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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06259773
Enrollment
50
Registered
2024-02-14
Start date
2024-01-01
Completion date
2024-12-31
Last updated
2024-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries, Knee Arthritis, Knee Injuries, Knee Ligament Injury

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.

Interventions

DIAGNOSTIC_TESTknee 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.

Sponsors

Kaohsiung Veterans General Hospital.
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
anterior/posterior tibial translation (mm)post-op 3 months, 6 monthsby Stress X-ray
patient reported outcome measurepost-op 3 months, 6 monthsKnee Outcome Survey-Activities of Daily Living Score (KOS-ADLS)

Countries

Taiwan

Contacts

Primary ContactYi Ping Wei, Dr.
xgoznas22@gmail.com+886-0975581337

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026