Anterior Cruciate Ligament RuptureNCT04957706
Diagnostic Study of ACL Rupture With Anterior Drawer Test at 90° of Hip Flexion
An observational study of Anterior Cruciate Ligament Rupture, run by Peking University Third Hospital at 1 site in China.
Trial summary
For patients with anterior cruciate ligament rupture, the existing physical examinations have certain limitations. The researchers improved the traditional anterior drawer test in clinical work, maintained the flexion of the knee and flexion of the hip, and observed the displacement of the tibia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- anterior drawer test at 90° of hip flexion, Lachman test and anterior drawer test
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 1 Sep 2022
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patient are from Peking University Third Hospital
Who may be able to join
- （1）ages between 18 and 60 years old. (2) Inpatients diagnosed with unique anterior cruciate ligament rupture and ready for anterior cruciate ligament reconstruction. (3) no combined injuries.
Who cannot join
- (1) The patient is younger than 18 years old or older than 60 years old, (2) multiple ligament injuries of the knee joint are suspected, and (3) combined fractures are suspected.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking university third hospital
Beijing, Beijing Municipality, 100191
yingfang ao, M.D., 13910125935, aoyingfang@163.com
About this study
Official title: Diagnostic Study of Anterior Cruciate Ligament Rupture With Anterior Drawer Test at 90° of Hip Flexion
For patients with anterior cruciate ligament rupture, the existing physical examinations have certain limitations. The researchers improved the traditional anterior drawer test in clinical work, maintained the flexion of the knee and flexion of the hip, and observed the displacement of the tibia. Good diagnostic effect, but no research statistics. The purpose of this study is to explore the effectiveness of the 90° of hip flextion anterior drawer test in the diagnosis of anterior cruciate ligament rupture.
Read the detailed description
A total of 300 hospitalized patients who were diagnosed with anterior cruciate ligament rupture by MR and prepared for anterior cruciate ligament reconstruction were included, of which 150 cases were injured in the acute phase (within 2 months after the injury) and the chronic phase (more than 2 months after the injury). After the patient was admitted to the hospital, the patients were sequentially subjected to the 90° anterior drawer test, Lachman test, pivot-shift test, and anterior drawer test. The examination results were recorded. Compare the effectiveness of different physical examinations in diagnosing the anterior cruciate ligament. The patient's age, gender, injury time, BMI, the type of ACL rupture in the surgical records, and whether meniscus or cartilage damage were combined were counted. Regression analysis was used to evaluate the influencing factors of the modified anterior drawer test to correctly diagnose the rupture of the ACL.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- anterior drawer test at 90° of hip flexion, Lachman test, anterior drawer test, pivot-shift test
- 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.
anterior drawer test at 90° of hip flexionDiagnostic test
anterior drawer test at 90° of hip flexion
Lachman testDiagnostic test
Lachman test
anterior drawer testDiagnostic test
anterior drawer test
pivot-shift testDiagnostic test
pivot-shift test
| Study group | Role | What they receive |
|---|---|---|
| Acute injury | injury ≤ 2 months Receives: Diagnostic Test: anterior drawer test at 90° of hip flexion; Diagnostic Test: Lachman test; Diagnostic Test: anterior drawer test; Diagnostic Test: pivot-shift test | |
| Chronic injury | injury > 2 months Receives: Diagnostic Test: anterior drawer test at 90° of hip flexion; Diagnostic Test: Lachman test; Diagnostic Test: anterior drawer test; Diagnostic Test: pivot-shift test |
What is being measured
The primary outcome is the main question the study is designed to answer.
anterior drawer test at 90° of hip flexion
anterior drawer test at 90° of hip flexion
Measured: 1 week after injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Sep 2022 (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 RuptureStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yingfang ao, M.D., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957706
- Sponsor's protocol ID
- LM2019116
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Study of Anterior Cruciate Ligament Rupture With Anterior Drawer Test at 90° of Hip Flexion
- ClinicalTrials.gov ID
- NCT04957706
- Acronym / sponsor ID
- LM2019116
- Conditions
- Anterior Cruciate Ligament Rupture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 12 Jul 2021 (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.
For patients with anterior cruciate ligament rupture, the existing physical examinations have certain limitations. The researchers improved the traditional anterior drawer test in clinical work, maintained the flexion of the knee and flexion of the hip, and observed the displacement of the tibia. Good diagnostic effect, but no research statistics. The purpose of this study is to explore the effectiveness of the 90° of hip flextion anterior drawer test in the diagnosis of anterior cruciate ligament rupture.
Detailed description
A total of 300 hospitalized patients who were diagnosed with anterior cruciate ligament rupture by MR and prepared for anterior cruciate ligament reconstruction were included, of which 150 cases were injured in the acute phase (within 2 months after the injury) and the chronic phase (more than 2 months after the injury). After the patient was admitted to the hospital, the patients were sequentially subjected to the 90° anterior drawer test, Lachman test, pivot-shift test, and anterior drawer test. The examination results were recorded. Compare the effectiveness of different physical examinations in diagnosing the anterior cruciate ligament. The patient's age, gender, injury time, BMI, the type of ACL rupture in the surgical records, and whether meniscus or cartilage damage were combined were counted. Regression analysis was used to evaluate the influencing factors of the modified anterior drawer test to correctly diagnose the rupture of the ACL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute injury | – | Diagnostic Test: anterior drawer test at 90° of hip flexion, Diagnostic Test: Lachman test, Diagnostic Test: anterior drawer test, Diagnostic Test: pivot-shift testinjury ≤ 2 months |
| Chronic injury | – | Diagnostic Test: anterior drawer test at 90° of hip flexion, Diagnostic Test: Lachman test, Diagnostic Test: anterior drawer test, Diagnostic Test: pivot-shift testinjury > 2 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient are from Peking University Third Hospital
Key inclusion criteria (1 listed)
- （1）ages between 18 and 60 years old. (2) Inpatients diagnosed with unique anterior cruciate ligament rupture and ready for anterior cruciate ligament reconstruction. (3) no combined injuries.
Key exclusion criteria (1 listed)
- (1) The patient is younger than 18 years old or older than 60 years old, (2) multiple ligament injuries of the knee joint are suspected, and (3) combined fractures are suspected.
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 |
|---|---|---|
| anterior drawer test at 90° of hip flexionanterior drawer test at 90° of hip flexion | Diagnostic test | Acute injury, Chronic injury |
| Lachman testLachman test | Diagnostic test | Acute injury, Chronic injury |
| anterior drawer testanterior drawer test | Diagnostic test | Acute injury, Chronic injury |
| pivot-shift testpivot-shift test | Diagnostic test | Acute injury, Chronic injury |
Primary outcome
anterior drawer test at 90° of hip flexion
Time frame: 1 week after injury
anterior drawer test at 90° of hip flexion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
yingfang ao, M.D. study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anterior Cruciate Ligament Rupture, run by Peking University Third Hospital at 1 site in China.
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 1 inclusion and 1 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 12 Jul 2021. 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 China. 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 xingyue niu, M.D. (13126710633, Meteornnn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anterior drawer test at 90° of hip flexion (time frame: 1 week after injury). 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 12 Jul 2021.