ACL InjuryNCT06361082
Ultrasonic Backscatter Imaging for ACL Reconstruction and Shoulder Diseases
A study testing ACL reconstruction in people with ACL Injury and ACL Reconstruction, run by Chang Gung Memorial Hospital.
Trial summary
This study explores ultrasonic scattering imaging technology in patients undergoing anterior cruciate ligament (ACL) reconstruction and those with shoulder musculoskeletal disorders. Read more about this study
- Who is it for?
- Ages 20 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL Injury, ACL Reconstruction
- What is being tested?
- ACL reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: The Application of Ultrasonic Backscattering Imaging Technique to Patients With Anterior Cruciate Ligament Reconstruction and Shoulder Musculoskeletal Diseases
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.
Read the 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 tendons/muscles 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.
- Conditions
- ACL Injury, ACL Reconstruction
- Being tested
- ACL reconstruction
- Keywords
- Musculoskeletal ultrasound, ultrasound, Back-scattering, ACL reconstruction, ACL injury
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL reconstructionProcedure or surgery
ACL reconstruction
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: ACL reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 0-6-12 weeks
Secondary outcomes (5)
Physical examination of limbs- Angles of Range of Motion of knee
The ROM of knee from affected/control lower limb will be measured with Goniometer and documented in degrees.
Measured: 0-6-12 weeks
MRI of affected limb- Quality of knee structures documented with descriptions for MR signals
MRI of affected limb will be done, to assess muscle quality, and any associate ligamentous change (tendinopathy, tendinosis, etc).
Measured: 0-6-12 weeks
Physical examination of limbs- Laxity of knee ligaments of subjects number with any positive knee physical findings
Any laxity in anterior and posterior cruciate ligaments, medial and lateral collateral ligaments are also be tested and record in (+) or (-) signs.
Measured: 0-6-12 weeks
Ultrasound of affected limb- Cross sectional area measured in squared cm of quadriceps muscles
Ultrasound of affected limb will be done, to measure quadriceps muscle cross sectional area in with unit of squared centimeters.
Measured: 0-6-12 weeks
Ultrasound of affected limb- Quality of knee structures documented with descriptions for echogenicity
Ultrasound of affected limb will be done, to assess muscle quality, and any associate ligamentous change (tendinopathy, tendinosis, etc), in descriptions such as "hypoechoic change, heteroechoic change or eu-echoic appearance"
Measured: 0-6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study startApr 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361082
- Sponsor's protocol ID
- CORPG5N0061
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Ultrasonic Backscattering Imaging Technique to Patients With Anterior Cruciate Ligament Reconstruction and Shoulder Musculoskeletal Diseases
- ClinicalTrials.gov ID
- NCT06361082
- Acronym / sponsor ID
- CORPG5N0061
- Conditions
- ACL Injury, ACL Reconstruction
- Keywords
- Musculoskeletal ultrasound, ultrasound, Back-scattering, ACL reconstruction, ACL injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 tendons/muscles 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: ACL reconstructionIntervention group arm. Subjects In this arm will receive MRI and ultrasound examination, before and after receiving ACL reconstruction. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL reconstructionACL reconstruction | Procedure or surgery | ACLR Intervention Arm |
Primary outcome
MRI of affected limb- Cross sectional area measured in squared cm of quadriceps muscles
Time frame: 0-6-12 weeks
MRI of affected limb will be done, to measure quadriceps muscle cross sectional area in with unit of squared centimeters.
Ultrasound Nakagami back scattering analysis- Nakagami index
Time frame: 0-6-12 weeks
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.
5 secondary outcomes
Physical examination of limbs- Angles of Range of Motion of knee
Time frame: 0-6-12 weeks
MRI of affected limb- Quality of knee structures documented with descriptions for MR signals
Time frame: 0-6-12 weeks
Physical examination of limbs- Laxity of knee ligaments of subjects number with any positive knee physical findings
Time frame: 0-6-12 weeks
Ultrasound of affected limb- Cross sectional area measured in squared cm of quadriceps muscles
Time frame: 0-6-12 weeks
Ultrasound of affected limb- Quality of knee structures documented with descriptions for echogenicity
Time frame: 0-6-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Individual participant dataSharing planned: No
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Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ACL reconstruction in people with ACL Injury and ACL Reconstruction, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI of affected limb- Cross sectional area measured in squared cm of quadriceps muscles (time frame: 0-6-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.