Arthrofibrosis of KneeNCT05818904
Ultrasound Imaging of Fibrotic Tissue
An observational study of Arthrofibrosis of Knee and Arthrofibrosis of Shoulder, run by Peking University Third Hospital at 1 site in China.
Trial summary
This project intends to collect the ultrasonic spectrum information of shoulder and knee joint fibrotic tissue, and use machine learning to study the mechanism of fibrosis tissue ultrasound imaging, and then build a model and finally establish the relationship between joint stiffness and fibrosis formation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthrofibrosis of Knee, Arthrofibrosis of Shoulder
- What is being tested?
- Physical Therapy
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2023to 31 Dec 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Joint stiffness patients
Who may be able to join
- Unilateral shoulder or knee joint stiffness and normal on the opposite side
- The course of the disease is longer than 3 months
- Good cognitive function, able to understand the content of this experiment, willing to cooperate with follow-up
- Over 18 years old, voluntarily participate in this study, and sign the informed consent
Who cannot join
- Wound non-healing, joint dislocation or unstable fracture fixation, pseudarthrosis, joint purulent infection and other contraindications for joint range of motion examination
- There are skin lesions, wounds or allergies to the coupling agent on the joint surface and other conditions that cannot be used for ultrasound examination
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Buwen Yao
About this study
Official title: Ultrasound Imaging of Fibrotic Tissue Using Machine Learning
This project intends to collect the ultrasonic spectrum information of shoulder and knee joint fibrotic tissue, and use machine learning to study the mechanism of fibrosis tissue ultrasound imaging, and then build a model and finally establish the relationship between joint stiffness and fibrosis formation. In this study, the broadband ultrasound imaging method for joint fibrosis has the potential to create a method for ultrasonic localization, staining and evaluation of joint fibrosis, laying the foundation for the research of new conservative treatment methods and surgical positioning for fibrosis, and for reducing the occurrence of joint fibrosis rate, improve joint function of patients, and return to family and society earlier and better
- Conditions
- Arthrofibrosis of Knee, Arthrofibrosis of Shoulder
- Being tested
- Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
All arthrosis participants will be treated as the traditional methods using physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy group is recruited. They would not receive any intervention. The ultrasound imaging data will be collected to serve as the comparison for no fibrosis joint. | |
| Arthrosis of knee | People with arthrosis of the knee joint will be treated using the traditional intervention, which includes physical therapy. The ultrasound imaging will be collected before the intervention and at 3-month. The imaging data will be used to build a imaging model using the machine learning method. Receives: Other: Physical Therapy | |
| arthrosis of shoulder | People with arthrosis of the shoulder joint will be treated using the traditional intervention, which includes physical therapy. The ultrasound imaging will be collected before the intervention and at 3-month. The imaging data will be used to build a imaging model using the machine learning method. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS score
The KOOS (Knee injury and Osteoarthritis Outcome Score) survey is a health questionnaire used to assess the impact of knee injury or osteoarthritis on patients. It has 42 questions covering 5 domains and is rated on a 5-point Likert scale. The scale ranges from 0 to 100, with higher scores indicating better outcomes. The KOOS survey is a reliable and valid tool used in research and clinical practice to assess treatment effectiveness and track symptom changes over time.
Measured: 3-month
CM score
The Constant-Murley survey is a health questionnaire used to evaluate shoulder function and pain. It consists of four domains: pain, activities of daily living, range of motion, and strength. The scale ranges from 0 to 100, with higher scores indicating better outcomes. The Constant-Murley survey is a reliable and valid tool used in research and clinical practice to assess treatment effectiveness and track symptom changes over time.
Measured: 3-month
Secondary outcomes (3)
SF-36
The SF-36 (36-Item Short Form Survey) is a health questionnaire used to measure general health and well-being. It consists of 36 questions that evaluate eight domains, including physical functioning, role limitations, pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. The scale ranges from 0 to 100, with higher scores indicating better outcomes. The SF-36 survey is a widely used and reliable tool used in research and clinical practice to assess health status and well-being.
Measured: 3-month
WOMAC
The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) survey is a health questionnaire used to evaluate the severity of osteoarthritis in the knee and hip joints. It consists of 24 questions that evaluate three domains, including pain, stiffness, and physical function. The scale ranges from 0 to 96, with higher scores indicating worse outcomes. The WOMAC survey is a reliable and valid tool used in research and clinical practice to assess treatment effectiveness and track symptom changes over time.
Measured: 3-month
HSS-KS
The HSS (Hospital for Special Surgery) survey is a health questionnaire used to assess patient outcomes after total hip or knee replacement surgery. It consists of 40 questions that evaluate patient pain, function, and satisfaction with the surgery. The scale ranges from 0 to 100, with higher scores indicating better outcomes. The HSS survey is a reliable and valid tool used in research and clinical practice to assess treatment effectiveness and track patient satisfaction and function over time.
