Ultrasonic Backscatter Imaging for ACL Reconstruction and Shoulder Diseases

NCT06361082 | Not Yet Recruiting DMC

• 1 other identifier: CORPG5N0061
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study explores ultrasonic scattering imaging technology in patients undergoing anterior cruciate ligament (ACL) reconstruction and those with shoulder musculoskeletal disorders. Ultrasonography, widely utilized for diagnosing musculoskeletal conditions, faces limitations due to factors like operator experience and equipment settings, often lacking in quantifiable disease metrics. Nakagami imaging, employing the backscattering statistical distribution model, offers a quantitative assessment method that minimizes subjective interpretation by extracting tissue properties through the interaction between ultrasound and tissue microstructure. The Nakagami model effectively describes tissue scattering statistics, enabling the identification and classification of tissue features based on specific scattering conditions. ACL reconstruction is commonly performed, with postoperative complications including joint stiffness and muscle strength decline, associated with changes in muscle quality and volume. Similarly, soft tissue injuries around the shoulder and ankle are prevalent in sports medicine, with ultrasound used to assess the severity of injuries to soft tissues such as the rotator cuff tendons/muscles and surrounding ligaments of the shoulder, as well as the medial and lateral ligament complexes of the ankle. Preliminary findings suggest that Nakagami imaging can differentiate layers within normal tendons, proposing its potential for visualizing and quantifying soft tissue lesions post-ultrasound, aiming for standardized diagnostic criteria. The results of this project could significantly improve the diagnostic efficacy of musculoskeletal ultrasound, facilitating earlier treatment and reducing the socio-economic impacts. Academically, it positions the investigating team as pioneers in the application of ultrasound inverse scattering imaging technology.

Conditions

ACL Injury; ACL Reconstruction

Keywords

Musculoskeletal ultrasound; ultrasound; Back-scattering; ACL reconstruction; ACL injury

Outcome Measures

Primary Outcomes (2)

• MRI of affected limb- Cross sectional area measured in squared cm of quadriceps muscles

  MRI of affected limb will be done, to measure quadriceps muscle cross sectional area in with unit of squared centimeters.

  0-6-12 weeks

• Ultrasound Nakagami back scattering analysis- Nakagami index

  Ultrasound of affected limb will be done, to calculate Nakagami. A back-scattering analysis algorithm will be applied to derive Nakagami index to give an innovative quantitative assessment of MSK ultrasound. This index as a pure numer index with no unut.

  0-6-12 weeks

Secondary Outcomes (5)

• Physical examination of limbs- Angles of Range of Motion of knee

  0-6-12 weeks

• MRI of affected limb- Quality of knee structures documented with descriptions for MR signals

  0-6-12 weeks

• Physical examination of limbs- Laxity of knee ligaments of subjects number with any positive knee physical findings

  0-6-12 weeks

• Ultrasound of affected limb- Cross sectional area measured in squared cm of quadriceps muscles

  0-6-12 weeks

• Ultrasound of affected limb- Quality of knee structures documented with descriptions for echogenicity

  0-6-12 weeks

Study Arms (2)

Non-ACLR Control Group

NO INTERVENTION

Control group arm. Subjects In this arm will receive MRI and ultrasound examination, without receiving any treatment.

ACLR Intervention Arm

EXPERIMENTAL

Intervention group arm. Subjects In this arm will receive MRI and ultrasound examination, before and after receiving ACL reconstruction.

Procedure: ACL reconstruction

Interventions

ACL reconstruction PROCEDURE

ACL reconstruction

ACLR Intervention Arm

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 20 and above
• Experimental group: Individuals with tendon, ligament, or nerve disorders around the shoulder joint
• Control group: Individuals with similar age and gender as the experimental group, confirmed by ultrasound and MRI to have no known diseases of the shoulder tendons, ligaments, or nerves

You may not qualify if:

• Individuals with a history of injury or disease in the area to be tested: such as fractures, tendon, ligament, or nerve disorders
• Vulnerable groups: such as pregnant women, children, individuals with mental illness, inmates, etc.
• Individuals who cannot communicate in Chinese
• Individuals with poor compliance or obvious mental status abnormalities, or for any reason unable to cooperate with completing clinical symptom interviews, physical examinations, ultrasound examinations, etc.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: April 11, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share