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

Recruiting

• Conditions: Knee Injuries; Anterior Cruciate Ligament Injuries; Knee Ligament Injury; Knee Arthritis

• Registration Number: NCT06259773
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Study First Posted: 2024-02-14
• Last Update Posted: 2024-02-14
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
anterior/posterior tibial translation (mm)	post-op 3 months, 6 months	by Stress X-ray
patient reported outcome measure	post-op 3 months, 6 months	Knee Outcome Survey-Activities of Daily Living Score (KOS-ADLS)

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, 高雄市, Taiwan