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Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People

Primary Purpose

Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Reconstruction, Healthy People

Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mobilie Bi-planar X-ray Imaging system
Sponsored by
Wang Joon Ho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Anterior Cruciate Ligament Injuries

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Normal group Adults between 19 and 60 years of age Those who have no knee instability, locking, or jamming, and no history of surgery A person who has the will and ability to follow the procedures of this clinical trial protocol Those who voluntarily agreed in writing to participate in this clinical trial Anterior cruciate ligament rupture patient group Adults between 19 and 60 years of age Those with grade 3 or higher in the Lachmann test A person suspected of having an anterior cruciate ligament injury tear on magnetic resonance imaging (MRI) A person who has the will and ability to follow the procedures of this clinical trial protocol Those who voluntarily agreed in writing to participate in this clinical trial Patient group more than 1 year after anterior cruciate ligament reconstruction Adults between 19 and 60 years of age A person who has performed double bundle reconstruction; or Those who have performed single bundle reconstruction and anterolateral ligament reconstruction A person who has the will and ability to follow the procedures of this clinical trial protocol Those who voluntarily agreed in writing to participate in this clinical trial Exclusion criteria Those with degenerative arthritis of the knee joint Those who need reoperation after anterior cruciate ligament rupture surgery, or those who have other knee surgery history, who are difficult to participate in the study under the judgment of the principal investigator Patients with chronic inflammatory joint disease such as rheumatoid arthritis Those whose growth plates are not closed Patients who need companion surgery for ligament instability of grade II (grade 0: none, grade I: 0-5 mm, grade II: 5-10 mm, grade III: >10 mm) on physical examination Pregnant and lactating women Persons judged by other researchers as inappropriate for participation in clinical trials

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobilie Bi-planar X-ray Imaging system

Arm Description

Outcomes

Primary Outcome Measures

Difference for 6-Degree of freedom
Evaluate the difference in the result of measuring the six degrees of freedom of the knee joint, including the front and rear potentials of the knee joint, the inner and outer potentials, and the inner rotation/outer rotation. Measure the vertical distance between the femur posterior condyle and posterior tibia. The unit of measurement is millimeter .

Secondary Outcome Measures

Full Information

First Posted
November 1, 2022
Last Updated
November 15, 2022
Sponsor
Wang Joon Ho
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1. Study Identification

Unique Protocol Identification Number
NCT05619393
Brief Title
Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People
Official Title
Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People - Investigator Initiated Trial-
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 7, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wang Joon Ho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Comparison of kinematic movements between patients with anterior cruciate ligament rupture and post-operative patients and normal people using a mobile dynamic X-ray device.
Detailed Description
On a treadmill equipped with a mobile dynamic X-ray device, the subject will take three movements: walking, downhill walking, and squat, and the movement of the knee joint will be tracked. The investigators plan to quantify and compare the motion of the knee joint taken in patients with anterior cruciate ligament rupture, anterior cruciate ligament reconstruction, and normal people according to 6 degrees of freedom. Through this, the investigators plan to compare the functional instability between normal people and the ACL rupture patient group in daily life, and compare this with the ACL reconstruction patient group to see if surgery can reduce knee joint instability in everyday life. To confirm this, with mobile dynamic X-rays taken as the primary variable, the investigators took 1) normal subjects, 2) patients with anterior cruciate ligament rupture, 3) patients with more than 1 year after double bundle ACL reconstruction, and 4) single bundle anterior patients. the investigators plan to compare 6 degrees of freedom between patient groups who have had more than 1 year after cruciate ligament reconstruction and anterolateral ligament reconstruction. As secondary variables, the Lachman test and the Pivot shift test will be compared between the four groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Reconstruction, Healthy People

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobilie Bi-planar X-ray Imaging system
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Mobilie Bi-planar X-ray Imaging system
Intervention Description
on the Mobilie Bi-planar X-ray Imaging system, images are acquired for three movements: walking, downhill walking, and squat
Primary Outcome Measure Information:
Title
Difference for 6-Degree of freedom
Description
Evaluate the difference in the result of measuring the six degrees of freedom of the knee joint, including the front and rear potentials of the knee joint, the inner and outer potentials, and the inner rotation/outer rotation. Measure the vertical distance between the femur posterior condyle and posterior tibia. The unit of measurement is millimeter .
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Normal group Adults between 19 and 60 years of age Those who have no knee instability, locking, or jamming, and no history of surgery A person who has the will and ability to follow the procedures of this clinical trial protocol Those who voluntarily agreed in writing to participate in this clinical trial Anterior cruciate ligament rupture patient group Adults between 19 and 60 years of age Those with grade 3 or higher in the Lachmann test A person suspected of having an anterior cruciate ligament injury tear on magnetic resonance imaging (MRI) A person who has the will and ability to follow the procedures of this clinical trial protocol Those who voluntarily agreed in writing to participate in this clinical trial Patient group more than 1 year after anterior cruciate ligament reconstruction Adults between 19 and 60 years of age A person who has performed double bundle reconstruction; or Those who have performed single bundle reconstruction and anterolateral ligament reconstruction A person who has the will and ability to follow the procedures of this clinical trial protocol Those who voluntarily agreed in writing to participate in this clinical trial Exclusion criteria Those with degenerative arthritis of the knee joint Those who need reoperation after anterior cruciate ligament rupture surgery, or those who have other knee surgery history, who are difficult to participate in the study under the judgment of the principal investigator Patients with chronic inflammatory joint disease such as rheumatoid arthritis Those whose growth plates are not closed Patients who need companion surgery for ligament instability of grade II (grade 0: none, grade I: 0-5 mm, grade II: 5-10 mm, grade III: >10 mm) on physical examination Pregnant and lactating women Persons judged by other researchers as inappropriate for participation in clinical trials
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joon Ho Wang, MD
Phone
+82-2-3410-3507
Email
mdwang88@gmail.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People

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