The Mechanism for the Effects of Joint Biomechanical Properties on Medial Cartilage of Tibiofemoral Joint Degeneration
1 other identifier
observational
60
0 countries
N/A
Brief Summary
Explore The Mechanism for the Effects of Joint Biomechanical Properties on Medial Cartilage of Tibiofemoral Joint Degeneration
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2021
Typical duration for all trials
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
First Submitted
Initial submission to the registry
July 2, 2021
CompletedFirst Posted
Study publicly available on registry
July 20, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedJuly 20, 2021
July 1, 2021
5 months
July 2, 2021
July 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (24)
knee T1 rho value
knee T1 rho value by functional MRI
On the day of enrollment.
knee T1 rho value
knee T1 rho value by functional MRI
At 6 months post operation.
knee T1 rho value
knee T1 rho value by functional MRI
At 12 months post operation.
knee T1 rho value
knee T1 rho value by functional MRI
At 2 years post operation.
knee T2 value
knee T1 rho value by functional MRI
On the day of enrollment.
knee T2 value
knee T1 rho value by functional MRI
At 6 months post operation.
knee T2 value
knee T1 rho value by functional MRI
At 12 months post operation.
knee T2 value
knee T1 rho value by functional MRI
At 2 years post operation.
knee extension angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
On the day of enrollment.
knee extension angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
At 6 months post operation.
knee extension angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
At 12 months post operation.
knee extension angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
At 2 years post operation.
knee moments
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
On the day of enrollment.
knee moments
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
At 6 months post operation.
knee moments
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
At 12 months post operation.
knee moments
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
At 2 years post operation.
ground reaction force
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
On the day of enrollment.
ground reaction force
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
At 6 months post operation.
ground reaction force
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
At 12 months post operation.
ground reaction force
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
At 2 years post operation.
knee rotation angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
On the day of enrollment.
knee rotation angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
At 6 months post operation.
knee rotation angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
At 12 months post operation.
knee rotation angles
Three-dimensional gait analysis system and plantar pressure were used during walking, running, cutting and jumping
At 2 years post operation.
Study Arms (2)
healthy volunteers
gait testing and MRI at baseline for healthy volunteers
ACL-deficient patients
gait testing and MRI at pre-operation, 6 months post-operation, 1 year post-operation, 2 years post-operation
Interventions
diagnostic tests including the gait testing and functional MRI
Eligibility Criteria
Thirty patients with ACL rupture undergoing ACL reconstruction surgery at the Institute of Sports Medicine, Peking University Third Hospital would be included in the study cohort were included, A total of 30 healthy volunteers with no history of musculoskeletal system injury or surgery in bilateral lower extremities would be included
You may qualify if:
- Unilateral ACL rupture of the knee
You may not qualify if:
- concomitant with other ligament injury or rupture, with history of surgery or musculoskeletal system injury of the contralateral knee, and the time from injury to operation more than 8 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shuang Ren
Peking University Third Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate researcher
Study Record Dates
First Submitted
July 2, 2021
First Posted
July 20, 2021
Study Start
August 1, 2021
Primary Completion
January 1, 2022
Study Completion
January 1, 2024
Last Updated
July 20, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share