NCT04462432

Brief Summary

High incidence rate of knee osteoarthritis and gait analysis are important for early assessment of biomechanics. ACL injury is an ideal clinical model for studying knee osteoarthritis. To clarify the mechanism between the biomechanical status of knee joint and the change of gait touch information, and to provide scientific basis for quantifying and evaluating the biomechanical status of knee joint in dynamic load-bearing state.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

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 2, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 8, 2020

Status Verified

June 1, 2020

Enrollment Period

2.9 years

First QC Date

June 30, 2020

Last Update Submit

July 6, 2020

Conditions

Anterior Cruciate Ligament Injuries

Keywords

anterior cruciate ligamentgait analysisplantar pressuremulti-body dynamics modeling

Outcome Measures

Primary Outcomes (15)

  • walking speed

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    On the day of enrollment.

  • walking speed

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    at 24th weeks after Anterior Cruciate Ligament reconstruction.

  • walking speed

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    at 48th weeks after Anterior Cruciate Ligament reconstruction.

  • ground reaction force

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    On the day of enrollment.

  • ground reaction force

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    at 24th weeks after Anterior Cruciate Ligament reconstruction.

  • ground reaction force

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    at 48th weeks after Anterior Cruciate Ligament reconstruction.

  • knee flexion angle

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    On the day of enrollment.

  • knee flexion angle

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    at 24th weeks after Anterior Cruciate Ligament reconstruction.

  • knee flexion angle

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    at 48th weeks after Anterior Cruciate Ligament reconstruction.

  • the moment of knee extension in the gait cycle

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    On the day of enrollment.

  • the moment of knee extension in the gait cycle

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    at 24th weeks after Anterior Cruciate Ligament reconstruction.

  • the moment of knee extension in the gait cycle

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    at 48th weeks after Anterior Cruciate Ligament reconstruction.

  • the moment of knee flexion in the gait cycle

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    On the day of enrollment.

  • the moment of knee flexion in the gait cycle

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    at 24th weeks after Anterior Cruciate Ligament reconstruction.

  • the moment of knee flexion in the gait cycle

    Three-dimensional gait analysis system and plantar pressure were used during walking, jogging, cutting and jumping.

    at 48th weeks after Anterior Cruciate Ligament reconstruction.

Secondary Outcomes (1)

  • The International Knee Documentation Committee (IKDC) score

    On the day of enrollment, at 24th and 48th weeks after Anterior Cruciate Ligament reconstruction.

Study Arms (2)

Anterior Cruciate Ligament injury and reconstruction group

According to the previous clinical diagnosis, volunteers who has never suffered the Anterior Cruciate Ligament injury.

Other: no intervention

normal control group

According to the previous clinical diagnosis, volunteers who has never suffered the lower extremity sports injuries.

Other: no intervention

Interventions

no interventionOTHER

This is an observation study, with no intervention.

Anterior Cruciate Ligament injury and reconstruction groupnormal control group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Inclusion criteria: Age: 18-35 years old. Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital. With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures). All participants have no known disorders or diseases other than ACL rupture. Exclusion criteria: Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.

You may qualify if:

  • years old
  • Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital.
  • With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures).
  • All participants have no known disorders or diseases other than ACL rupture.

You may not qualify if:

  • Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Hongshi Huang, Doctor

    Peking University Third Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 8, 2020

Study Start

March 2, 2017

Primary Completion

January 8, 2020

Study Completion

December 31, 2022

Last Updated

July 8, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)