NCT04644497

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 16, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

January 31, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

November 16, 2020

Last Update Submit

September 30, 2025

Conditions

Anterior Cruciate Ligament Rupture

Outcome Measures

Primary Outcomes (2)

  • Leg-length differences

    X-ray evaluation

    2 Years Follow-up

  • Knee Angle differences

    X-ray evaluation

    2 Years Follow-up

Secondary Outcomes (4)

  • Knee Laxity

    2 Years Follow-up

  • IKDC-Questionnaire

    2 Years Follow-up

  • Tegner-Questionnaire

    2 Years Follow-up

  • KOOS- Questionnaire

    2 Years Follow-up

Study Arms (2)

Transphyseal drilling technique

Procedure: ACL-reconstruction

Physeal sparing drilling technique

Procedure: ACL-reconstruction

Interventions

ACL-reconstructionPROCEDURE

Surgery technique in skeletally immature patients

Physeal sparing drilling techniqueTransphyseal drilling technique

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • ACL reconstruction as skeletally immature

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 25, 2020

Study Start

January 31, 2021

Primary Completion

August 31, 2023

Study Completion

July 30, 2025

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)