Knee Ligament; LaxityNCT04956315
Accuracy and Stability of a New Automatic Knee Arthrometer in Diagnosing ACL Rupture
An observational study of Knee Ligament; Laxity, run by Peking University Third Hospital at 1 site in China.
Trial summary
We introduced an automatic knee arthrometer (AKA) and aimed to evaluate the repeatability and effectiveness thereof in diagnosing ACL rupture compared with the KT-2000. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Ligament; Laxity
- What is being tested?
- Side-to-side difference (reproducibility), Side-to-side difference (availability) and Side-to-side difference (Accuracy)
- How many people
- 421 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2020to 31 Dec 2020
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: one healthy subject was tested with both devices for ten consecutive days to estimate examiner effect； 20 healthy subjects were tested with both devices to determine the method effect； 200 medicine students volunteered as healthy subjects; each with pain-free knees in the last three months, and without a history of knee injury； 200 patients with ACL rupture from our institution were also included.
Who may be able to join
- patients with ACL rupture from our institution were included. All patients were diagnosed by sports medicine specialists based on clinical manifestation, combined with imaging examinations, and hospitalized for further surgery.
Who cannot join
- Patients aged <18 or >45 years, with combined multiple knee ligament injury combinations, and/or limited range of motion of the knee (unable to flex to 20-30°)
Trial locations and contacts
1 site in 1 country.
China1 site
Peking university third hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Accuracy and Stability of a New Automatic Knee Arthrometer in Diagnosing Anterior Cruciate Ligament Rupture
We introduced an automatic knee arthrometer (AKA) and aimed to evaluate the repeatability and effectiveness thereof in diagnosing ACL rupture compared with the KT-2000.
Read the detailed description
The AKA was compared to the KT-2000 at 134 N in this study, the anterior displacement and difference of both knees of every subject were measured. The first protocol was designed to evaluate examiner effect (level of experience) and contralateral-side effect (left or right knee) in a single healthy subject, ten times, on ten consecutive days. The second was to compare the stability in 20 healthy subjects, with a single experienced examiner. Third, we recruited 200 ACL rupture and 200 healthy subjects as contrast to compare the accuracy of the devices in diagnosing ACL rupture.
- Conditions
- Knee Ligament; Laxity
- Being tested
- Side-to-side difference (reproducibility), Side-to-side difference (availability), Side-to-side difference (Accuracy)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Side-to-side difference (reproducibility)Diagnostic test
The experienced examiner performed tests on 20 healthy subjects
Side-to-side difference (availability)Diagnostic test
Two examiners performed the test on one healthy subject with both devices for ten consecutive days.
Side-to-side difference (Accuracy)Diagnostic test
200 ACL rupture and 200 healthy subjects were recruited as contrast to compare the accuracy of the devices in diagnosing ACL rupture.
| Study group | Role | What they receive |
|---|---|---|
| Examiner effect group | Two examiners performed the test on one healthy subject with both devices for ten consecutive days. We measured the AD of both knees and calculated the ADD of every test. We evaluated the contralateral-side effect by comparing the AD standard deviations of each knee with both devices, and compared the average ADD tested by different examiners with the same device, to estimate examiner effect. Receives: Diagnostic Test: Side-to-side difference (reproducibility) | |
| Method effect group | The experienced examiner performed tests on 20 healthy subjects using both devices. The means and standard deviations of both knees were calculated. We examined the difference in measurements using each device to determine the method effect. Receives: Diagnostic Test: Side-to-side difference (availability) | |
| Equipment effectiveness group | The experienced examiner performed tests on 200 ACL ruptureand 200 healthy subjects using each device. Effectiveness was analyzed using 1.5 mm and 3 mm threshold values in ACL tears. Receives: Diagnostic Test: Side-to-side difference (Accuracy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Side-to-side difference （SSD）
Side-to-side difference （SSD）at 134 N
Measured: within 3 months after ACL rupture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start30 Jun 2020
- Primary completion1 Jul 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Ligament; LaxityStudies 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
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beihang University
- Responsible party
- Sponsor
- Investigators
- yingfang ao, M.D., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956315
- Sponsor's protocol ID
- M2020263
- Status last verified
- Jul 2021
- First submitted
- 27 Jun 2021
- Last updated
- 9 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 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Stability of a New Automatic Knee Arthrometer in Diagnosing Anterior Cruciate Ligament Rupture
- ClinicalTrials.gov ID
- NCT04956315
- Acronym / sponsor ID
- M2020263
- Conditions
- Knee Ligament; Laxity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beihang University
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 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.
