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Completed

NCT Number: NCT02795247

Comparison of 3 Techniques for Recreation of 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.

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Key information

Conditions

Anterior Cruciate Ligament Reconstruction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OrthoCarolina Sports Center

Charlotte, North Carolina, 28207, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anterior cruciate ligament reconstruction

Procedure

Other names: ACL Reconstruction

Primary outcomes

  1. 3D reconstructed CT imaging

    Time frame: 6 weeks Post-Operatively

    Used to measure tunnel position.

Secondary outcomes

  1. International Knee Documentation Committee (IKDC) Subjective Knee Evaluation

    Time frame: 6 weeks post-operative

    Change in IKDC subjective knee evaluation since before surgery

  2. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 6 weeks post-operative

    Change in KOOS since before surgery

  3. International Knee Documentation Committee (IKDC) Subjective Knee Evaluation

    Time frame: 6 months post-operative

    Change in IKDC subjective knee evaluation since before surgery

  4. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 6 months post-operative

    Change in KOOS since before surgery

  5. International Knee Documentation Committee (IKDC) Subjective Knee Evaluation

    Time frame: 1 year post-operative

    Change in IKDC subjective knee evaluation since before surgery

  6. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 1 year post-operative

    Change in KOOS since before surgery

  7. International Knee Documentation Committee (IKDC) Subjective Knee Evaluation

    Time frame: 2 year post-operative

    Change in IKDC subjective knee evaluation since before surgery

  8. Knee injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: 2 year post-operative

    Change in KOOS since before surgery

  9. Knee Laxity

    Time frame: 6 month post-operatively

    Pivot shift test will be used to a measure of knee laxity

Sponsors and collaborators

Lead sponsor

OrthoCarolina Research Institute, Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2023
First posted
Jun 10, 2016
Registry last updated
Apr 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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