Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2022
CompletedStudy Start
First participant enrolled
November 7, 2022
CompletedFirst Posted
Study publicly available on registry
November 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedNovember 16, 2022
November 1, 2022
8 months
November 1, 2022
November 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Mobilie Bi-planar X-ray Imaging system
EXPERIMENTALInterventions
on the Mobilie Bi-planar X-ray Imaging system, images are acquired for three movements: walking, downhill walking, and squat
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wang Joon Holead
Study Sites (1)
Samsung Medical Center
Seoul, 06351, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, Professor, Department of Orthopaedic Surgery
Study Record Dates
First Submitted
November 1, 2022
First Posted
November 16, 2022
Study Start
November 7, 2022
Primary Completion
June 30, 2023
Study Completion
December 31, 2023
Last Updated
November 16, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share