Accuracy and Stability of a New Automatic Knee Arthrometer in Diagnosing ACL Rupture
NCT ID: NCT04956315
Last Updated: 2021-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
421 participants
OBSERVATIONAL
2020-06-30
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Side-to-side difference (reproducibility)
The experienced examiner performed tests on 20 healthy subjects
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.
Side-to-side difference (availability)
Two examiners performed the test on one healthy subject with both devices for ten consecutive days.
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.
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.
Interventions
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Side-to-side difference (reproducibility)
The experienced examiner performed tests on 20 healthy subjects
Side-to-side difference (availability)
Two examiners performed the test on one healthy subject with both devices for ten consecutive days.
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
ALL
Yes
Sponsors
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Beihang University
OTHER
Peking University Third Hospital
OTHER
Responsible Party
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Principal Investigators
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yingfang ao, M.D.
Role: STUDY_CHAIR
Peking University Third Hospital
Locations
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Peking university third hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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M2020263
Identifier Type: -
Identifier Source: org_study_id
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