Skip to main content
Clinical Trials/NCT04956315
NCT04956315
Completed
Not Applicable

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

Peking University Third Hospital1 site in 1 country421 target enrollmentJune 30, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Ligament; Laxity
Sponsor
Peking University Third Hospital
Enrollment
421
Locations
1
Primary Endpoint
Side-to-side difference (SSD)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 30, 2020
End Date
December 31, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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°)

Outcomes

Primary Outcomes

Side-to-side difference (SSD)

Time Frame: within 3 months after ACL rupture

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

Study Sites (1)

Loading locations...

Similar Trials