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

NCT06259773 | Recruiting

• 1 other identifier: 23-CT12-26
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Injuries; Anterior Cruciate Ligament Injuries; Knee Ligament Injury; Knee Arthritis

Outcome Measures

Primary Outcomes (2)

• anterior/posterior tibial translation (mm)

  by Stress X-ray

  post-op 3 months, 6 months

• patient reported outcome measure

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

  post-op 3 months, 6 months

Interventions

knee stability test (DYNEELAX) DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Over 20 years old, suspected ligament damage caused by knee contusion

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Kaohsiung, 813, Taiwan

RECRUITING

MeSH Terms

Conditions

Knee Injuries; Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Yi Ping Wei, Dr.

  Kaohsiung veteran general hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Ping Wei, Dr.

CONTACT

+886-0975581337; xgoznas22@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff doctor

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 14, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)