NCT04502134

Brief 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. Helps to understand the mechanism of tendon lesions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

1.4 years

First QC Date

July 22, 2020

Last Update Submit

November 20, 2020

Conditions

Rotator Cuff TearsRotator Cuff Tendinosis

Keywords

ultrasonographyrotator cuff tendinopathy

Outcome Measures

Primary Outcomes (1)

  • 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

    Month 2

Secondary Outcomes (1)

  • tendon-related transcription factors

    Month 1

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ultrasound diagnosis of damage to the shoulder rotator tendon, calcification, acromion bursitis or viscous shoulder capsule

You may qualify if:

  • age older than 20 y
  • shoulder pain more than 3 months and Visual Analogue Scale (VAS) \>4
  • shoulder tendon defect on ultrasound images

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100025, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

rotator cuff tendon fragments collecting from rotator cuff tendon repair surgery

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Central Study Contacts

Chao Yuan-Hung, PhD

CONTACT

0933121572yuanhungchao@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2020

First Posted

August 6, 2020

Study Start

November 30, 2019

Primary Completion

April 30, 2021

Study Completion

September 30, 2021

Last Updated

November 23, 2020

Record last verified: 2020-11

Locations

TW(1)