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Arthrometry and Clinical Tests for Diagnosing ACL Tears

NCT05416632 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2024-11-13

No results posted yet for this study

Summary

Anterior cruciate ligament (ACL) tears are diagnosed by combining the patient's history and physical examination but clinical tests (e.g., Lachman, anterior drawer, and pivot shift) are less accurate within the first three weeks of injury. The Lever sign is a clinical test that has shown to have comparable diagnostic accuracy regardless of the time since injury, but this test has not been subjected to a randomised clinical trial and diagnostic values may be overestimated.

Imaging modalities (e.g., MRI) are utilised when clinical diagnosis is not clear but are expensive and delay diagnosis. Hand-held arthrometry is an instrument that can be used in the clinical setting to provide an immediate, objective measure of ACL laxity, but this device has not been adequately validated.

The first aim of this study is to determine the accuracy of hand-held arthrometry for diagnosing ACL tears following acute injury. A reliable and valid device could reduce healthcare costs and expedite appropriate treatment, thereby improving the management of patients following knee injury. The second aim of this study is to determine the diagnostic accuracy of the Lever sign test using a more robust study design than previously employed in other studies.

Conditions

  • Anterior Cruciate Ligament Injuries
  • Anterior Cruciate Ligament Rupture
  • Anterior Cruciate Ligament Tear

Interventions

DIAGNOSTIC_TEST

Athrometer

Arthrometer

Sponsors & Collaborators

  • Liverpool University Hospitals NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Richard Norris · Liverpool University Hospitals NHS Foundation Trust

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2024-06-30
Completion
2024-07-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05416632 on ClinicalTrials.gov