Skip to main content
OpenTrials
Completed

NCT Number: NCT04956315

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Knee Ligament; Laxity

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking university third hospital

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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°)

Treatment and study plan

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.

Primary outcomes

  1. Side-to-side difference （SSD）

    Time frame: within 3 months after ACL rupture

    Side-to-side difference （SSD）at 134 N

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Beihang University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 9, 2021
Registry last updated
Jul 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.