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

Anterior Cruciate Ligament Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04644497
• Other study ID #: EC 1-10-72-246-20
• Status: Active, not recruiting
• Start date: January 31, 2021
• Est. completion date: November 30, 2025

Study information

• Verified date: January 2024
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: November 30, 2025
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

Procedure:
• ACL-reconstruction
Surgery technique in skeletally immature patients

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leg-length differences	X-ray evaluation	2 Years Follow-up
Primary	Knee Angle differences	X-ray evaluation	2 Years Follow-up
Secondary	Knee Laxity	Clinical evaluation with rolimeter (arthrometer)	2 Years Follow-up
Secondary	IKDC-Questionnaire	The International Knee Documentation Committee (IKDC Questionnaire)	2 Years Follow-up
Secondary	Tegner-Questionnaire	Tegner (Activity function score)	2 Years Follow-up
Secondary	KOOS- Questionnaire	Knee injury and Osteoarthritis Outcome Score (KOOS)	2 Years Follow-up