Comparison of 3 Techniques for Recreation of Anterior Cruciate Ligament Anatomic Footprint

April 1, 2024 updated by: OrthoCarolina Research Institute, Inc.

Three Dimensional Computed Tomography Comparison of the Transtibial, Modified Transtibial and Anteromedial Portal Technique for Recreation of the Anterior Cruciate Ligament Anatomic Footprint

The purpose of this study is to compare the tomographic results of patients who underwent single-bundle anterior cruciate ligament reconstruction at the investigator's institution using the transtibial, accessory medial portal technique and the modified transtibial technique to determine which technique best recreates the anterior cruciate ligament anatomic footprint.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

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

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina Sports Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients presenting for single bundle ACL reconstruction, with or without associated partial meniscectomy or meniscal repair.
  • Skeletally mature patients
  • Patients who are able and willing to receive post-operative CT imaging of the affected knee

Exclusion Criteria:

  • Previous ACL reconstruction in the studied knee
  • Previous ACL injury or reconstruction in the contralateral kneeConcomitant non-ACL ligament reconstruction or osteotomy

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hybrid Transtibial Technique
Reconstruction of the ACL using the hybrid transtibial technique
Procedure: Anterior Cruciate Ligament Reconstruction
Other Names:
  • ACL Reconstruction
Active Comparator: Accessory Anteromedial Portal Technique
Reconstruction of the ACL using the accessory anteromedial portal technique
Procedure: Anterior Cruciate Ligament Reconstruction
Other Names:
  • ACL Reconstruction
Active Comparator: Transtibial Technique
Reconstruction of the ACL using the transtibial technique.
Procedure: Anterior Cruciate Ligament Reconstruction
Other Names:
  • ACL Reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3D reconstructed CT imaging
Time Frame: 6 weeks Post-Operatively
Used to measure tunnel position.
6 weeks Post-Operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
Time Frame: 6 weeks post-operative
Change in IKDC subjective knee evaluation since before surgery
6 weeks post-operative
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 6 weeks post-operative
Change in KOOS since before surgery
6 weeks post-operative
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
Time Frame: 6 months post-operative
Change in IKDC subjective knee evaluation since before surgery
6 months post-operative
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 6 months post-operative
Change in KOOS since before surgery
6 months post-operative
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
Time Frame: 1 year post-operative
Change in IKDC subjective knee evaluation since before surgery
1 year post-operative
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 1 year post-operative
Change in KOOS since before surgery
1 year post-operative
International Knee Documentation Committee (IKDC) Subjective Knee Evaluation
Time Frame: 2 year post-operative
Change in IKDC subjective knee evaluation since before surgery
2 year post-operative
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 2 year post-operative
Change in KOOS since before surgery
2 year post-operative
Knee Laxity
Time Frame: 6 month post-operatively
Pivot shift test will be used to a measure of knee laxity
6 month post-operatively

Collaborators and Investigators

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

Sponsor

OrthoCarolina Research Institute, Inc.

Investigators

  • Principal Investigator: Dana P Piasecki, MD, OrthoCarolina Research Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 26, 2016

Primary Completion (Actual)

April 27, 2018

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

June 6, 2016

First Submitted That Met QC Criteria

June 8, 2016

First Posted (Estimated)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • SPORT037

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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