within 2 days of which, 
eventually definitive surgery is 
recommended/accepted. 
 
 
• 
unable to consent 
• 
age <18  
• 
Prior surgery of the affected extremity 
• 
Prisoners 
• 
Pregnant women 
• 
Inflammatory arthritis  
• 
Non-english speaking spatients  
 

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5) 
Study Timelines 
 
• Study will begin after IRB approval  
• Patient recruitment will take place over two years, however this may be 
lonher depening on the number of patients who require definitive surgery  
• The duration of the subject’s participation in the study will conclude at 
two year postoperatively 
• The primarly analysis will be complete within 3 years of the study start 
time 
 
6) 
Study Endpoints and Procedures involved 
 
I. 
Design  
o Subjects will be recruited from the UC Davis Medical Center. Adults 
diagnosed with an acute (<1-2 days from injury) calcaneal fracture 
recommended for operative treatment will be offered enrollment into 
the study. 
o A total of 100 patients will be enrolled in the study. The sample size 
can be calculated at 35 per treatment groups after considering multiple 
comparisons and using an 80% power and an α = 0.05. This would 
require a minimum of 70 patients for the study; however, factoring in a 
30% dropout rate, a minimum of 100 patients will be enrolled into the 
study with a minimum of 50 patients per group. 
II. 
Methods 
o Patients will be randomized to one of two treatment groups: 
temporary external fixation or temporary splinting. Both temporary 
treatments are those routinely used/available at the UCD health 
system. Subject are to wear the temporary treatment method until 
definitive surgery. 
o Safety endpoints occur at conclusion of the definitive fixation of their 
calcaneal fracture. 

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o All subjects will receive standard perioperative and operative treatment of 
their injury.  Patients will receive standard clinical follow up for which their 
healing and functional status will be continually evaluated.    
o Follow up after surgery will be at 6 time points: 2 weeks, 6 weeks, 12 weeks, 
6 months, 1 year, 2 years 
o The research related activities are randomization, using SOS surveys at 
specified time points, and collecting/reporting data regarding the outcomes 
from routine visits and survey responses.  
  
III. 
Outcomes 
Primary outcome   
1. Time to definitive surgery 
2. Soft tissue complications (at routine follow ups which are 2, 6, & 12 weeks, 
and 6, 12, & 24 months after surgery)  
Secondary outcomes  
1. Union rate via standard weight bearing plain radiographs ( harris axial/lateral 
views) at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery. We 
will also obtain a 1X CT scan of the injured foot at 1 year after surgery to 
monitor for arthritic progression. 
2. Radiographic parameters(Bohler’s angle, clancaneal height/width/length, and 
angle of Gissan) 
3. Other complications 
4. Clinical outcomes will be evaluated to monitor patients’ activity levels, pain, 
and functional status. This will be done primarly using the web-
based Surgical Outcome SystemTM  (SOS)  
• 
The SOS is currently a UCD IRB approved study (IRB # 1192222). It is 
a large international web-based registry that permits collection of baseline 
characteristics of patients undergoing orthopedic 
procedures. The data is collected using direct entry into a web-based collection 
system called the Surgical Outcome System (SOS).  By completing these 
surveys, the investigator surgeon has the opportunity to monitor the 
subjects progress after treatment, even when they are not scheduled to see the 
provider. The investigator surgeon will also be able compare the outcomes to the 
average de-identified global data.  
• 
In order to utilize the web-based surveys, we would 
invite patients to dual enroll and consent into SOS. If, the subject forgoes SOS 
participation, the surveys may be filled out manually and this data will not 
be part of SOS.   
• 
Subjects fill out surveys  before visits at 7 total time points: 
preoperatively, & postoperatively at 2, 6, and 12 weeks and 6 months, 1 and 2 

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years. The surveys may include the Visual Analogue pain score(VAS), Patient-
reported outcomes measurement information system 10 short form (PROMIS 
10), or Veterans RAND 12 item Health survey (VR-12), Foot function index 
questionnaire (FFI-R) or Foot and Ankle Ability measure activities of daily 
living (FAAM ADL), and FAAM sport 
IV. 
Analysis: The data will be analyzed for differences between splinting 
and external fixator treatement groups. Data will be stratified and 
analyzed for further differences in outcomes based on other factors (ie: 
demographics, comorbidities..) 
• To assess significance the alpha level will be set at <0.05. 
• Continuous data will be reported as means, standard 
deviation(SD), range, with 95% confidence intervals 
• Categorical data will be reported as frequencies or percentages 
with 95% confidence intervals  
 
7) 
Data and/or Specimen Management and Confidentiality 
I understand that the UC Davis Health Electronic Health Record 
(EMR/EPIC) also contains the clinical data for Marshall Medical 
Center (MMC). I understand that MMC patient data cannot be accessed 
for research purposes and that I must take the necessary steps to ensure 
that MMC data is not accessed, used, or disclosed for UC Davis Health 
research purposes. 
 
