Anterior Cruciate Ligament InjuriesNCT05416632
Arthrometry and Clinical Tests for Diagnosing ACL Tears
A study testing Athrometer in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Liverpool University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- What is being tested?
- Athrometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 6 Feb 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Liverpool University Hospitals Nhs Foundation Trust
Liverpool, Merseyside, L7 8XP
Aintree University Hospital NHS Foundation Trust
Liverpool, Merseyside, L9 7AL
About this study
Official title: Diagnostic Accuracy of Hand Held Arthrometry and Clinical Tests for Diagnosing ACL Tears
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.
Read the detailed description
Approximately 40-50% of patients that present with immediate knee swelling (within 2 hours) following injury have an anterior cruciate ligament (ACL) tear. Potential consequences of an ACL tear include further knee injury, post-traumatic osteoarthritis, and reduced quality of life, therefore prompt, accurate diagnosis is important to expedite treatment and mitigate these risks. Within the first three weeks of injury, clinical tests have lower diagnostic accuracy due to pain, swelling and patient guarding making it difficult to assess the integrity of the ACL with confidence.
Magnetic resonance imaging (MRI) is often performed following knee trauma, as immediate swelling is associated with significant knee injury. However, MRI is costly and can result in a significant delay in diagnosis due to the time it takes for the scan to be performed, reported and acted on. Hand-held arthrometers are clinical instruments that provide immediate, objective measurement of knee laxity, which can then be used to inform decision making. Previous research indicates a side-to-side difference in laxity >3mm is diagnostic for an ACL rupture, with <3mm indicating a partial tear, but this device has not been adequately evaluated in acute presentations. In addition, the accuracy of ACL tests has not been adequately evaluated using robust methodology (randomised control trial) so diagnostic values may have been previously overestimated.
The objective of this study is to determine the diagnostic accuracy of hand-held arthrometry in acute presentations (<3 weeks) using MRI as the reference standard and a prospective design. In addition, a blinded, randomised control trial will be conducted using known ACL- injured and non-injured patients (based on MRI results), to provide robust diagnostic accuracy values for clinical ACL tests.
The hypothesis is that hand-held arthrometry will have superior diagnostic accuracy to the Lachman values reported in the systematic review and meta-analysis of Sokal et al (Sn: 0.89, Sp: 0.62, LR+ 1.79, LR- 0.33). A second hypothesis is that the Lever sign diagnostic accuracy values will be inferior to those reported in the the SR and MA of Sokal et al (Sn: 0.83, Sp: 0.91, LR+ 9.66, LR- 0.18). If arthrometry provides a reliable and valid measure of knee laxity, the device could save significant costs and delays to diagnosis associated with MRI.
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- Being tested
- Athrometer
- Keywords
- Arthrometry, Lachmeter, Rolimeter
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AthrometerDiagnostic test
Arthrometer
| Study group | Role | What they receive |
|---|---|---|
| Arthrometer | Experimental | Not described Receives: Diagnostic Test: Athrometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy reliability and validity of hand-held arthrometry.
Side to side differences in anterior tibial translation (measured in millimetres) using the arthrometer.
Measured: 104 weeks
Secondary outcomes (1)
To determine diagnostic accuracy of Lever sign test.
Dichotomous 'positive' or 'negative' ACL clinical test result.
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start6 Feb 2023
- Primary completion30 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Richard Norris, Principal investigator, Liverpool University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416632
- Sponsor's protocol ID
- SP0925
- Status last verified
- Mar 2023
- First submitted
- 25 May 2022
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23147616Olsson 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.
PubMed 27374877Sarimo 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.
PubMed 12558087Filbay 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.
PubMed 31431274van 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.
PubMed 23085822Hatcher 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.
PubMed 16084050Decary 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.
PubMed 27693100Muellner 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.
PubMed 11685363Sokal 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.
PubMed 35150292Norris 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.
PubMed 40376390
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Hand Held Arthrometry and Clinical Tests for Diagnosing ACL Tears
- ClinicalTrials.gov ID
- NCT05416632
- Acronym / sponsor ID
- SP0925
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- Keywords
- Arthrometry, Lachmeter, Rolimeter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately 40-50% of patients that present with immediate knee swelling (within 2 hours) following injury have an anterior cruciate ligament (ACL) tear. Potential consequences of an ACL tear include further knee injury, post-traumatic osteoarthritis, and reduced quality of life, therefore prompt, accurate diagnosis is important to expedite treatment and mitigate these risks. Within the first three weeks of injury, clinical tests have lower diagnostic accuracy due to pain, swelling and patient guarding making it difficult to assess the integrity of the ACL with confidence.
Magnetic resonance imaging (MRI) is often performed following knee trauma, as immediate swelling is associated with significant knee injury. However, MRI is costly and can result in a significant delay in diagnosis due to the time it takes for the scan to be performed, reported and acted on. Hand-held arthrometers are clinical instruments that provide immediate, objective measurement of knee laxity, which can then be used to inform decision making. Previous research indicates a side-to-side difference in laxity >3mm is diagnostic for an ACL rupture, with <3mm indicating a partial tear, but this device has not been adequately evaluated in acute presentations. In addition, the accuracy of ACL tests has not been adequately evaluated using robust methodology (randomised control trial) so diagnostic values may have been previously overestimated.
The objective of this study is to determine the diagnostic accuracy of hand-held arthrometry in acute presentations (<3 weeks) using MRI as the reference standard and a prospective design. In addition, a blinded, randomised control trial will be conducted using known ACL- injured and non-injured patients (based on MRI results), to provide robust diagnostic accuracy values for clinical ACL tests.
The hypothesis is that hand-held arthrometry will have superior diagnostic accuracy to the Lachman values reported in the systematic review and meta-analysis of Sokal et al (Sn: 0.89, Sp: 0.62, LR+ 1.79, LR- 0.33). A second hypothesis is that the Lever sign diagnostic accuracy values will be inferior to those reported in the the SR and MA of Sokal et al (Sn: 0.83, Sp: 0.91, LR+ 9.66, LR- 0.18). If arthrometry provides a reliable and valid measure of knee laxity, the device could save significant costs and delays to diagnosis associated with MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthrometer | Experimental | Diagnostic Test: Athrometer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AthrometerArthrometer | Diagnostic test | Arthrometer |
Primary outcome
Accuracy reliability and validity of hand-held arthrometry.
Time frame: 104 weeks
Side to side differences in anterior tibial translation (measured in millimetres) using the arthrometer.
1 secondary outcome
To determine diagnostic accuracy of Lever sign test.
Time frame: 104 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Background: PubMed 23147616Abbasi 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.
- Background: PubMed 27374877Olsson 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.
- Background: PubMed 12558087Sarimo 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.
- Background: PubMed 31431274Filbay 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.
- Background: PubMed 23085822van 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.
- Background: PubMed 16084050Hatcher 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.
- Background: PubMed 27693100Decary 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.
- Background: PubMed 11685363Muellner 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.
- Background: PubMed 35150292Sokal 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.
- Derived from this study: PubMed 40376390Norris 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Norris principal investigator
Liverpool University Hospitals NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Athrometer in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by Liverpool University Hospitals NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy reliability and validity of hand-held arthrometry. (time frame: 104 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05416632, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.