NCT04956315|CompletedDMC
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Sponsor study identifier
observational
421
1 country
1
Study Start
June 30, 2020
Actual (reported)Primary Completion
July 1, 2020
Actual (reported)Study Completion
December 31, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2020
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 30, 2020
Actual (reported)July 1, 2020
Actual (reported)December 31, 2020
Actual (reported)June 27, 2021
Actual (reported)July 9, 2021
Actual (reported)Side-to-side difference （SSD）
Side-to-side difference （SSD）at 134 N
within 3 months after ACL rupture
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.
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.
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.
The experienced examiner performed tests on 20 healthy subjects
Two examiners performed the test on one healthy subject with both devices for ten consecutive days.
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.
Peking university third hospital
Beijing, Beijing Municipality, 100191, China
yingfang ao, M.D.
Peking University Third Hospital
421 participants (actual enrollment reported by the registry).
First Submitted
June 27, 2021
First Posted
July 9, 2021
Study Start
June 30, 2020
Actual (reported)200 ACL rupture and 200 healthy subjects were recruited as contrast to compare the accuracy of the devices in diagnosing ACL rupture.
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Primary Completion
July 1, 2020
Actual (reported)Study Completion
December 31, 2020
Actual (reported)Last Updated
July 9, 2021
Record last verified: 2021-07
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Source: ClinicalTrials.gov.
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