Agreement Between Rolimeter and Lachmeter in Patients With ACL Injury

Sponsor
Region MidtJylland Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT05614297
Collaborator
(none)
60
1
6.9
8.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Knee joint laxity test

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Agreement Between Two Methods for Assessing Knee Joint Laxity in Patients With ACL Injuries
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Patients with ACL injuries

Patients who have sustained an ACL injury, surgically or non-surgically treated.

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.
Other Names:
  • Rolimeter
  • Lachmeter
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with ACL injury awaiting potential ACL-surgery

    • Patients with previous ACL-surgery

    Exclusion Criteria:
    • Multiligament injury

    • PCL injury

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aarhus University Hospital Aarhus Central Denmark Region Denmark 8200

    Sponsors and Collaborators

    • Region MidtJylland Denmark

    Investigators

    • Principal Investigator: Nanna Rolving, PhD, Aarhus University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nanna Rolving, Senior researcher, Aarhus University Hospital
    ClinicalTrials.gov Identifier:
    NCT05614297
    Other Study ID Numbers:
    • ACL agreement study 2022
    First Posted:
    Nov 14, 2022
    Last Update Posted:
    Nov 14, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 14, 2022