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NCT04944693 Clinical Trial

Relationship Between Anterior Tibial Subluxation and the Prognosis of Anterior Cruciate Ligament Reconstruction.

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:
A Prospective Study of Anterior Tibial Subluxation in the Setting of Anterior Cruciate Ligament Reconstruction With 2-year Follow-up

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04944693
Other study ID # M2020384
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date July 1, 2026

Study information
Verified date November 2023
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

The value of preoperative anterior tibial subluxation (ATS) was used for the division of anterior cruciate ligament-injured patients in 2 groups. ATS was measured on pre- and postoperative MRI images. Patients were followed up 2 years after anterior cruciate ligament reconstruction, and patient reported outcomes (i.e. Lysholm score, etc.) were collected for further analysis.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 200
Est. completion date July 1, 2026
Est. primary completion date July 1, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: (1) Diagnosed anterior cruciate ligament injuries; (2) available preoperative MRI scans at our hospital. - Exclusion Criteria: Patients were excluded in the case of under 18 years of age, bilateral anterior cruciate ligament injuries, concomitant posterior cruciate ligament injuries, concomitant collateral ligament injuries, and no access to the preoperative MRI scan at our hospital. -

Study Design

Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Injuries

Intervention

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

Locations
Country Name City State
China Peking University Third Hospital Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patients reported outcomes (i.e. Lysholm score, etc.) at least 1-year postoperatively
Secondary MRI images Anterior tibial subluxation were measured on postoperative MRI images at least 1-year postoperatively
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