Since this is a prospective study, the PI/research team are part of the data 
collection process. Thus, the data will be identifiable at first to the research team. 
However, all efforts will be made to de-identify the data. A coding system will be 
used to assigned a unique code to each subject. Only authorized research staff 
members will have access to data.   
 
All identifiable electronic data will be maintained on an encrypted device 
requiring password for access. Passwords will not be shared and will be protected 
from access.   
 
If protected health information or personal information from the medical records 
will be stored on an encrypted device, investigators will follow 
applicable university policies (UC Davis Hospital Policy 1313, UCDHS P&P 
2300-2499, and UC Business and Finance Bulletin on Information Security (IS-
3).    
 
All paper records will be stored in a locked room/file-cabinet with access limited 
to only individuals who have a right and need for access.   
 

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8) 
Data and/or Specimen Banking 
If the patient also provides voluntary consent to enter the SOS web-based registry, 
the subject will be dual consented and also enrolled into the SOS. The data will 
enter the main SOS global registry(de-identified).   
 
9) 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
This is a minimal risk study. There are no anticipated risks specific to study 
participation. There are no experimental procedures and participation in this study 
is not anticipated to affect the medical treatment of enrolled subjects.  
Subjects will be randomized into two temporary treatments are likely to benefit 
from either arm of the study.  
Procedures performed are currently standard of clinical practice for management 
calcaneal fractures.  
In order to protect the rights and welfare of the subjects, an initial site set-up visit will be 
performed to ensure proper documentation. Further monitoring (including the close 
out visit) will take place as needed by our internal Research staff. The PI reviews and 
track all  complications as standard care. 
 
 
10) Withdrawal of Subjects 
• 
Subjects can voluntarly withdrawl at anytime   
• 
Otherwise, the subjects are withdrawn if:  
o 
They have inadequate follow up without communicating with research 
staff.   
o 
Their health changes, and staying in the study is no longer in his or her 
best interest  
o 
They do not follow the study rules or no longer meet requirments to be in 
the study  
o 
The  researchers terminate the study.   
11) Risks to Subjects 
 
There are no physical risks in this study.  
 
There is the risk of randomization in this study.  
 
There is a privacy risk, since we will record data which poses the risk of loss of 
confidentiality. The risk will be minimized through the processes described 
above. This study will abide by all applicable law, regulations, and standard 

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operating governing the protection of human subjects, student information and 
protected health information.  
 
 
 
12) Potential Benefits to Subjects 
These subjects are not likely to received any benefit from the proposed 
research, but others may benefit from the knowledge obtained  
 
 
13) Multi-Site Research: Not applicable 
14) Community-Based Participatory Research: Not applicable 
. 
15) Sharing of Results with Subjects 
 
Subjects will be aware of the survey scores as they are self-reported. Subjects will 
be aware of which treatment option they receive as they are visible. The results of 
this study will not be shared with other subjects or others.   
 
 
16) Prior Approvals: IRB approval 
17) Provisions to Protect the Privacy Interests of Subjects 
 
The subjects’ privacy interests will be protected, as information will only be made 
available to those directly involved in the research study. The information will be 
stored in a password-protected spreadsheet which will have a assigned a code to 
protect patient confidentiality. The code will be kept separate from the data. At 
the completion of the data analysis, the code key will be destroyed.   
The subjects will feel at ease as researchers will treat them with respect and 
address any of their questions/concern  

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18) Compensation for Research-Related Injury: Not applicable as study 
is minimal risk   
 
19) Economic Burden to Subjects: No different from routine care, and 
thus billed to insurance.  
 
 
20) Drugs or Devices:  
 
The devices used in this study is FDA approved and thus not investigational. 
The device will be used as intended by FDA.  
 
 
21) Review Requirements 
        Are there any contractual obligations or other considerations that 
require IRB review of this research, or review at intervals other 
than those required by the Common Rule or FDA? If yes, check 
box: NO