Anterior Cruciate Ligament InjuriesNCT05619393
Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People
A study testing Mobilie Bi-planar X-ray Imaging system in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Reconstruction, run by Wang Joon Ho at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Reconstruction, Healthy People
- What is being tested?
- Mobilie Bi-planar X-ray Imaging system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Nov 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Reconstruction, Healthy People
- Being tested
- Mobilie Bi-planar X-ray Imaging system
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilie Bi-planar X-ray Imaging systemDevice
on the Mobilie Bi-planar X-ray Imaging system, images are acquired for three movements: walking, downhill walking, and squat
| Study group | Role | What they receive |
|---|---|---|
| Mobilie Bi-planar X-ray Imaging system | Experimental | Not described Receives: Device: Mobilie Bi-planar X-ray Imaging system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start7 Nov 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wang Joon Ho
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wang Joon Ho, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619393
- Sponsor's protocol ID
- 2022-05-019
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Kinematic Movements Between ACL Deficiency With ACL Reconstruction and Healthy People - Investigator Initiated Trial-
- ClinicalTrials.gov ID
- NCT05619393
- Acronym / sponsor ID
- 2022-05-019
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Reconstruction, Healthy People
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wang Joon HoUniversity, hospital or other
- Study start
- 7 Nov 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobilie Bi-planar X-ray Imaging system | Experimental | Device: Mobilie Bi-planar X-ray Imaging system |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Normal group
- Anterior cruciate ligament rupture patient group
- Patient group more than 1 year after anterior cruciate ligament reconstruction
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobilie Bi-planar X-ray Imaging systemon the Mobilie Bi-planar X-ray Imaging system, images are acquired for three movements: walking, downhill walking, and squat | Device | Mobilie Bi-planar X-ray Imaging system |
Primary outcome
Difference for 6-Degree of freedom
Time frame: Baseline
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 .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilie Bi-planar X-ray Imaging system in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Reconstruction, run by Wang Joon Ho at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joon Ho Wang, MD (+82-2-3410-3507, mdwang88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference for 6-Degree of freedom (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.