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

January 30, 2024 updated by: Martin Lind, Aarhus University Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Transphyseal drilling technique
Procedure: ACL-reconstruction
Surgery technique in skeletally immature patients
Physeal sparing drilling technique
Procedure: ACL-reconstruction
Surgery technique in skeletally immature patients

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Laxity
Time Frame: 2 Years Follow-up
Clinical evaluation with rolimeter (arthrometer)
2 Years Follow-up
IKDC-Questionnaire
Time Frame: 2 Years Follow-up
The International Knee Documentation Committee (IKDC Questionnaire)
2 Years Follow-up
Tegner-Questionnaire
Time Frame: 2 Years Follow-up
Tegner (Activity function score)
2 Years Follow-up
KOOS- Questionnaire
Time Frame: 2 Years Follow-up
Knee injury and Osteoarthritis Outcome Score (KOOS)
2 Years Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2021

Primary Completion (Actual)

August 31, 2023

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (Actual)

November 25, 2020

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC 1-10-72-246-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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