- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04997629
Gene Biobank of Sports Injuries
August 6, 2021 updated by: Peking University Third Hospital
Preserve Biological Samples and Gene Extracts of All Sports Medicine-related Diseases. To Study Related Gene Mutation Sites and Regulation. To Study Related Molecular Mechanisms and Signaling Pathways. A Storage Platform for Sports Medicine-related Diseases Research Sample Database Has Been Established.
Preserve biological samples and gene extracts of all sports medicine-related diseases.
To study related gene mutation sites and regulation.
To study related molecular mechanisms and signaling pathways.
A storage platform for sports medicine-related diseases research sample database has been established.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
10000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jia-Kuo Yu
- Phone Number: 01082267392
- Email: yujiakuo@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100191
- Recruiting
- Institute of Sports Medicine, Peking University Third Hospital
-
Contact:
- Ai-Bing Huang, PhD
- Phone Number: 8615650715003
- Email: hab165@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients related to sports injuries
Description
Inclusion Criteria:
- Patients with joint sports injuries.
- Follow-up patients after sports injury.
- Patients with genetic predisposition to sports injuries.
- Patients with family genetic predisposition to exercise-related diseases and their relatives.
Exclusion Criteria:
- Patients with joint damage caused by external force.
- The patient is accompanied by other injuries at the same time.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Magnetic resonance imaging (MRI)
Time Frame: Before the operation
|
All MRI scans were obtained with a 3.0-T MRI scanner (Magnetom Trio with TIM system, Siemens Healthcare).
Five routine MRI sequences with a section thickness of 4 mm were obtained in all patients.
Preoperative and postoperative evaluations of the articular cartilage of the transplanted compartment were performed with the Yulish score41 (grade 0 = normal; grade 1 = normal contour 6 abnormal signal; grade 2 = superficial fraying, erosion, or ulceration of <50%; grade 3 = partial-thickness defect of >50% but <100%; grade 4 = full-thickness cartilage loss).
The signal of the meniscus allograft in the coronal plane of the T2-weighted fast spin echo sequence was graded on a scale of 0 to 3.
|
Before the operation
|
Magnetic resonance imaging (MRI)
Time Frame: an average of 1 year
|
All MRI scans were obtained with a 3.0-T MRI scanner (Magnetom Trio with TIM system, Siemens Healthcare).
Five routine MRI sequences with a section thickness of 4 mm were obtained in all patients.
Preoperative and postoperative evaluations of the articular cartilage of the transplanted compartment were performed with the Yulish score41 (grade 0 = normal; grade 1 = normal contour 6 abnormal signal; grade 2 = superficial fraying, erosion, or ulceration of <50%; grade 3 = partial-thickness defect of >50% but <100%; grade 4 = full-thickness cartilage loss).
The signal of the meniscus allograft in the coronal plane of the T2-weighted fast spin echo sequence was graded on a scale of 0 to 3.
|
an average of 1 year
|
Radiographs
Time Frame: Before the operation
|
All patients also obtained 45° flexion weightbearing AP radiographs of both the ipsilateral and contralateral sides at final follow-up.
The radiograph of the total length of the lower limbs was used to evaluate alignment.
In the AP plain radiographs, the shortest distance between the femoral condyle and tibial plateau of the transplanted side was measured and designated as the joint space height.
The difference between the ipsilateral and contralateral sides was calculated to identify joint space narrowing.
In addition, Kellgren-Lawrence (K-L) grading was used to assess the osteoarthritic status of the knee.
|
Before the operation
|
Radiographs
Time Frame: an average of 1 year
|
All patients also obtained 45° flexion weightbearing AP radiographs of both the ipsilateral and contralateral sides at final follow-up.
The radiograph of the total length of the lower limbs was used to evaluate alignment.
In the AP plain radiographs, the shortest distance between the femoral condyle and tibial plateau of the transplanted side was measured and designated as the joint space height.
The difference between the ipsilateral and contralateral sides was calculated to identify joint space narrowing.
In addition, Kellgren-Lawrence (K-L) grading was used to assess the osteoarthritic status of the knee.
|
an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 21, 2019
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
June 27, 2021
First Submitted That Met QC Criteria
August 6, 2021
First Posted (Actual)
August 9, 2021
Study Record Updates
Last Update Posted (Actual)
August 9, 2021
Last Update Submitted That Met QC Criteria
August 6, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00006761-M2019063
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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