NCT05614297

Agreement Between Rolimeter and Lachmeter in Patients With ACL Injury

Agreement Between Two Methods for Assessing Knee Joint Laxity in Patients With ACL Injuries

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Region MidtJylland Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Anterior Cruciate Ligament Injuries
• Laxity of Ligament

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2022-11-14
• Last updated: 2022-11-14

Locations

1 site across 1 country: Denmark