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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04457024
Other study ID # M2019143
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date April 1, 2020

Study information

Verified date June 2020
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To explore whether there is a difference in the rate of tendon tear after hyperlipemia in tennis elbow patients and those with normal blood lipids after closed treatment, which provides clues for further exploration of its mechanism. 1. Collect data from 108 cases of tennis elbow patients treated at the Institute of Sports Medicine, Peking University Third Hospital from January 2010 to December 2018 at the Institute of Sports Medicine, Peking University Third Hospital. Statistics included the sex, age, BMI, number of closures, total cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein. 2. Retrieve the MRI imaging data of the above-mentioned patients, and use the extensor tendon at the humerus to see if there is a tear as an observation indicator. Analyze the difference of tendon tear after closed treatment in patients with high blood fat and normal blood fat.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date April 1, 2020
Est. primary completion date February 20, 2020
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- All patients with tennis elbows in our hospital

Exclusion Criteria:

- none

Study Design


Related Conditions & MeSH terms


Intervention

Other:
classification statistics
Without any intervention

Locations

Country Name City State
China Peking Univerisity Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Use MRI to assess whether the tendon is torn One sports medicine surgeon and one musculoskeletal radiologists, being blinded to the patients' information, reviewed the elbow MRI independently. The common extensor tendon (CET) abnormalities were evaluated on axial and coronal fat-suppressed T2-weighted FSE image. Tendinosis group was defined as an increased signal intensity, but lower than the fluid signal on T2-weighted images and/ or an increased tendon thickness. Tendon tear group contain a partial thickness tear defined as a region with fluid-signal-intensity that extended partway across the tendon and a full thickness tear appeared as a gap of fluid-signal-intensity across the entire tendon substance. 3 months
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