CompletedNot Applicable

Arthrometry and Clinical Tests for Diagnosing ACL Tears

United Kingdom102 participantsStarted 2023-02-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. * No contraindications to arthrometer testing or MRI (see exclusion criteria). * 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. Exclusion Criteria: 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 mu…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Accuracy reliability and validity of hand-held arthrometry.

Timeframe: 104 weeks

Trial details

NCT IDNCT05416632

SponsorLiverpool University Hospitals NHS Foundation Trust

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Anterior Cruciate Ligament Injuries trials