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

Completed

• Conditions: Knee Ligament; Laxity
• Interventions: Diagnostic Test: Side-to-side difference (reproducibility); Diagnostic Test: Side-to-side difference (Accuracy); Diagnostic Test: Side-to-side difference (availability)

• Registration Number: NCT04956315
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Study Start: 2020-06-30
• Primary Completion: 2020-07-01
• Study Completion: 2020-12-31
• Study First Submitted: 2021-06-27
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-07
• Last Update Submitted: 2021-07-07
• Study First Posted: 2021-07-09
• Last Update Posted: 2021-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 421

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.

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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°)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Examiner effect group	Side-to-side difference (reproducibility)	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.
Equipment effectiveness group	Side-to-side difference (Accuracy)	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.
Method effect group	Side-to-side difference (availability)	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.

Primary Outcome Measures

Name	Time	Method
Side-to-side difference （SSD）	within 3 months after ACL rupture	Side-to-side difference （SSD）at 134 N

Trial Locations

Locations (1)

Peking university third hospital; 🇨🇳 Beijing, Beijing, China