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NCT Number: NCT02993679

Stability of the Knee Joint After Anterior Cruciate Ligament and Anterolateral Ligament Reconstruction

The objective of this randomised cohort study was to evaluate the knee rotational stability after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare it with the double-bundle ACL reconstruction technique (DB) and to analyse when the ALL is necessary to reconstruct.

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Key information

Conditions

Cruciate Ligament Rupture

Age range

17 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Background Rotational instability after the anterior cruciate ligament (ACL) injury and subsequent reconstruction may be caused by the rupture of the anterolateral structures of the knee, specifically the anterolateral ligament (ALL).

There are more techniques to improve the rotational stability of the knee. The objective of this randomised cohort study was: (1) To evaluate the knee rotational stability after the single-bundle ACL reconstruction (SB) with addition of the ALL reconstruction and to compare it with the double-bundle ACL reconstruction technique (DB). (2) To analyse when the ALL is necessary to reconstruct.

Methods 60 patients underwent the ACL reconstruction with the average age of 29.5 years. In thirty patient's knees the ACL was replaced with quadriceps muscle graft using the SB technique in combination with the ALL reconstruction by the gracilis graft (ALL group). With another thirty patients the ACL was reconstructed performing DB technique with the use of hamstring tendons (DB group). The rotational stability was studied before and after the reconstruction of the ACL in time "zero" using the computer navigation system. In the ALL group, the rotational stability was also analysed after the ALL reconstruction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The isolated ACL lesion
  • The absence of the previous surgery on the knee joint
  • The body mass index (BMI) less than 30.

Exclusion criteria

  • Associated injuries of the tissue around the knee joint

Treatment and study plan

reconstruction of the ACL and anterolateral ligament

Procedure

reconstruction of the ACL and anterolateral ligament

Primary outcomes

  1. Description of the change in the rotational stability of the knee joint after ACL and anterolateral ligament reconstruction.

    Time frame: 24 months after the operation

    Analyse of the rotational stability of the knee joint 24 months after the operation by the computerised navigation system.

Sponsors and collaborators

Lead sponsor

Hospital Znojmo

Other

Registry information

Official study title

Biomechanical Assessment of the Reconstruction of the Anterolateral Ligament During ACL Surgery. The In-vivo Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 15, 2016
Registry last updated
Dec 15, 2016

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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