Agreement Between Rolimeter and Lachmeter in Patients With ACL Injury

Recruiting

• Conditions: Anterior Cruciate Ligament Injuries; Laxity of Ligament
• Interventions: Diagnostic Test: Knee joint laxity test

• Registration Number: NCT05614297
• Lead Sponsor: Region MidtJylland Denmark

Brief 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.

Study Timeline

• Study Start: 2022-09-01
• Status Verified: 2022-11
• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-10
• Last Update Submitted: 2022-11-10
• Study First Posted: 2022-11-14
• Last Update Posted: 2022-11-14
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with ACL injury awaiting potential ACL-surgery
• Patients with previous ACL-surgery

Exclusion Criteria

• Multiligament injury
• PCL injury

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with ACL injuries	Knee joint laxity test	Patients who have sustained an ACL injury, surgically or non-surgically treated.

Primary Outcome Measures

Name	Time	Method
Knee joint laxity (millimeters)	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.

Trial Locations

Locations (1)

Aarhus University Hospital; 🇩🇰 Aarhus, Central Denmark Region, Denmark