NCT04953546

Brief Summary

With the apex of the deep cartilage (ADC) as the symbol, the consistency of the two methods in the postoperatively computed tomography (CT) and microscopic evaluation of the position of the femoral tract of the anterior cruciate ligament (ACL) was studied.Expected results:P1 and P2, D1 and D2 were positively correlated, and the linear relationship was significant. Bland-Altman diagram shows a good consistency.

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
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

July 8, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

June 29, 2021

Last Update Submit

July 7, 2021

Conditions

Keywords

anterior cruciate ligamentcomputed tomographythe apex of the deep cartilagemicroscopic evaluation

Outcome Measures

Primary Outcomes (3)

  • The horizontal distance from the ADC to the anterior bone margin

    The patients were measured microscopically at the time of surgery and again on CT after surgery.

    On the 1 day of enrollment.

  • the horizontal distance from the center point of the bone tract

    The patients were measured microscopically at the time of surgery and again on CT

    On the 1 day of enrollment.

  • the distance from the center point of the bone tract to the lower bone margin

    The patients were measured microscopically at the time of surgery and again on CT

    On the 1 day of enrollment.

Study Arms (1)

ACL group

According to the previous clinical diagnosis, volunteers who has suffered the ACL injury.

Other: No Intervention

Interventions

This is an observation study, with no intervention

ACL group

Eligibility Criteria

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

Inclusion Criteria: Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital.

You may qualify if:

  • 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:

  • Other injuries affecting movement performance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Yong Ma, Doctor

    Peking University Third Hospital

    STUDY CHAIR

Central Study Contacts

Weili Shi, Doctor

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 8, 2021

Study Start

June 1, 2021

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

July 8, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations