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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04997538
Other study ID # IRB00006761-M2018245
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 21, 2019
Est. completion date December 31, 2025

Study information

Verified date January 2023
Source Peking University Third Hospital
Contact Jia-Kuo Yu
Phone 01082267392
Email yujiakuo@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Genomes of all sports medicine-related genes will be exome sequenced to find relevant gene mutations. To further study the molecular mechanisms and signaling pathways related to sports injury. To search for genetic risk factors of injury and put forward related scientific hypotheses. To demonstrate the importance of mutation or polymorphism of related genes in injury.


Recruitment information / eligibility

Status Recruiting
Enrollment 3000
Est. completion date December 31, 2025
Est. primary completion date December 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Patients with joint sports injuries. 2. Follow-up patients after sports injury. 3. Patients with genetic predisposition to sports injuries. 4. Patients with family genetic predisposition to exercise-related diseases and their relatives. Exclusion Criteria: 1. Patients with joint damage caused by external force. 2. The patient is accompanied by other injuries at the same time.

Study Design


Locations

Country Name City State
China Institute of Sports Medicine, Peking University 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 Magnetic resonance imaging (MRI) 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
Primary Magnetic resonance imaging (MRI) 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
Primary Radiographs 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
Primary Radiographs 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
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