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RecruitingNCT05818904Updated Nov 8, 2023

Ultrasound Imaging of Fibrotic Tissue

An observational study in Arthrofibrosis of Knee and Arthrofibrosis of Shoulder, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-08.

Sponsored by Peking University Third Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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. 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

02

Conditions studied

  • Arthrofibrosis of Knee
  • Arthrofibrosis of Shoulder
03

In context

Lead sponsor

Peking University Third Hospital is the lead sponsor of 735 studies on the registry; 262 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Joint stiffness patients

Inclusion criteria

  1. Unilateral shoulder or knee joint stiffness and normal on the opposite side
  2. The course of the disease is longer than 3 months
  3. Good cognitive function, able to understand the content of this experiment, willing to cooperate with follow-up
  4. Over 18 years old, voluntarily participate in this study, and sign the informed consent

Exclusion criteria

Exclusion Criteria:

  1. Wound non-healing, joint dislocation or unstable fracture fixation, pseudarthrosis, joint purulent infection and other contraindications for joint range of motion examination
  2. 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • 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.

    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.

    Other: Physical Therapy

Interventions

  • OtherPhysical Therapy

    All arthrosis participants will be treated as the traditional methods using physical therapy.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3-month

  2. 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.

    Time frame: 3-month

Secondary outcomes

  1. 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.

    Time frame: 3-month

  2. 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.

    Time frame: 3-month

  3. 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.

    Time frame: 3-month

07

Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital
    Beijing, China
    • Buwen Yao · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05818904
Lead sponsor
Peking University Third Hospital
Responsible party
Zhou Mouwang (Professor, Peking University Third Hospital) — Principal investigator
First posted
Apr 19, 2023
Start date
May 1, 2023
Primary completion
Nov 30, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Nov 8, 2023

Study contacts

Buwen Yao, PhD
Contact
buwenyao@gmail.com
15600555851

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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