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| Name | Class |
|---|---|
| Beihang University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Side-to-side difference (reproducibility) | Diagnostic Test | The experienced examiner performed tests on 20 healthy subjects |
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| Measure | Description | Time Frame |
|---|---|---|
| Side-to-side difference (SSD) | Side-to-side difference (SSD)at 134 N | within 3 months after ACL rupture |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| yingfang ao, M.D. | Peking University Third Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking university third hospital | Beijing | Beijing Municipality | 100191 | China |
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| Side-to-side difference (availability) | Diagnostic Test | Two examiners performed the test on one healthy subject with both devices for ten consecutive days. |
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| 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. |
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