Agreement Between Rolimeter and Lachmeter in Patients With ACL Injury

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05614297
• Other study ID #: ACL agreement study 2022
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: November 2022
• Source: Region MidtJylland Denmark
• Contact: Nanna Rolving, PhD
• Phone: 0045 21289188
• Email: Nanna.Rolving[@]rm.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with ACL injury awaiting potential ACL-surgery

• Patients with previous ACL-surgery

Exclusion Criteria:

• Multiligament injury

• PCL injury

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Central Denmark Region

Sponsors (1)

Lead Sponsor	Collaborator
Region MidtJylland Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee joint laxity (millimeters)	Measurement of knee joint laxity using both a Rolimeter and a Lachmeter is conducted in connection with the patients' visit at the outpatient clinic.	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.