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Effect of viscosupplementation in arthroscopic partial meniscectomy

Status Approved

First Submitted Date

2020/04/13
Registered Date

2020/04/16
Last Updated Date

2021/04/06

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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	KCT0004921
Unique Protocol ID	2019-11-019
Public/Brief Title	Effect of viscosupplementation in arthroscopic partial meniscectomy
Scientific Title	Effect of viscosupplementation in arthroscopic partial meniscectomy
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
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	KHUH-2020-03-041-003
Approval Date	2020-04-10
Institutional Review Board Name	Kyunghee university hospital IRB
Institutional Review Board Address	23, Kyungheedae-ro, Dongdaemun-gu, Seoul
Institutional Review Board Telephone	02-958-9579
Data Monitoring Committee	No

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	Kyoung Ho Yoon
Title	Professor
Telephone	+82-2-958-2222
Affiliation	Kyung Hee University Hospital
Address	Khyungheedaero 23
Contact Person for Public Queries
Name	Jae-Young Park
Title	Assistant Professor
Telephone	+82-2-958-2222
Affiliation	Kyung Hee University Hospital
Address	23, Kyung Hee Dae-ro, Dongdaemun-gu
Contact Person for Updating Information
Name	Jae-Young Park
Title	Assistant Professor
Telephone	+82-2-958-2222
Affiliation	Kyung Hee University Hospital
Address	23, Kyung Hee Dae-ro, Dongdaemun-gu

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	2020-05-13 Actual
Target Number of Participant	50
Primary Completion Date	2021-04-06 , Actual
Study Completion Date	2021-04-06 , Actual
Name of Study	Kyung Hee University Hospital
Recruitment Status	Completed
Date of First Enrollment	2020-05-13 ,

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 Health Industry Development Institute
Organization Type	Government
Project ID

6. Sponsor Organization

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

7. Study Summary

Study Summary Information
Lay Summary	It is stated that the above clinical trial is conducted for research purposes. When surgery is performed on the knee with arthroscopy, the physiological saline is put in the knee, and the natural joint fluid in the knee is washed away. It has been reported that this creates a more physiologically unfavorable environment for the knee, which adversely affects knee pain and swelling after surgery. Because of this, we expect to provide a function to replace joint fluid by adding a viscous supplement after surgery. The purpose of this clinical study is to study this. This clinical trial uses a randomization method, which is a method based on stochastic theory, to maximize the comparability of the test group and the control group and to ensure that the scientific feasibility of the clinical trial is not prevented by the involvement of researchers in the group assignment. . In order to perform blinding, the treatment should be conducted in the same way so that the patient, the observer, and the experimental coordinator cannot know the information in the treatment of the experimental group and the control group. However, in reality, medical staff's blinding is not possible. We believe that this experimentation plan does not blinding from the very basic stage, but that the study itself compares the objective results of viscosupplmentation, so that blinding itself will not have a significant impact on judging the results. In this area, blinding will not be performed.  Test group -Surgical method 1) Insert an incision for arthroscopy on the affected knee 2) A partial resection of the damaged cartilage plate is performed. 3) When the operation is complete, remove the physiological saline as much as possible through the arthroscopy, and then connect and inject the spinal needle into the Jointseal 1 vial. 4) The incision is closed with standard suture technique.  Control Same as the test group, except that no jointseal was injected.

Study Summary Information

Lay Summary

It is stated that the above clinical trial is conducted for research purposes. When surgery is performed on the knee with arthroscopy, the physiological saline is put in the knee, and the natural joint fluid in the knee is washed away. It has been reported that this creates a more physiologically unfavorable environment for the knee, which adversely affects knee pain and swelling after surgery. Because of this, we expect to provide a function to replace joint fluid by adding a viscous supplement after surgery. The purpose of this clinical study is to study this.

This clinical trial uses a randomization method, which is a method based on stochastic theory, to maximize the comparability of the test group and the control group and to ensure that the scientific feasibility of the clinical trial is not prevented by the involvement of researchers in the group assignment. .

In order to perform blinding, the treatment should be conducted in the same way so that the patient, the observer, and the experimental coordinator cannot know the information in the treatment of the experimental group and the control group. However, in reality, medical staff&#39;s blinding is not possible. We believe that this experimentation plan does not blinding from the very basic stage, but that the study itself compares the objective results of viscosupplmentation, so that blinding itself will not have a significant impact on judging the results. In this area, blinding will not be performed.

 Test group

-Surgical method
1) Insert an incision for arthroscopy on the affected knee
2) A partial resection of the damaged cartilage plate is performed.
3) When the operation is complete, remove the physiological saline as much as possible through the arthroscopy, and then connect and inject the spinal needle into the Jointseal 1 vial.
4) The incision is closed with standard suture technique.

 Control
Same as the test group, except that no jointseal was injected.

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
Allocation	RCT
Intervention Type	Medical Device, /Procedure/Surgery
Intervention Description	 Test group -Surgical method 1) Insert an incision for arthroscopy on the affected knee 2) A partial resection of the damaged cartilage plate is performed. 3) When the operation is complete, remove the physiological saline as much as possible through the arthroscopy, and then connect and inject the spinal needle into the Jointseal 1 vial. 4) The incision is closed with standard suture technique.  Control Same as the test group, except that no jointseal was injected. control group standard a/s meniscectomy
Number of Arms	2
Arm 1	Arm Label control group
	Target Number of Participant 25
	Arm Type Sham comparator
	Arm Description surgical protocol is same without jointseal supplementation at the end of surgery
Arm 2	Arm Label jointseal group
	Target Number of Participant 25
	Arm Type Experimental
	Arm Description -Surgical method 1) Insert an incision for arthroscopy on the affected knee 2) A partial resection of the damaged cartilage plate is performed. 3) When the operation is complete, remove the physiological saline as much as possible through the arthroscopy, and then connect and inject the spinal needle into the Jointseal 1 vial. 4) The incision is closed with standard suture technique.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (S00-T98)Injury, poisoning and certain other consequences of external causes (S83.29)Tear of meniscus, unspecified S83.2 Tear of meniscus
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description A. Target age: 19 years or older B. patient with meniscus tear that undergoes partial or subtotal meniscectomy C. Factors with Kelgren and Lawrence grade 0-2 on the X-ray prior to surgery D. Patients with ICRS grade 3 or less on cartilage damage on MRI before surgery
Exclusion Criteria	A. Kellgren and Lawrence grade 3 or higher lesions B. Patients with ICRS grade 4 cartilage lesions C. Pregnant women
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	100mm visual analogue scale score
Timepoint	postoperative 1 day
Secondary Outcome(s) 1
Outcome	International Knee Documentation Committee score, Lysholm, Tegner, Western Ontario and McMaster Universities Osteoarthritis Index score, Range of Motion
Timepoint	postoperative day 1, 2 week ,6 week, 3 month

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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