Rotator Cuff TearsNCT04502134
Association Between Tendon-related Transcription Factor and Ultrasound Images and Shoulder Function
An observational study of Rotator Cuff Tears and Rotator Cuff Tendinosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this project is to extract effusions and damaged tendons during tendon repair therapy in patients with tendon tears. Then, we would analyze tendon-related transcription factors from histology and cytology, and compare changes in tendon with ultrasound images. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Tendinosis
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Nov 2019to 30 Sep 2021
- How long will I take part?
- 2 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ultrasound diagnosis of damage to the shoulder rotator tendon, calcification, acromion bursitis or viscous shoulder capsule
Who may be able to join
- age older than 20 y
- shoulder pain more than 3 months and Visual Analogue Scale (VAS) >4
- shoulder tendon defect on ultrasound images
Who cannot join
- diagnosis of cervical radiculopathy or other central or peripheral neuropathy
- rheumatoid arthritis or other autoimmune diseases
- have received any shoulder joint injection within three months
- tumor or systematic inflammation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100025
Chao Yuan-Hung, PhD, 0933121572
About this study
The purpose of this project is to extract effusions and damaged tendons during tendon repair therapy in patients with tendon tears. Then, we would analyze tendon-related transcription factors from histology and cytology, and compare changes in tendon with ultrasound images. Helps to understand the mechanism of tendon lesions.
Read the detailed description
According to past studies, it is often observed that changes in extracellular matrix, growth factors, and cytokines in degenerative tendons, indicating that the tendon is constantly changing. This change will in turn produce a change in the morphology of the tendon tissue in the ultrasound image. However, there have been few studies in the past literature on the correlation between constant changes in tendon-specific transcription factors and characterization on clinical ultrasound images. Therefore, the purpose of this project is to extract the effusion and damaged tendon while performing tendon repair therapy in patients with tendon tears, and to analyze the tendon-related transcription factors from histology and cytology to understand the changes in tendon homeostasis. At the same time, the interpretation of clinical ultrasound images was combined to establish the relationship between the biochemical factors of the cell tissues of chronic tendon lesions and the clinical ultrasound image. This study will help us to understand the mechanism of chronic tendinopathy.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Tendinosis
- Keywords
- ultrasonography, rotator cuff tendinopathy
- Medical subject headings
- Rotator Cuff Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between ultrasound image and tendon tissue sectioning and staining
comparing the image of ultrasound and tendon tissue sectioning and staining to understand the tendon changing in micro stage while the defect could be singed on the ultrasound image
Measured: Month 2
Secondary outcomes (1)
tendon-related transcription factors
Tendon tissue sectioning and staining Immunohistochemical staining DNA microarray Tendon cell culture Flow cytometry Real-time quantitative reverse transcription polymerase chain reaction RNA-interference-mediated gene silencing
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start30 Nov 2019
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502134
- Sponsor's protocol ID
- 201910004RIND
- Status last verified
- Nov 2020
- First submitted
- 22 Jul 2020
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Tendon-related Transcription Factor and Ultrasound Images and Shoulder Function
- ClinicalTrials.gov ID
- NCT04502134
- Acronym / sponsor ID
- 201910004RIND
- Conditions
- Rotator Cuff Tears, Rotator Cuff Tendinosis
- Keywords
- ultrasonography, rotator cuff tendinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 30 Nov 2019 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 6 Aug 2020 (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.
The purpose of this project is to extract effusions and damaged tendons during tendon repair therapy in patients with tendon tears. Then, we would analyze tendon-related transcription factors from histology and cytology, and compare changes in tendon with ultrasound images. Helps to understand the mechanism of tendon lesions.
Detailed description
According to past studies, it is often observed that changes in extracellular matrix, growth factors, and cytokines in degenerative tendons, indicating that the tendon is constantly changing. This change will in turn produce a change in the morphology of the tendon tissue in the ultrasound image. However, there have been few studies in the past literature on the correlation between constant changes in tendon-specific transcription factors and characterization on clinical ultrasound images. Therefore, the purpose of this project is to extract the effusion and damaged tendon while performing tendon repair therapy in patients with tendon tears, and to analyze the tendon-related transcription factors from histology and cytology to understand the changes in tendon homeostasis. At the same time, the interpretation of clinical ultrasound images was combined to establish the relationship between the biochemical factors of the cell tissues of chronic tendon lesions and the clinical ultrasound image. This study will help us to understand the mechanism of chronic tendinopathy.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ultrasound diagnosis of damage to the shoulder rotator tendon, calcification, acromion bursitis or viscous shoulder capsule
Key inclusion criteria (3 listed)
- age older than 20 y
- shoulder pain more than 3 months and Visual Analogue Scale (VAS) >4
- shoulder tendon defect on ultrasound images
Key exclusion criteria (4 listed)
- diagnosis of cervical radiculopathy or other central or peripheral neuropathy
- rheumatoid arthritis or other autoimmune diseases
- have received any shoulder joint injection within three months
- tumor or systematic inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation between ultrasound image and tendon tissue sectioning and staining
Time frame: Month 2
comparing the image of ultrasound and tendon tissue sectioning and staining to understand the tendon changing in micro stage while the defect could be singed on the ultrasound image
1 secondary outcome
tendon-related transcription factors
Time frame: Month 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
Related trials for Rotator Cuff Tears
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruiting
Voll Non-Degradable Shoulder Spacer FIH Study
Massive Rotator Cuff Tears, Massive Rotator Cuff Tear
Active, not recruitingPhase 2
Influence of an Anti-osteoporotic Drug on Healing After Surgical Repair of Chronic Rotator Cuff Lesions of the Shoulder
Orthopedics, Traumatology
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
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 Rotator Cuff Tears and Rotator Cuff Tendinosis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 23 Nov 2020. 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 Taiwan. 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 Chao Yuan-Hung, PhD (0933121572, yuanhungchao@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between ultrasound image and tendon tissue sectioning and staining (time frame: Month 2). 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 23 Nov 2020.