Last reviewed · How we verify

NCT05416632

Arthrometry and Clinical Tests for Diagnosing ACL Tears

Completed NA Last updated 13 November 2024
What this trial tests

NA trial testing Athrometer in Anterior Cruciate Ligament Injuries in 102 participants. Completed in 1 July 2024.

Timeline
6 February 2023
Primary endpoint
30 June 2024
1 July 2024

Quick facts

Lead sponsorLiverpool University Hospitals NHS Foundation Trust
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment102
Start date6 February 2023
Primary completion30 June 2024
Estimated completion1 July 2024
Sites2 locations across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Liverpool University Hospitals NHS Foundation Trust

Who can join

18 and older, any sex, with Anterior Cruciate Ligament Injuries or Anterior Cruciate Ligament Rupture. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Digital hand-held arthrometry is a reliable and accurate adjunct for diagnosing acute anterior cruciate ligament tears.
    Norris R, Price A, Maddox TW, Boswell W, et al · · 2025 · cited 3× · PMID 40303837 · DOI 10.1002/jeo2.70251
  2. Don't take their word for it: Investigating the diagnostic accuracy of history elements for anterior cruciate ligament tears.
    Price A, Gangadharan R, Simmons D, Boswell W, et al · · 2025 · PMID 41362477 · DOI 10.1002/jeo2.70586
  3. The Lever Sign Test Demonstrates Limited Clinical Utility for Diagnosing Full-Thickness Anterior Cruciate Ligament Tears After a Traumatic Knee Injury.
    Norris R, Price A, Byrne J, Pulford S, et al · · 2025 · PMID 40376390 · DOI 10.1177/23259671251334775

Verify or expand the search:

Other recruiting trials for Anterior Cruciate Ligament Injuries

Currently open trials in the same condition.

Other Liverpool University Hospitals NHS Foundation Trust trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05416632.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing