Agreement Between Rolimeter and Lachmeter in Patients With ACL Injury
NCT ID: NCT05614297
Last Updated: 2022-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2022-09-01
2023-03-31
Brief Summary
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The study aims to include 60 patients with previous ACL injury, recruited in an outpatient clinic at Aarhus University Hospital from September 2022 to March 2023. For patients who consent to participate in the study, their knee joint laxity in both the injured and the non-injured knee is assessed using both a Rolimeter and a Lachmeter. Subsequently, the collected data are examined to determined the agreement between the two measurement instruments.
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Detailed Description
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In connection with their visit at either the orthopaedic or physiotherapy outpatient clinic, patients are invited to participate in the study. Patients consenting to participate will undergo knee joint laxity tests with both the Rolimeter and the Lachmeter, and in addition health-related and demographic data are collected.
The two tests are performed in random order for each patient, and the same physiotherapist conducts the two tests in each individual patient. The physiotherapist performing the two tests reads and notes the score on the first test, while a different physiotherapist, blinded to the score of the first test, reads and notes the score on the second test.
Agreement between the two scores are investigated using a Bland-Altman plot, with calculation of bias and upper and lower limits of agreements with 95% CIs. A priori, an acceptable difference between the two methods is set at 1 millimeter.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Patients with ACL injuries
Patients who have sustained an ACL injury, surgically or non-surgically treated.
Knee joint laxity test
Patients seen in an outpatient clinic in connection with an ACL injury or in connection with short or long-term follow-up after ACL surgery, will undergo a clinical assessment of their knee injury as part of standard care. This includes an assessment of knee joint laxity using both the Rolimeter and the Lachmeter, to allow for an assessment of agreement between the two methods.
Interventions
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Knee joint laxity test
Patients seen in an outpatient clinic in connection with an ACL injury or in connection with short or long-term follow-up after ACL surgery, will undergo a clinical assessment of their knee injury as part of standard care. This includes an assessment of knee joint laxity using both the Rolimeter and the Lachmeter, to allow for an assessment of agreement between the two methods.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with previous ACL-surgery
Exclusion Criteria
* PCL injury
18 Years
ALL
No
Sponsors
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Region MidtJylland Denmark
OTHER
Responsible Party
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Nanna Rolving
Senior researcher
Principal Investigators
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Nanna Rolving, PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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Aarhus University Hospital
Aarhus, Central Jutland, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ACL agreement study 2022
Identifier Type: -
Identifier Source: org_study_id
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