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NCT04644497 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

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
See also
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Recruiting NCT03229369 - Association of ALL and ACL Reconstruction Versus Isolated ACL Reconstruction in High-risk Population: a RCT. N/A
Completed NCT01267435 - Evaluation of Tibial and Femoral Tunnel Position After Arthroscopic Reconstruction of the Anterior Cruciate Ligament Phase 2
Completed NCT05057442 - The Effects of Remnant-Preserving Anterior Cruciate Ligament Reconstruction on Proprioception and Functionality