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start1 May 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthrofibrosis of KneeStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Mouwang, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818904
- Sponsor's protocol ID
- M2022793
- Status last verified
- Nov 2023
- First submitted
- 8 Mar 2023
- Last updated
- 8 Nov 2023
- 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 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Imaging of Fibrotic Tissue Using Machine Learning
- ClinicalTrials.gov ID
- NCT05818904
- Acronym / sponsor ID
- M2022793
- Conditions
- Arthrofibrosis of Knee, Arthrofibrosis of Shoulder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Apr 2023 (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 project intends to collect the ultrasonic spectrum information of shoulder and knee joint fibrotic tissue, and use machine learning to study the mechanism of fibrosis tissue ultrasound imaging, and then build a model and finally establish the relationship between joint stiffness and fibrosis formation. In this study, the broadband ultrasound imaging method for joint fibrosis has the potential to create a method for ultrasonic localization, staining and evaluation of joint fibrosis, laying the foundation for the research of new conservative treatment methods and surgical positioning for fibrosis, and for reducing the occurrence of joint fibrosis rate, improve joint function of patients, and return to family and society earlier and better
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –Healthy group is recruited. They would not receive any intervention. The ultrasound imaging data will be collected to serve as the comparison for no fibrosis joint. |
| Arthrosis of knee | – | Other: Physical TherapyPeople with arthrosis of the knee joint will be treated using the traditional intervention, which includes physical therapy. The ultrasound imaging will be collected before the intervention and at 3-month. The imaging data will be used to build a imaging model using the machine learning method. |
| arthrosis of shoulder | – | Other: Physical TherapyPeople with arthrosis of the shoulder joint will be treated using the traditional intervention, which includes physical therapy. The ultrasound imaging will be collected before the intervention and at 3-month. The imaging data will be used to build a imaging model using the machine learning method. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Joint stiffness patients
Key inclusion criteria (4 listed)
- Unilateral shoulder or knee joint stiffness and normal on the opposite side
- The course of the disease is longer than 3 months
- Good cognitive function, able to understand the content of this experiment, willing to cooperate with follow-up
- Over 18 years old, voluntarily participate in this study, and sign the informed consent
Key exclusion criteria (2 listed)
- Wound non-healing, joint dislocation or unstable fracture fixation, pseudarthrosis, joint purulent infection and other contraindications for joint range of motion examination
- There are skin lesions, wounds or allergies to the coupling agent on the joint surface and other conditions that cannot be used for ultrasound examination
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 |
|---|---|---|
| Physical TherapyAll arthrosis participants will be treated as the traditional methods using physical therapy. | Other | Arthrosis of knee, arthrosis of shoulder |
Primary outcome
KOOS score
Time frame: 3-month
The KOOS (Knee injury and Osteoarthritis Outcome Score) survey is a health questionnaire used to assess the impact of knee injury or osteoarthritis on patients. It has 42 questions covering 5 domains and is rated on a 5-point Likert scale. The scale ranges from 0 to 100, with higher scores indicating better outcomes. The KOOS survey is a reliable and valid tool used in research and clinical practice to assess treatment effectiveness and track symptom changes over time.
CM score
Time frame: 3-month
The Constant-Murley survey is a health questionnaire used to evaluate shoulder function and pain. It consists of four domains: pain, activities of daily living, range of motion, and strength. The scale ranges from 0 to 100, with higher scores indicating better outcomes. The Constant-Murley survey is a reliable and valid tool used in research and clinical practice to assess treatment effectiveness and track symptom changes over time.
3 secondary outcomes
SF-36
Time frame: 3-month
WOMAC
Time frame: 3-month
HSS-KS
Time frame: 3-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Arthrofibrosis of Knee
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Active, not recruitingPhase 4
Intravenous (IV) Hydrocortisone for TKA (Total Knee Arthroplasty)
Pain, Arthrofibrosis
Recruiting
Stiffness and Low Dose Irradiation RCT
Arthrofibrosis of Knee
Not yet recruitingPhase 4
Study to Use Oral Losartan to Decrease the Risk of Postoperative Scarring Following (ACL) Reconstruction
ACL Injury, ACL Reconstruction
RecruitingPhase 1/2
Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan
Knee Arthroplasty, Total
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthrofibrosis of Knee and Arthrofibrosis of Shoulder, run by Peking University Third Hospital at 1 site in China.
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 4 inclusion and 2 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 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Buwen Yao, PhD (15600555851, buwenyao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS score (time frame: 3-month). 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 8 Nov 2023.