임상연구정보서비스

Search: Search

The comparison of clinical and radiologic outcomes among Lateral extensile exposure technique, sinus tarsi approach technique and subtalar arthroscope technique in acute intra-articular calcaneal fracture: Prospective randomized controlled study

Status Approved

First Submitted Date

2020/02/20
Registered Date

2020/02/25
Last Updated Date

2020/02/20

Move list page

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	KCT0004769
Unique Protocol ID	WKUH 201904034001
Public/Brief Title	The comparison of clinical and radiologic outcomes among Lateral extensile exposure technique, sinus tarsi approach technique and subtalar arthroscope technique for patients with calcaneal fracture.
Scientific Title	The comparison of clinical and radiologic outcomes among Lateral extensile exposure technique, sinus tarsi approach technique and subtalar arthroscope technique in acute intra-articular calcaneal fracture: Prospective randomized controlled study
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	WKUH 201904034001
Approval Date	2019-06-28
Institutional Review Board Name	Wonkwang University Hospital Institutional Review Board
Institutional Review Board Address	895, Muwang-ro, Iksan-si, Jeollabuk-do
Institutional Review Board Telephone	063-859-2232
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	Sung Hyun Lee
Title	Assistant Professor
Telephone	+82-63-859-1360
Affiliation	Wonkwang University Hospital
Address	895, Muwang-ro, Iksan-si, Jeollabuk-do
Contact Person for Public Queries
Name	Sung Hyun Lee
Title	Assistant Professor
Telephone	+82-63-859-1360
Affiliation	Wonkwang University Hospital
Address	895, Muwang-ro, Iksan-si, Jeollabuk-do
Contact Person for Updating Information
Name	Sung Hyun Lee
Title	Assistant Professor
Telephone	+82-63-859-1360
Affiliation	Wonkwang University Hospital
Address	895, Muwang-ro, Iksan-si, Jeollabuk-do

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	2019-06-28 Actual
Target Number of Participant	60
Primary Completion Date
Study Completion Date
Name of Study	Wonkwang University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2019-06-28 ,

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	Wonkwang University Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Wonkwang University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	In patients who have calcaneal fracture, the rate of complications varies according to the fracture pattern and soft tissue management, and clinical and radiological results also vary. However, even in various treatments, the complications of the calcaneus fracture itself are often high and the prognosis is poor. Most of the fractures that do not involve subtalar joints can be satisfactorily conserved, but intraarticular fractures showed worse outcomes without surgical treatment. There has been much controversy over various treatment options. Many authors recommend open reduction and internal fixation to conquer the posterior joint and restore the shape of the calcaneus. Estensile lateral approaches are widely used for open reduction and internal fixation. However, postoperative complications such as infection and cutaneous necrosis and sural nerve injury have been pointed out as problems after surgery of the fracture of the calcaneus by the extensile lateral approach. New minimally invasive approach has steadily emerged to reduce the complications. Among them, surgical treatment using the sinus tarsi approach is known as a typical surgical method. However, vision is limited and there may be limitations in conquering the surface of the joint, and other complications such as nonunion and failure of conquest may occur. Because of the narrow space between the subtalar and posterior joints, it is not easy to conquer by open reduction. Subtalar arthroscopy is widely used as a useful tool for diagnosing and treating intraarticular and extraarticular fractures around the subtalar joints. Some authors have described that subtalar arthroscopy can be used in the surgical treatment of displaced intra-articular calcaneal fracture (DIACF). The purpose of this study is to compare the clinical and anatomical results of the conventional extensile lateral approach, the sinus tarsi approach, and the subtalar arthroscopy through prospective randomization. The results of this study may support the feasibility of surgery through subtalar arthroscopy, which may contribute to the development of noninvasive methods for acute calcaneal fractures of intraarticular fractures.

