임상연구정보서비스

The Effect of Patient-Specific Instrumentation Incorporating an Extramedullary Tibial Guide on Operative Efficiency for Total Knee Arthroplasty

Status Approved

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	KCT0002384
Unique Protocol ID	15-D02-04
Public/Brief Title	The Effect of Patient-Specific Instrumentation Incorporating an Extramedullary Tibial Guide on Operative Efficiency
Scientific Title	The Effect of Patient-Specific Instrumentation Incorporating an Extramedullary Tibial Guide on Operative Efficiency for Total Knee Arthroplasty
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	15-D02-04
Approval Date	2015-08-31
Institutional Review Board Name	Yonsei Sarang Hospital Institutional Review Board
Institutional Review Board Address
Institutional Review Board Telephone
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	Oh-ryong Kwon
Title	Director
Telephone	+82-2-2023-5522
Affiliation	Yonsei Sarang Hospital
Address	#10 Hyoryeong-ro, Seocho-gu, Seoul, Korea
Contact Person for Public Queries
Name	Oh-ryong Kwon
Title	Director
Telephone	+82-2-2023-5522
Affiliation	Yonsei Sarang Hospital
Address	#10 Hyoryeong-ro, Seocho-gu, Seoul, Korea
Contact Person for Updating Information
Name	Oh-ryong Kwon
Title	Director
Telephone	+82-2-2023-5522
Affiliation	Yonsei Sarang Hospital
Address	#10 Hyoryeong-ro, Seocho-gu, Seoul, 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	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2015-09-01 Actual
Target Number of Participant	166
Primary Completion Date	2015-09-30 , Actual
Study Completion Date	2015-10-31 , Actual
Name of Study	Yonsei Sarang Hospital
Recruitment Status	Completed
Date of First Enrollment	2015-09-01 ,

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	Yonsei Sarang Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Yonsei Sarang Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	We evaluate the improvements in operative room efficiency and postoperative limb alignment with regard to tibial guide design of PSI

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-control
Time Perspective	Retrospective
Target Number of Participant	166
Cohort/Group Number	3
Cohort/ Group 1	Cohort/Group Label PSI 1 group
Cohort/ Group 1	Cohort/Group Description To evaluate the postoperative limb alignment and the operative time of TKA using PSI without extra-medullary tibial guide group
Cohort/ Group 2	Cohort/Group Label PSI 2 group
Cohort/ Group 2	Cohort/Group Description To evaluate the postoperative limb alignment and the operative time of TKA using PSI with EM tibial guide group
Cohort/ Group 3	Cohort/Group Label control group
Cohort/ Group 3	Cohort/Group Description To evaluate the postoperative limb alignment and the operative time of TKA using conventional instrumentation group
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	The patients performing total knee arthroplasty using patient specific instruments of two different disign in degenerative osteoarthritis of the knee
Sampling Method	Total of 166 patients with end-stage knee osteoarthritis scheduled for TKA between November 2013 to February 2015 were included in this study.
Condition(s)/Problem(s)	* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M17.9)Gonarthrosis, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age No Limit~No Limit
	Description End stage degenerative osteoarthritis
Exclusion Criteria	1. Reaumatoid arthritis 2. previous operation history 3. old fracture 4. previous operation history on operation site 5. claustrophobia
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	clinical-equivalence
Outcome	operative room time
Timepoint	immediately after operation
Secondary Outcome(s) 1
Outcome	thickness of bone resection
Timepoint	immediately after operation
Secondary Outcome(s) 2
Outcome	tibial posterior slope
Timepoint	immediately after operation
Secondary Outcome(s) 3
Outcome	rotation of the component
Timepoint	immediately after operation

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

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