The Roles of MRI, DYNEELAX and Stress X-ray in First-Line Diagnosis of Cruciate Ligament Injury

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

The Roles of MRI, DYNEELAX and Stress X-ray in First-Line Diagnosis of Cruciate Ligament Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06259773
• Other study ID #: 23-CT12-26
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Kaohsiung Veterans General Hospital.
• Contact: Yi Ping Wei, Dr.
• Phone: +886-0975581337
• Email: xgoznas22[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: Cruciate ligament tears are clinically diagnosed by detection of anterior or posterior tibial translation on physical examination; however, this manual method of assessment is imprecise, subjective, and not reproducible. Recently a new instrument, a stress radiographic device and knee stability test (DYNEELAX), were produced to objectively measure these displacements.

Objective: To assess new diagnostic methods, in the measurement of anterior/posterior tibial translation in cruciate ligament-deficient knee compared to the healthy knee.

Material and method: The MRI, stress radiographic device and knee stability test was applied to cruciate ligament-tear knees that were diagnosed by physical examination as having partial or complete cruciate ligament tears. Each knee was tested under a force 120 Newtons in a posterior to anterior direction to create anterior tibial translation at 20 degrees knee flexion. Side-to-side difference of anterior/posterior tibial translation (mm) was measured from radiographs. Measurement of rotation and translation by DYNEELAX was also recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria: Patients are diagnoed as ACL/PCL injury or suspect ligament sprain at Kaohsiung veteran general hospital.

Exclusion Criteria: Unable receing MRI exam, any op history of knee or fracture history on the impaired knee.

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Knee Arthritis
• Knee Injuries
• Knee Ligament Injury
• Wounds and Injuries

Intervention

Diagnostic Test:
• knee stability test (DYNEELAX)
Each knee was tested under a force 120 Newtons in a posterior to anterior direction to create anterior tibial translation at 20 degrees knee flexion. Side-to-side difference of anterior/posterior tibial translation (mm) was measured from radiographs. Measurement of rotation and translation by DYNEELAX was also recorded.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung	???

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anterior/posterior tibial translation (mm)	by Stress X-ray	post-op 3 months, 6 months
Primary	patient reported outcome measure	Knee Outcome Survey-Activities of Daily Living Score (KOS-ADLS)	post-op 3 months, 6 months