Anterior Tibial Subluxation in the Setting of ACL-injury... | NCT04956536

Studies
Anterior Tibial Subluxation in the Setting of ACL-injury and After ACL Reconstruction

NCT04956536

Sponsor

Peking University Third Hospital

Status

Unknown status

Last Update Posted

Nov 22, 2023Actual

Enrollment

297Estimated

Phase

Not provided

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Demographic data and MRI images were extracted and analyzed

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Jan 1, 2021Actual

Completion Date

Jul 1, 2026Estimated

First Submitted Date

Jun 30, 2021

First Submission Date that Met QC Criteria

Jul 8, 2021

First Posted Date

Jul 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2023

Last Update Posted Date

Nov 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To identify the related factors for anterior tibial subluxation (ATS) on anterior cruciate ligament-injured MRI images.

Detailed Description

Demographic data and MRI images of anterior cruciate ligament-injured patients were retrospectively analyzed. Anterior tibial subluxation was measured and factors were examined via univariate and multivariate analysis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

297Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1		Anterior cruciate ligament-injured patients	Other: Demographic data and MRI images were extracted and analyzed

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Demographic data and MRI images were extracted and analyzed	Other	Demographic data and MRI images were extracted and analyzed. Related factors for anterior tibial subluxation were examined in anterior cruciate ligament-injured patients.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anterior tibial subluxation	Anterior tibial subluxation was measured preoperatively.	Preoperatively

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed anterior cruciate ligament injuries
Available preoperative MRI images 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
No access to the preoperative MRI scan at our hospital

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

ACL-injured patients that had suffered from ACL injury and underwent primary ACL reconstruction between January 1, 2013 and December 31, 2015.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cheng Wang, M.D.	Peking University Third Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital		Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070598	Anterior Cruciate Ligament Injuries

Ancestor Terms

ID	Term
D007718	Knee Injuries
D007869	Leg Injuries
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003710	Demography

Ancestor Terms

ID	Term
D011154	Population Characteristics
D015991	Epidemiologic Measurements
D011634	Public Health
D004778	Environment and Public Health

Browse Leaves

Not provided

Browse Branches

Not provided