Arthrometry and Clinical Tests for Diagnosing ACL Tears

NCT05416632 | Completed

• 1 other identifier: SP0925
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Arthrometry; Lachmeter; Rolimeter

Outcome Measures

Primary Outcomes (1)

• Accuracy reliability and validity of hand-held arthrometry.

  Side to side differences in anterior tibial translation (measured in millimetres) using the arthrometer.

  104 weeks

Secondary Outcomes (1)

• To determine diagnostic accuracy of Lever sign test.

  104 weeks

Study Arms (1)

Arthrometer

EXPERIMENTAL

Diagnostic Test: Athrometer

Interventions

Athrometer DIAGNOSTIC_TEST

Arthrometer

Arthrometer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of knee injury (\<3 weeks since trauma for the validity study) with immediate swelling (\<2 hours) but no fracture on X-ray.
• Participant is willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.

You may not qualify if:

• Healthy contralateral knee; no current or previous history of significant knee injury, or a history of previous minor injury that is symptomatic at the time of recruitment. No previous knee surgery.
• The participant may not enter the study if they are unable to provide written consent to study participation, or there are contraindications to arthrometer testing or MRI, including the following:
• History of chronic disease or disorder that may put the participants at risk because of participation in the study including non-united fractures, severe peripheral vascular disease, aneurysms, recent (\<3 months) radiotherapy or chemotherapy, neurological disorders (e.g., Parkinson's disease), skin conditions at point of testing, severe osteoporosis, malignancy, rheumatoid arthritis.
• Patients with implanted surgical clips or other ferromagnetic material including shrapnel, metallic implants (excluding joint replacements \>6 weeks since surgery), non-MRI compatible prosthetic heart valves, surgery within 6 weeks, pregnancy, patients with compromised thermoregulatory systems.
• History of chronic musculoskeletal disease or disorder in either leg.

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

Study Sites (2)

Liverpool University Hospitals Nhs Foundation Trust

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

Aintree University Hospital NHS Foundation Trust

Liverpool, Merseyside, L9 7AL, United Kingdom

Location

Related Publications (10)

• Abbasi D, May MM, Wall EJ, Chan G, Parikh SN. MRI findings in adolescent patients with acute traumatic knee hemarthrosis. J Pediatr Orthop. 2012 Dec;32(8):760-4. doi: 10.1097/BPO.0b013e3182648d45.

  PMID: 23147616 BACKGROUND

• Olsson O, Isacsson A, Englund M, Frobell RB. Epidemiology of intra- and peri-articular structural injuries in traumatic knee joint hemarthrosis - data from 1145 consecutive knees with subacute MRI. Osteoarthritis Cartilage. 2016 Nov;24(11):1890-1897. doi: 10.1016/j.joca.2016.06.006. Epub 2016 Jun 29.

  PMID: 27374877 BACKGROUND

• Sarimo J, Rantanen J, Heikkila J, Helttula I, Hiltunen A, Orava S. Acute traumatic hemarthrosis of the knee. Is routine arthroscopic examination necessary? A study of 320 consecutive patients. Scand J Surg. 2002;91(4):361-4. doi: 10.1177/145749690209100410.

  PMID: 12558087 BACKGROUND

• Filbay SR, Grindem H. Evidence-based recommendations for the management of anterior cruciate ligament (ACL) rupture. Best Pract Res Clin Rheumatol. 2019 Feb;33(1):33-47. doi: 10.1016/j.berh.2019.01.018. Epub 2019 Feb 21.

  PMID: 31431274 BACKGROUND

• van Eck CF, van den Bekerom MP, Fu FH, Poolman RW, Kerkhoffs GM. Methods to diagnose acute anterior cruciate ligament rupture: a meta-analysis of physical examinations with and without anaesthesia. Knee Surg Sports Traumatol Arthrosc. 2013 Aug;21(8):1895-903. doi: 10.1007/s00167-012-2250-9. Epub 2012 Oct 20.

  PMID: 23085822 BACKGROUND

• Hatcher J, Hatcher A, Arbuthnot J, McNicholas M. An investigation to examine the inter-tester and intra-tester reliability of the Rolimeter knee tester, and its sensitivity in identifying knee joint laxity. J Orthop Res. 2005 Nov;23(6):1399-403. doi: 10.1016/j.orthres.2005.06.003.1100230623. Epub 2005 Aug 3.

  PMID: 16084050 BACKGROUND

• Decary S, Ouellet P, Vendittoli PA, Roy JS, Desmeules F. Diagnostic validity of physical examination tests for common knee disorders: An overview of systematic reviews and meta-analysis. Phys Ther Sport. 2017 Jan;23:143-155. doi: 10.1016/j.ptsp.2016.08.002. Epub 2016 Aug 5.

  PMID: 27693100 BACKGROUND

• Muellner T, Bugge W, Johansen S, Holtan C, Engebretsen L. Inter- and intratester comparison of the Rolimeter knee tester: effect of tester's experience and the examination technique. Knee Surg Sports Traumatol Arthrosc. 2001 Sep;9(5):302-6. doi: 10.1007/s001670100225.

  PMID: 11685363 BACKGROUND

• Sokal PA, Norris R, Maddox TW, Oldershaw RA. The diagnostic accuracy of clinical tests for anterior cruciate ligament tears are comparable but the Lachman test has been previously overestimated: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2022 Oct;30(10):3287-3303. doi: 10.1007/s00167-022-06898-4. Epub 2022 Feb 12.

  PMID: 35150292 BACKGROUND

• Norris R, Price A, Byrne J, Pulford S, van Melick N, Maddox TW, Boswell W, Kerin C, Oldershaw RA. The Lever Sign Test Demonstrates Limited Clinical Utility for Diagnosing Full-Thickness Anterior Cruciate Ligament Tears After a Traumatic Knee Injury. Orthop J Sports Med. 2025 May 14;13(5):23259671251334775. doi: 10.1177/23259671251334775. eCollection 2025 May.

  PMID: 40376390 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Richard Norris

  Liverpool University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinded
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: June 13, 2022
• Study Start: February 6, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 1, 2024
• Last Updated: November 13, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)