Agreement Between Rolimeter and Lachmeter in Patients With ACL Injury

NCT05614297 | Unknown

• 1 other identifier: ACL agreement study 2022
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Injuries; Laxity of Ligament

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Patients with ACL injuries

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

Diagnostic Test: Knee joint laxity test

Interventions

Knee joint laxity test DIAGNOSTIC_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.

Also known as: Rolimeter, Lachmeter

Patients with ACL injuries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients are recruited consecutively from either the orthopaedic outpatient clinic (patients with ACL-injury) or the physiotherapy outpatient clinic (patients who have previously undergone ACL surgery) at Aarhus University Hospital.

You may qualify if:

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

You may not qualify if:

• Multiligament injury
• PCL injury

Sponsors & Collaborators

• Region MidtJylland Denmark: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Central Jutland, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Joint Instability

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Nanna Rolving, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nanna Rolving, PhD

CONTACT

0045 21289188; Nanna.Rolving@rm.dk

Torsten G Nielsen, MHSc

CONTACT

Torsten.Groenbech.Nielsen@auh.rm.dk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 14, 2022
• Study Start: September 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)