Study Summary Information

Lay Summary

In patients who have calcaneal fracture, the rate of complications varies according to the fracture pattern and soft tissue management, and clinical and radiological results also vary. However, even in various treatments, the complications of the calcaneus fracture itself are often high and the prognosis is poor. Most of the fractures that do not involve subtalar joints can be satisfactorily conserved, but intraarticular fractures showed worse outcomes without surgical treatment. There has been much controversy over various treatment options.
Many authors recommend open reduction and internal fixation to conquer the posterior joint and restore the shape of the calcaneus. Estensile lateral approaches are widely used for open reduction and internal fixation. However, postoperative complications such as infection and cutaneous necrosis and sural nerve injury have been pointed out as problems after surgery of the fracture of the calcaneus by the extensile lateral approach.
New minimally invasive approach has steadily emerged to reduce the complications. Among them, surgical treatment using the sinus tarsi approach is known as a typical surgical method. However, vision is limited and there may be limitations in conquering the surface of the joint, and other complications such as nonunion and failure of conquest may occur.
Because of the narrow space between the subtalar and posterior joints, it is not easy to conquer by open reduction. Subtalar arthroscopy is widely used as a useful tool for diagnosing and treating intraarticular and extraarticular fractures around the subtalar joints. Some authors have described that subtalar arthroscopy can be used in the surgical treatment of displaced intra-articular calcaneal fracture (DIACF). The purpose of this study is to compare the clinical and anatomical results of the conventional extensile lateral approach, the sinus tarsi approach, and the subtalar arthroscopy through prospective randomization. The results of this study may support the feasibility of surgery through subtalar arthroscopy, which may contribute to the development of noninvasive methods for acute calcaneal fractures of intraarticular fractures.

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	Single
Blinded Subject	Subject, Outcome Accessor
Allocation	RCT
Intervention Type	/Procedure/Surgery
Intervention Description	Calcaneus fractures will be treated thruogh conventional extensile lateral approach, the sinus tarsi approach, and the subtalar arthroscopy by prospective randomization.
Number of Arms	3
Arm 1	Arm Label Extensile lateral approach group
	Target Number of Participant 20
	Arm Type Experimental
	Arm Description Calcaneus fractures will be treated with open reduction and internal fixation thruogh conventional extensile lateral approach.
Arm 2	Arm Label Sinus tarsi approach group
	Target Number of Participant 20
	Arm Type Experimental
	Arm Description Calcaneus fractures will be treated with open reduction and internal fixation thruogh sinus tarsi approach.
Arm 3	Arm Label Arthroscopic approach group
	Target Number of Participant 20
	Arm Type Experimental
	Arm Description Calcaneus fractures will be treated with Arthroscopic reduction and internal fixation.

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 Calcaneus Fracture
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~No Limit
	Description (1) Patients with acute calcaneal fractures with displaced intraarticular fractures that involve the posterior facet joint (2) Patients who agreed to treatment method (open or arthroscopic approach) and postoperative examination (3) Patients who can have CT scan before and after surgery (4) Patients who are expected to be able to follow for more than 2 years (5) Patients who agreed to the agreement
Exclusion Criteria	(1) open calcaneus fractures (2) past fractures of the affected foot and ankle joints (3) past surgical history of the affected foot and ankles (4) altered ankle alignment due to arthritis, congenital diseases, etc (5) other musculoskeletal systems and History of nervous system diseases
Healthy Volunteers

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	/Safety/Efficacy
Outcome	Foot and Ankle Outcome Score
Timepoint	Preoperatively, Postoperative 3months, 6months, 1year and yearly
Secondary Outcome(s) 1
Outcome	Posttraumatic subtalar arthritis and radiologic findings
Timepoint	Preoperatively, Postoperative 3months, 6months, 1year and yearly
Secondary Outcome(s) 2
Outcome	Radiologic findings (Bolher angle, Gissane angle, calcaneal height, width)
Timepoint	Preoperatively, Postoperative 3months, 6months, 1year and yearly
Secondary Outcome(s) 3
Outcome	American Orthopedic foot and ankle score
Timepoint	Preoperatively, Postoperative 3months, 6months, 1year and yearly
Secondary Outcome(s) 4
Outcome	Tegner Activity Scales
Timepoint	Preoperatively, Postoperative 3months, 6months, 1year and yearly
Secondary Outcome(s) 5
Outcome	Visual analogue scale
Timepoint	Preoperatively, Postoperative 3months, 6months, 1year and yearly

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	Yes
Time of Sharing	2022. 12
Way of Sharing	Available on Request (kensin06@hanmail.net)

Move list page Move to top