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Prospective Comparative study of extended lateral approach and sinus tarsi approach about Sanders type 2 calcaneus fracture

Status Approved

First Submitted Date

2017/12/18
Registered Date

2018/04/23
Last Updated Date

2018/03/22

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002820
Unique Protocol ID	YUH-13-0391-B6
Public/Brief Title	Prospective Comparative study of extended lateral approach and sinus tarsi approach about Sanders type 2 calcaneus fracture
Scientific Title	Prospective Comparative study of extended lateral approach and sinus tarsi approach about Sanders type 2 calcaneus fracture
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	YUH-13-0391-B6
Approval Date	2013-08-08
Institutional Review Board Name	Yeungnam University Hospital Institutional Review Board
Institutional Review Board Address	170 Hyeonchungro, Nam-gu, Daegu 42415, Korea
Institutional Review Board Telephone	053-620-4048
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Chul-Hyun Park
Title	Medical Doctor
Telephone	+82-53-620-3640
Affiliation	Yeongnam University Medical Center
Address	Department of Orthopedic Surgery, Yeungnam University Medical Center, Hyeonchunglo 170, Daegu, Republic of Korea, 701-703
Contact Person for Public Queries
Name	Jeong-jae Moon
Title	Medical Doctor
Telephone	+82-53-620-3640
Affiliation	Yeongnam University Medical Center
Address	Department of Orthopedic Surgery, Yeungnam University Medical Center, Hyeonchunglo 170, Daegu, Republic of Korea, 701-703
Contact Person for Updating Information
Name	Chul-Hyun Park
Title	Medical Doctor
Telephone	+82-53-620-3640
Affiliation	Yeongnam University Medical Center
Address	Department of Orthopedic Surgery, Yeungnam University Medical Center, Hyeonchunglo 170, Daegu, Republic of Korea, 701-703

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2013-08-08 Actual
Target Number of Participant	60
Primary Completion Date	2018-08-08 , Anticipated
Study Completion Date	2019-08-08 , Anticipated
Name of Study	Yeongnam University Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2013-08-08 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Yeongnam University Medical Center
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Yeongnam University Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The calcaneus is the largest bone in the foot and is an irregular rectangle with four articular surfaces. It supports the body weight firmly and absorbs and transmits the body weight. Calcaneal fractures occur at a frequency as high as 2% of the total fractures of the body. But, it is still a fracture with controversy over standard treatment methods. Calcaneal fractures can be classified as intra-articular fractures and extra-articular fractures, with intra-articular fractures accounting for 75%. In the treatment of intra-articular fractures, it is difficult to accurately reduce the joint surface, resulting in complications such as traumatic arthritis.The calcaneal fracture is a common comminuted fracture and the approach is important because it is difficult to reduce and fix the fracture fragments during surgical treatment. First, we will explain the extended lateral approach. Starting at the posterior of the fibula, An L-shaped incision will be made to expose the lateral wall of the calcaneus. Effort will be made a full thickness skin flap including sural nerve. Following exposure of the lateral wall of the calcaneus, subtalar and calcaneocuboid joints, this allows accurate reduction of the articular surface of the calcaneus and stable fracture fixation. In addition, decompression of the protruded lateral wall of calcaneus can reduce the pressure of sural nerve and the peroneal tendons. Next, we will explain the sinus tarsi approach. Incision is made on the lateral side of the foot from the tip of the fibula to the base of the fourth metatarsal over the sinus tarsi. Following exposure of the fracture and articular surface of the calcaneus, accurate reduction and restoration of the articular surface of the calcaneus will be achieved followed by stable fracture fixation. Then careful dissection is made through the subcutaneous tissues to prevent damage to the sural nerve, peroneal tendons, and extensor digitorum brevis. This approach is minimally invasive surgery and can reduce wound complications such as necrosis or infection. The purpose of this study was to compare the clinical radiological results of the Sanders type 2 calcaneal fractures according to the above two surgical approachs.

