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Percutaneous distal metatarsal osteotomy versus open distal chevron osteotomy for the treatment of hallux valgus: A prospective randomized controlled trial

Status Approved

First Submitted Date

2019/11/12
Registered Date

2019/11/19
Last Updated Date

2019/11/12

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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	KCT0004452
Unique Protocol ID	2019A S0119
Public/Brief Title	Percutaneous distal metatarsal osteotomy versus open distal chevron osteotomy for the treatment of hallux valgus: A prospective randomized controlled trial
Scientific Title	Percutaneous distal metatarsal osteotomy versus open distal chevron osteotomy for the treatment of hallux valgus: A prospective randomized controlled trial
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
Registered at Other Registry	No
Healthcare Benefit Approval Status	Submitted pending

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2019AS0119
Approval Date	2019-06-04
Institutional Review Board Name	Korea University Medical Center Ansan Hospital Institutional Review Board
Institutional Review Board Address	123, Jeokgeum-ro, Danwon-gu, Ansan-si, Gyeonggi-do
Institutional Review Board Telephone	031-412-6514
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	Gi Won Choi
Title	associate professor
Telephone	+82-31-412-4944
Affiliation	Korea University Ansan Hospital
Address	123, Jeokgeum-ro, Danwon-Gu, Ansan-si, Gyeonggi-do 15355, South Korea
Contact Person for Public Queries
Name	Gi Won Choi
Title	associate professor
Telephone	+82-31-412-4944
Affiliation	Korea University Ansan Hospital
Address	123, Jeokgeum-ro, Danwon-Gu, Ansan-si, Gyeonggi-do 15355, South Korea
Contact Person for Updating Information
Name	Gi Won Choi
Title	associate professor
Telephone	+82-31-412-4944
Affiliation	Korea University Ansan Hospital
Address	123, Jeokgeum-ro, Danwon-Gu, Ansan-si, Gyeonggi-do 15355, South Korea

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	Multi-center Number of center : 4
Overall Recruitment Status	Recruiting
Date of First Enrollment	2019-10-14 Actual
Target Number of Participant	90
Primary Completion Date	2023-12-31 , Anticipated
Study Completion Date	2023-12-31 , Anticipated
Name of Study	Korea University Ansan Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2019-10-14 ,
Recruitment Status by Participating Study Site 2
Name of Study	Yonsei University Health System, Severance Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-12-01 ,
Recruitment Status by Participating Study Site 3
Name of Study	Gangbuk Yonsei Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-12-28 ,
Recruitment Status by Participating Study Site 4
Name of Study	Ace Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-12-28 ,

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	Korea University Ansan Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

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

7. Study Summary

Study Summary Information
Lay Summary	Among the surgical treatment of hallux valgus, the typical method of metatarsal osteotomy is open distal chevron osteotomy. Recently, percutaneous distal metatarsal osteomy has been introduced and its use has been increased. Open distal chevron osteotomy has the advantage of stable osteotomy. The percutaneous distal metatarsal osteomy is less invasive than open distal chevron osteotomy, and the smaller skin incisions suggest a faster recovery after surgery. However, there is little study comparing this two procedures. The purpose of this study is to compare clinical and radiologic outcomes between these two techniques for the treatment of hallux valgus.

Study Summary Information

Lay Summary

Among the surgical treatment of hallux valgus, the typical method of metatarsal osteotomy is open distal chevron osteotomy. Recently, percutaneous distal metatarsal osteomy has been introduced and its use has been increased. Open distal chevron osteotomy has the advantage of stable osteotomy. The percutaneous distal metatarsal osteomy is less invasive than open distal chevron osteotomy, and the smaller skin incisions suggest a faster recovery after surgery. However, there is little study comparing this two procedures. The purpose of this study is to compare clinical and radiologic outcomes between these two techniques for the treatment of hallux valgus.

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	For the treatment of hallux valgus, patients assigned to group A undergo open distal chevron osteotomy, and patients assigned to group B undergo percutaneous distal metatarsal osteomy.
Number of Arms	2
Arm 1	Arm Label group A
	Target Number of Participant 45
	Arm Type Active comparator
	Arm Description Patients assigned to group A undergo open distal chevron osteotomy.
Arm 2	Arm Label group B
	Target Number of Participant 45
	Arm Type Experimental
	Arm Description patients assigned to group B undergo percutaneous distal metatarsal osteomy

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M20.1)Hallux valgus (acquired) Hallux valgus
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~80Year
	Description 1. 19 ~ 80 years old 2. patient with hallux valgus who need surgical treatment
Exclusion Criteria	1) Osteoarthritis of the first metatarsophalangeal joint. 2) rheumatoid arthritis or other inﬂammatory diseases 3) previous surgery on the ipsilateral foot and ankle 4) case which need lesser toe surgery 5) the first tarsometatarsal instability diagnosed by clinical examination
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	Efficacy
Outcome	radiologic outcomes
Timepoint	preoperative, postoperative 3,6,12 months
Secondary Outcome(s) 1
Outcome	Foot and Ankle outcome score
Timepoint	preoperative, postoperative 3,6,12 months
Secondary Outcome(s) 2
Outcome	Foot functional index
Timepoint	preoperative, postoperative 3,6,12 months
Secondary Outcome(s) 3
Outcome	patient satisfaction
Timepoint	preoperative, postoperative 3,6,12 months
Secondary Outcome(s) 4
Outcome	VAS for pain
Timepoint	preoperative, postoperative 1 day, 2 weeks, 6 weeks, 3,6,12 months
Secondary Outcome(s) 5
Outcome	range of motion of 1st metatarsophalangeal joint
Timepoint	preoperative, postoperative 3,6,12 months

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	No

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