NCT04956315

Accuracy and Stability of a New Automatic Knee Arthrometer in Diagnosing ACL Rupture

Accuracy and Stability of a New Automatic Knee Arthrometer in Diagnosing Anterior Cruciate Ligament Rupture

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 421 (actual)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Side-to-side difference (reproducibility)	The experienced examiner performed tests on 20 healthy subjects
DIAGNOSTIC_TEST	Side-to-side difference (availability)	Two examiners performed the test on one healthy subject with both devices for ten consecutive days.
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2020-06-30
• Primary completion: 2020-07-01
• Completion: 2020-12-31
• First posted: 2021-07-09
• Last updated: 2021-07-09

Locations

1 site across 1 country: China