Study Summary Information

Lay Summary

The calcaneus is the largest bone in the foot and is an irregular rectangle with four articular surfaces. It supports the body weight firmly and absorbs and transmits the body weight. Calcaneal fractures occur at a frequency as high as 2&#37; of the total fractures of the body. But, it is still a fracture with controversy over standard treatment methods. Calcaneal fractures can be classified as intra-articular fractures and extra-articular fractures, with intra-articular fractures accounting for 75&#37;. In the treatment of intra-articular fractures, it is difficult to accurately reduce the joint surface, resulting in complications such as traumatic arthritis.The calcaneal fracture is a common comminuted fracture and the approach is important because it is difficult to reduce and fix the fracture fragments during surgical treatment.
First, we will explain the extended lateral approach.
Starting at the posterior of the fibula, An L-shaped incision will be made to expose the lateral wall of the calcaneus. Effort will be made a full thickness skin flap including sural nerve. Following exposure of the lateral wall of the calcaneus, subtalar and calcaneocuboid joints, this allows accurate reduction of the articular surface of the calcaneus and stable fracture fixation. In addition, decompression of the protruded lateral wall of calcaneus can reduce the pressure of sural nerve and the peroneal tendons.
Next, we will explain the sinus tarsi approach.
Incision is made on the lateral side of the foot from the tip of the fibula to the base of the fourth metatarsal over the sinus tarsi. Following exposure of the fracture and articular surface of the calcaneus, accurate reduction and restoration of the articular surface of the calcaneus will be achieved followed by stable fracture fixation. Then careful dissection is made through the subcutaneous tissues to prevent damage to the sural nerve, peroneal tendons, and extensor digitorum brevis. This approach is minimally invasive surgery and can reduce wound complications such as necrosis or infection.
The purpose of this study was to compare the clinical radiological results of the Sanders type 2 calcaneal fractures according to the above two surgical approachs.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	/Procedure/Surgery
Intervention Description	First, we will explain the extended lateral approach. Starting at the posterior of the fibula, An L-shaped incision will be made to expose the lateral wall of the calcaneus. Effort will be made a full thickness skin flap including sural nerve. Following exposure of the lateral wall of the calcaneus, subtalar and calcaneocuboid joints, this allows accurate reduction of the articular surface of the calcaneus and stable fracture fixation. In addition, decompression of the protruded lateral wall of calcaneus can reduce the pressure of sural nerve and the peroneal tendons. Next, we will explain the sinus tarsi approach. Incision is made on the lateral side of the foot from the tip of the fibula to the base of the fourth metatarsal over the sinus tarsi. Following exposure of the fracture and articular surface of the calcaneus, accurate reduction and restoration of the articular surface of the calcaneus will be achieved followed by stable fracture fixation. Then careful dissection is made through the subcutaneous tissues to prevent damage to the sural nerve, peroneal tendons, and extensor digitorum brevis. This approach is minimally invasive surgery and can reduce wound complications such as necrosis or infection.
Number of Arms	2
Arm 1	Arm Label Sinus tarsi approach
	Target Number of Participant 30
	Arm Type Experimental
	Arm Description We will explain the sinus tarsi approach. Incision is made on the lateral side of the foot from the tip of the fibula to the base of the fourth metatarsal over the sinus tarsi. Following exposure of the fracture and articular surface of the calcaneus, accurate reduction and restoration of the articular surface of the calcaneus will be achieved followed by stable fracture fixation. Then careful dissection is made through the subcutaneous tissues to prevent damage to the sural nerve, peroneal tendons, and extensor digitorum brevis. This approach is minimally invasive surgery and can reduce wound complications such as necrosis or infection.
Arm 2	Arm Label Extended lateral approach.
	Target Number of Participant 30
	Arm Type Active comparator
	Arm Description We will explain the extended lateral approach. Starting at the posterior of the fibula, An L-shaped incision will be made to expose the lateral wall of the calcaneus. Effort will be made a full thickness skin flap including sural nerve. Following exposure of the lateral wall of the calcaneus, subtalar and calcaneocuboid joints, this allows accurate reduction of the articular surface of the calcaneus and stable fracture fixation. In addition, decompression of the protruded lateral wall of calcaneus can reduce the pressure of sural nerve and the peroneal tendons.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (S00-T98)Injury, poisoning and certain other consequences of external causes (S92.00)Fracture of calcaneus, closed
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~No Limit
	Description - Skeletally mature patients ≥ 18 years of age - Sanders type 2 calcaneal fractures. closed - Undergoing surgical treatment - Ability to understand and agree to informed consent
Exclusion Criteria	- Patients < 18 years of age - Open calcaneal fractures - Previous calcaneus abnormality or injury - Patients with concomitant severe brain & spine injury - Unable to understand or agree to informed consent
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale
Timepoint	approximately two years
Primary Outcome(s) 2
Outcome	Visual Analog Scale (VAS)
Timepoint	approximately two years
Secondary Outcome(s) 1
Outcome	foot function index
Timepoint	approximately two years
Secondary Outcome(s) 2
Outcome	Postoperative complication rate
Timepoint	approximately two years
Secondary Outcome(s) 3
Outcome	Bone union rate
Timepoint	approximately two years

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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