NCT04944693

Brief Summary

To identify the improvement of anterior tibial subluxation (ATS) and the relationship between ATS and patient reported outcome on pre- and postoperative anterior cruciate ligament-injured MRI images.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress99%
Mar 2021Jul 2026

Study Start

First participant enrolled

March 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

4 months

First QC Date

June 27, 2021

Last Update Submit

November 20, 2023

Conditions

Anterior Cruciate Ligament Injuries

Keywords

anterior tibial subluxation

Outcome Measures

Primary Outcomes (1)

  • Patients reported outcomes

    (i.e. Lysholm score, etc.)

    at least 1-year postoperatively

Secondary Outcomes (1)

  • MRI images

    at least 1-year postoperatively

Study Arms (2)

Cohort 1

Anterior cruciate ligament-injured patients with excessive ATS

Other: Different ATS values.

Cohort 2

Anterior cruciate ligament-injured patients with minimal ATS

Other: Different ATS values.

Interventions

Different ATS values.OTHER

Observational, different ATS values were measured on MRI images and were regarded as "interventions" for different cohorts.

Cohort 1Cohort 2

Eligibility Criteria

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

anterior cruciate ligament-injured patients that had suffered from anterior cruciate ligament injury.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Cheng Wang, M.D.

    Peking University Third Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 27, 2021

First Posted

June 29, 2021

Study Start

March 1, 2021

Primary Completion

July 1, 2021

Study Completion (Estimated)

July 1, 2026

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)