Arthrometry and clinic tests for diagnosing ACL injury
Research type
Research Study
Full title
A prospective cross-sectional study to determine the reliability and validity of arthrometry and clinical tests for diagnosing anterior cruciate ligament (ACL) injury.
IRAS ID
305932
Contact name
Richard Norris
Contact email
Sponsor organisation
Liverpool University Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Summary of Research
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.
Summary of Results
In participants presenting within 21-days of knee injury, hand-held arthrometer measurements demonstrate excellent intrarater reliability and high validity estimates for evaluating the anterior cruciate ligament (ACL).The Lever sign test demonstrates limited clinical utility for diagnosing or excluding full-thickness ACL tears following traumatic knee injury.
REC name
HSC REC A
REC reference
22/NI/0147
Date of REC Opinion
4 Nov 2022
REC opinion
Further Information Favourable Opinion