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

Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People - Investigator Initiated Trial-

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Reconstruction; Healthy People
• Intervention / Treatment: Device: Mobilie Bi-planar X-ray Imaging system

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joon Ho Wang, MD; Phone Number: +82-2-3410-3507; Email: mdwang88@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Normal group

  1. Adults between 19 and 60 years of age
  2. Those who have no knee instability, locking, or jamming, and no history of surgery
  3. A person who has the will and ability to follow the procedures of this clinical trial protocol
  4. Those who voluntarily agreed in writing to participate in this clinical trial

• Anterior cruciate ligament rupture patient group

  1. Adults between 19 and 60 years of age
  2. Those with grade 3 or higher in the Lachmann test
  3. A person suspected of having an anterior cruciate ligament injury tear on magnetic resonance imaging (MRI)
  4. A person who has the will and ability to follow the procedures of this clinical trial protocol
  5. Those who voluntarily agreed in writing to participate in this clinical trial

• Patient group more than 1 year after anterior cruciate ligament reconstruction

  1. Adults between 19 and 60 years of age
  2. A person who has performed double bundle reconstruction; or Those who have performed single bundle reconstruction and anterolateral ligament reconstruction
  3. A person who has the will and ability to follow the procedures of this clinical trial protocol
  4. Those who voluntarily agreed in writing to participate in this clinical trial

Exclusion criteria

1. Those with degenerative arthritis of the knee joint
2. 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
3. Patients with chronic inflammatory joint disease such as rheumatoid arthritis
4. Those whose growth plates are not closed
5. 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
6. Pregnant and lactating women
7. Persons judged by other researchers as inappropriate for participation in clinical trials

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobilie Bi-planar X-ray Imaging system	Device: Mobilie Bi-planar X-ray Imaging system; on the Mobilie Bi-planar X-ray Imaging system, images are acquired for three movements: walking, downhill walking, and squat

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	Baseline

Collaborators and Investigators

• Sponsor: Wang Joon Ho

Study record dates

Study Major Dates

• Study Start (Anticipated): November 7, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 2022-05-019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No