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

NCT04956315 | Completed DMC

• 1 other identifier: M2020263
• Study Type: observational
• Target: 421
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Ligament; Laxity

Outcome Measures

Primary Outcomes (1)

• Side-to-side difference （SSD）

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

  within 3 months after ACL rupture

Study Arms (3)

Examiner effect group

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.

Diagnostic Test: Side-to-side difference (reproducibility)

Method effect group

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.

Diagnostic Test: Side-to-side difference (availability)

Equipment effectiveness group

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.

Diagnostic Test: Side-to-side difference (Accuracy)

Interventions

Side-to-side difference (reproducibility) DIAGNOSTIC_TEST

The experienced examiner performed tests on 20 healthy subjects

Examiner effect group

Side-to-side difference (availability) DIAGNOSTIC_TEST

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

Method effect group

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.

Equipment effectiveness group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

one healthy subject was tested with both devices for ten consecutive days to estimate examiner effect； 20 healthy subjects were tested with both devices to determine the method effect； 200 medicine students volunteered as healthy subjects; each with pain-free knees in the last three months, and without a history of knee injury； 200 patients with ACL rupture from our institution were also included.

You may qualify if:

• 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.

You may not qualify if:

• 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°)

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beihang University: collaborator

Study Sites (1)

Peking university third hospital

Beijing, Beijing Municipality, 100191, China

Location

Study Officials

• yingfang ao, M.D.

  Peking University Third Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2021
• First Posted: July 9, 2021
• Study Start: June 30, 2020
• Primary Completion: July 1, 2020
• Study Completion: December 31, 2020
• Last Updated: July 9, 2021

Record last verified: 2021-07

Locations

CN (1)