Agreement Between Rolimeter and Lachmeter in Patients With ACL Injury
Agreement Between Two Methods for Assessing Knee Joint Laxity in Patients With ACL Injuries
The study is a quality assurance study, aiming to determine the agreement between two different measurement instruments for assessing knee joint laxity in patients with ACL injuries.
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Methods:
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Nanna Rolving, PhD
- Phone Number: 0045 21289188
- Email: Nanna.Rolving@rm.dk
Study Contact Backup
- Name: Torsten G Nielsen, MHSc
- Email: Torsten.Groenbech.Nielsen@auh.rm.dk
Study Locations
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Central Denmark Region
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Aarhus, Central Denmark Region, Denmark, 8200
- Recruiting
- Aarhus University Hospital
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Contact:
- Torsten G Nielsen, MHSc
- Email: Torsten.Groenbech.Nielsen@auh.rm.dk
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Contact:
- Nanna Rolving, PhD
- Phone Number: 0045 40321618
- Email: Nanna.Rolving@rm.dk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with ACL injury awaiting potential ACL-surgery
- Patients with previous ACL-surgery
Exclusion Criteria:
- Multiligament injury
- PCL injury
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with ACL injuries
Patients who have sustained an ACL injury, surgically or non-surgically treated.
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee joint laxity (millimeters)
Time Frame: For surgicaly treated patients: Between 1 year and up to 5 years post-surgery. For non-surgically treated patients: Up to 12 weeks after ACL injury.
|
Measurement of knee joint laxity using both a Rolimeter and a Lachmeter is conducted in connection with the patients' visit at the outpatient clinic.
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For surgicaly treated patients: Between 1 year and up to 5 years post-surgery. For non-surgically treated patients: Up to 12 weeks after ACL injury.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nanna Rolving, PhD, Aarhus University Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACL agreement study 2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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