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Clinical Trials/NCT06259773
NCT06259773
Recruiting
Not Applicable

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

Kaohsiung Veterans General Hospital.1 site in 1 country50 target enrollmentJanuary 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Injuries
Sponsor
Kaohsiung Veterans General Hospital.
Enrollment
50
Locations
1
Primary Endpoint
anterior/posterior tibial translation (mm)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yi Ping Wei

Staff doctor

Kaohsiung Veterans General Hospital.

Eligibility Criteria

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.

Outcomes

Primary Outcomes

anterior/posterior tibial translation (mm)

Time Frame: post-op 3 months, 6 months

by Stress X-ray

patient reported outcome measure

Time Frame: post-op 3 months, 6 months

Knee Outcome Survey-Activities of Daily Living Score (KOS-ADLS)

Study Sites (1)

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