NCT04968665

Brief Summary

Explore The Mechanism for the Effects of Joint Biomechanical Properties on Medial Cartilage of Tibiofemoral Joint Degeneration

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

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

First Submitted

Initial submission to the registry

July 2, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

July 2, 2021

Last Update Submit

July 8, 2021

Conditions

Keywords

sports biomechanicsjoint loadinganterior cruciate ligament reconstructioncartilage degenerationfunctional MRI

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

Diagnostic Test: gait testing, functional MRI

ACL-deficient patients

gait testing and MRI at pre-operation, 6 months post-operation, 1 year post-operation, 2 years post-operation

Diagnostic Test: gait testing, functional MRI

Interventions

diagnostic tests including the gait testing and functional MRI

ACL-deficient patientshealthy volunteers

Eligibility Criteria

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

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

Anterior Cruciate Ligament Injuries

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Shuang Ren

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

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