We introduced an automatic knee arthrometer (AKA) and aimed to evaluate the repeatability and effectiveness thereof in diagnosing ACL rupture compared with the KT-2000.
Detailed description
The AKA was compared to the KT-2000 at 134 N in this study, the anterior displacement and difference of both knees of every subject were measured. The first protocol was designed to evaluate examiner effect (level of experience) and contralateral-side effect (left or right knee) in a single healthy subject, ten times, on ten consecutive days. The second was to compare the stability in 20 healthy subjects, with a single experienced examiner. Third, we recruited 200 ACL rupture and 200 healthy subjects as contrast to compare the accuracy of the devices in diagnosing ACL rupture.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Examiner effect group | – | Diagnostic Test: Side-to-side difference (reproducibility)Two examiners performed the test on one healthy subject with both devices for ten consecutive days. We measured the AD of both knees and calculated the ADD of every test. We evaluated the contralateral-side effect by comparing the AD standard deviations of each knee with both devices, and compared the average ADD tested by different examiners with the same device, to estimate examiner effect. |
| Method effect group | – | Diagnostic Test: Side-to-side difference (availability)The experienced examiner performed tests on 20 healthy subjects using both devices. The means and standard deviations of both knees were calculated. We examined the difference in measurements using each device to determine the method effect. |
| Equipment effectiveness group | – | Diagnostic Test: Side-to-side difference (Accuracy)The experienced examiner performed tests on 200 ACL ruptureand 200 healthy subjects using each device. Effectiveness was analyzed using 1.5 mm and 3 mm threshold values in ACL tears. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- one healthy subject was tested with both devices for ten consecutive days to estimate examiner effect； 20 healthy subjects were tested with both devices to determine the method effect； 200 medicine students volunteered as healthy subjects; each with pain-free knees in the last three months, and without a history of knee injury； 200 patients with ACL rupture from our institution were also included.
Key inclusion criteria (1 listed)
- patients with ACL rupture from our institution were included. All patients were diagnosed by sports medicine specialists based on clinical manifestation, combined with imaging examinations, and hospitalized for further surgery.
Key exclusion criteria (1 listed)
- Patients aged <18 or >45 years, with combined multiple knee ligament injury combinations, and/or limited range of motion of the knee (unable to flex to 20-30°)
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 |
|---|---|---|
| Side-to-side difference (reproducibility)The experienced examiner performed tests on 20 healthy subjects | Diagnostic test | Examiner effect group |
| Side-to-side difference (availability)Two examiners performed the test on one healthy subject with both devices for ten consecutive days. | Diagnostic test | Method effect group |
| Side-to-side difference (Accuracy)200 ACL rupture and 200 healthy subjects were recruited as contrast to compare the accuracy of the devices in diagnosing ACL rupture. | Diagnostic test | Equipment effectiveness group |
Primary outcome
Side-to-side difference （SSD）
Time frame: within 3 months after ACL rupture
Side-to-side difference （SSD）at 134 N
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 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 Knee Ligament; Laxity, 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: finished, as of the sponsor's last update on 9 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Side-to-side difference （SSD） (time frame: within 3 months after ACL rupture). 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 9 Jul 2021; AzTrials last refreshed its copy on 6 Nov 2026.