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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04956315

Enrollment

421

Registered

2021-07-09

Start date

2020-06-30

Completion date

2020-12-31

Last updated

2021-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Ligament; Laxity

Brief 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.

Interventions

DIAGNOSTIC_TESTSide-to-side difference (reproducibility)

The experienced examiner performed tests on 20 healthy subjects

DIAGNOSTIC_TESTSide-to-side difference (availability)

Two examiners performed the test on one healthy subject with both devices for ten consecutive days.

DIAGNOSTIC_TESTSide-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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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°)

Design outcomes

Primary

Measure	Time frame	Description
Side-to-side difference （SSD）	within 3 months after ACL rupture	Side-to-side difference （SSD）at 134 N

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026