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

Primary Purpose

Cruciate Ligament Rupture

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
reconstruction of the ACL and anterolateral ligament
Sponsored by
Hospital Znojmo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cruciate Ligament Rupture

Eligibility Criteria

17 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    double-bundle ACL reconstruction

    anterolateral ligament reconstruction

    Arm Description

    surgical reconstruction of the anterior cruciate ligament

    surgical reconstruction of the anterolateral ligament

    Outcomes

    Primary Outcome Measures

    Description of the change in the rotational stability of the knee joint after ACL and anterolateral ligament reconstruction.
    Analyse of the rotational stability of the knee joint 24 months after the operation by the computerised navigation system.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 4, 2016
    Last Updated
    December 14, 2016
    Sponsor
    Hospital Znojmo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02993679
    Brief Title
    Stability of the Knee Joint After Anterior Cruciate Ligament and Anterolateral Ligament Reconstruction
    Official Title
    Biomechanical Assessment of the Reconstruction of the Anterolateral Ligament During ACL Surgery. The In-vivo Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    November 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Znojmo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cruciate Ligament Rupture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    double-bundle ACL reconstruction
    Arm Type
    Other
    Arm Description
    surgical reconstruction of the anterior cruciate ligament
    Arm Title
    anterolateral ligament reconstruction
    Arm Type
    Other
    Arm Description
    surgical reconstruction of the anterolateral ligament
    Intervention Type
    Procedure
    Intervention Name(s)
    reconstruction of the ACL and anterolateral ligament
    Intervention Description
    reconstruction of the ACL and anterolateral ligament
    Primary Outcome Measure Information:
    Title
    Description of the change in the rotational stability of the knee joint after ACL and anterolateral ligament reconstruction.
    Description
    Analyse of the rotational stability of the knee joint 24 months after the operation by the computerised navigation system.
    Time Frame
    24 months after the operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    17 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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