Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361082
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-15
Brief Title:
Ultrasonic Backscatter Imaging for ACL Reconstruction and Shoulder Diseases
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
The Application of Ultrasonic Backscattering Imaging Technique to Patients With Anterior Cruciate Ligament Reconstruction and Shoulder Musculoskeletal Diseases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 tendonsmuscles 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
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 tendonsmuscles 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
Detailed Description:
This study aims to explore the application of ultrasonic scattering imaging technology in patients after anterior cruciate ligament ACL reconstruction and in patients with shoulder musculoskeletal disorders Ultrasonography is a convenient real-time non-invasive and portable imaging tool commonly used by clinicians for the diagnosis of musculoskeletal system disorders However the interpretation of ultrasound images can be affected by factors such as operator experience probe orientation machine type and parameter settings and most diseases cannot be quantified Nakagami imaging based on the backscattering statistical distribution model is a quantitative assessment method that can reduce subjective human judgment It extracts the basic physical properties of tissues based on the interaction between ultrasound and tissue microstructure The Nakagami distribution is an effective model for describing tissue inverse scattering envelope statistics which can identify tissue ultrasound image features and classify the examined tissue by comparing it with the specified envelope-related scattering conditions
ACL reconstruction surgery is a commonly performed procedure Postoperative issues often include joint stiffness loss of neuromuscular control muscle mass loss and muscle strength decline Changes in muscle quality and volume are associated with a decrease in thigh muscle strength Both MRI and ultrasound can be used to assess changes in muscle volume and quality Soft tissue injuries around the shoulder and ankle joints are common in the field of sports medicine Ultrasound is commonly used to assess the severity of injuries to soft tissues such as the rotator cuff tendonsmuscles and surrounding ligaments of the shoulder as well as the medial and lateral ligament complexes of the ankle Preliminary results of this study show that Nakagami scattering imaging can visually distinguish layers within normal tendons The investigative team hypothesizes that ultrasonic Nakagami scattering imaging can provide a method for visualizing and subsequent quantitative analysis of suspected soft tissue lesions in patients after ultrasound scanning with the goal of achieving standardized diagnostic parameters for soft tissue lesions
The results of this project may enhance the diagnostic efficacy of musculoskeletal ultrasound for use in musculoskeletal diseases If successful it could lead to earlier diagnosis and treatment for these patients reducing the socioeconomic losses associated with work and competition Academically it would establish the institution and team as world leaders in the application of ultrasound inverse scattering imaging technology
ACL reconstruction surgery is a commonly performed procedure Postoperative issues often include joint stiffness loss of neuromuscular control muscle mass loss and muscle strength decline Changes in muscle quality and volume are associated with a decrease in thigh muscle strength Both MRI and ultrasound can be used to assess changes in muscle volume and quality Soft tissue injuries around the shoulder and ankle joints are common in the field of sports medicine Ultrasound is commonly used to assess the severity of injuries to soft tissues such as the rotator cuff tendonsmuscles and surrounding ligaments of the shoulder as well as the medial and lateral ligament complexes of the ankle Preliminary results of this study show that Nakagami scattering imaging can visually distinguish layers within normal tendons The investigative team hypothesizes that ultrasonic Nakagami scattering imaging can provide a method for visualizing and subsequent quantitative analysis of suspected soft tissue lesions in patients after ultrasound scanning with the goal of achieving standardized diagnostic parameters for soft tissue lesions
The results of this project may enhance the diagnostic efficacy of musculoskeletal ultrasound for use in musculoskeletal diseases If successful it could lead to earlier diagnosis and treatment for these patients reducing the socioeconomic losses associated with work and competition Academically it would establish the institution and team as world leaders in the application of ultrasound inverse scattering imaging technology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None