Comparison of Different Anterior Cruciate Ligament Surger... | NCT04644497

Studies
Comparison of Different Anterior Cruciate Ligament Surgery Techniques in Skeletally Immature Patients.

NCT04644497

Sponsor

Aarhus University Hospital

Status

Completed

Last Update Posted

Oct 1, 2025Actual

Enrollment

120Actual

Phase

Not provided

Conditions

Anterior Cruciate Ligament Rupture

Interventions

ACL-reconstruction

Countries

Denmark

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

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2021Actual

Primary Completion Date

Aug 31, 2023Actual

Completion Date

Jul 30, 2025Actual

First Submitted Date

Nov 16, 2020

First Submission Date that Met QC Criteria

Nov 19, 2020

First Posted Date

Nov 25, 2020Actual

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

Sep 30, 2025

Last Update Posted Date

Oct 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This cohort study compares to groups of patients with reconstruction of anterior cruciate ligament (ACL). Patients in group 1 had ACL-reconstruction in the years 2001-2010 with a transphyseal drilling technique. Patient in group 2 had ACL-reconstruction in the years 2013-2018 with a physeal sparing technique.

Data including: x-ray exam, patient reported questionnaires and clinical evaluation will be compared between the 2 groups.

Detailed Description

Not provided

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

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transphyseal drilling technique			Procedure: ACL-reconstruction
Physeal sparing drilling technique			Procedure: ACL-reconstruction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACL-reconstruction	Procedure	Surgery technique in skeletally immature patients	Physeal sparing drilling technique Transphyseal drilling technique

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Leg-length differences	X-ray evaluation	2 Years Follow-up
Knee Angle differences	X-ray evaluation	2 Years Follow-up

Secondary Outcomes

Measure	Description	Time Frame
Knee Laxity	Clinical evaluation with rolimeter (arthrometer)	2 Years Follow-up
IKDC-Questionnaire	The International Knee Documentation Committee (IKDC Questionnaire)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ACL reconstruction as skeletally immature

Exclusion Criteria:

Other ligament injuries in index knee
Other ligament injuries in opposite knee
Revision ACL reconstruction
Pregnant
Not able to read or understand the danish languages

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Study population:

-ACL-reconstruction in one knee, operated in to periods (2001-2010 or 2013-2018) with two different techniques in each period.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aarhus University Hospital		Aarhus N		8200	Denmark

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