NCT04997538

Brief 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.

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
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 22, 2023

Status Verified

January 1, 2023

Enrollment Period

6.8 years

First QC Date

June 25, 2021

Last Update Submit

June 20, 2023

Conditions

Keywords

geneexoncruciate ligamentpatellarmeniscus injury

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ACL injury surgery, patients after sports injury, knee joint shape abnormality, and patients with family genetic predisposition to sports related diseases

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with joint damage caused by external force.
  • The patient is accompanied by other injuries at the same time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine, Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Patella Fracture

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and Injuries

Study Officials

  • Lin Lin

    Peking University Third Hospital

    STUDY DIRECTOR

Central Study Contacts

Lin Lin

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2021

First Posted

August 9, 2021

Study Start

March 21, 2019

Primary Completion

December 30, 2025

Study Completion

December 31, 2025

Last Updated

June 22, 2023

Record last verified: 2023-01

Locations