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Study of the Anatomical Direct Insertion Anterior Cruciate Ligament Reconstruction

Primary Purpose

Rupture of Anterior Cruciate Ligament

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
direct insertion anterior cruciate ligament reconstruction
single bundle anterior cruciate ligament reconstruction
double bundle anterior cruciate ligament reconstruction
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rupture of Anterior Cruciate Ligament focused on measuring Anterior Cruciate Ligament Reconstruction, Direct Insertion of Anterior Cruciate Ligament

Eligibility Criteria

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

Inclusion Criteria:

  • ACL rupture patients aged between 16 to 40 years

Exclusion Criteria:

  • combined severe injuries to the operated knee (additional ligament rupture, major meniscus loss, patella instability, cartilage damage >2°, pathologic leg axis deviation)
  • any injury or surgery to the contralateral knee
  • any infammatory or systemic disease, neuromuscular disease in the lower limbs, any recent knee infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Active Comparator

    Arm Label

    direct insertion single bundle ACLR

    anatomical double bundle ACLR

    anatomical single bundle ACLR

    direct insertion double bundle ACLR

    Arm Description

    Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using single bundle technique.

    Patients with ACL rupture undergo double bundle anterior cruciate ligament reconstruction.

    Patients with ACL rupture undergo single bundle anterior cruciate ligament reconstruction.

    Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using double bundle technique.

    Outcomes

    Primary Outcome Measures

    Lysholm score of the knee
    Lysholm score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
    Tegner score of the knee
    Tegner score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
    IKDC score of the knee
    IKDC score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score

    Secondary Outcome Measures

    KT-2000 of the knee
    KT-2000 of the knee was evaluated preoperatively and at 2 years post operation.

    Full Information

    First Posted
    July 11, 2016
    Last Updated
    July 13, 2016
    Sponsor
    Peking University Third Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02833454
    Brief Title
    Study of the Anatomical Direct Insertion Anterior Cruciate Ligament Reconstruction
    Official Title
    Anterior Cruciate Ligament Reconstruction (ACLR) Using Direct Insertion Technique or Traditional Technique With Single and Double Bundle Procedure.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    July 2018 (Anticipated)
    Study Completion Date
    August 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University Third Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of the study is to study the effect of anatomical direct insertion ACL reconstruction compared with conventional anatomical ACL reconstruction.
    Detailed Description
    The investigators divide 320 patients with ACL rupture into 4 groups, each group has 80 patients. The operation technique is different among the groups: group A: conventional anatomical double bundle acl reconstruction, group B: conventional anatomical single bundle acl reconstruction, group DA: direct insertion double bundle acl reconstruction, group DSB: direct insertion single bundle acl reconstruction. The investigators compare the results of the patients of each group at 2 years of surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rupture of Anterior Cruciate Ligament
    Keywords
    Anterior Cruciate Ligament Reconstruction, Direct Insertion of Anterior Cruciate Ligament

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    320 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    direct insertion single bundle ACLR
    Arm Type
    Active Comparator
    Arm Description
    Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using single bundle technique.
    Arm Title
    anatomical double bundle ACLR
    Arm Type
    Experimental
    Arm Description
    Patients with ACL rupture undergo double bundle anterior cruciate ligament reconstruction.
    Arm Title
    anatomical single bundle ACLR
    Arm Type
    Experimental
    Arm Description
    Patients with ACL rupture undergo single bundle anterior cruciate ligament reconstruction.
    Arm Title
    direct insertion double bundle ACLR
    Arm Type
    Active Comparator
    Arm Description
    Patients with ACL rupture undergo direct insertion anterior cruciate ligament reconstruction using double bundle technique.
    Intervention Type
    Procedure
    Intervention Name(s)
    direct insertion anterior cruciate ligament reconstruction
    Intervention Description
    ACL reconstruction based on direct insertion of ACL.
    Intervention Type
    Procedure
    Intervention Name(s)
    single bundle anterior cruciate ligament reconstruction
    Intervention Description
    anterior cruciate ligament reconstruction using single bundle technique
    Intervention Type
    Procedure
    Intervention Name(s)
    double bundle anterior cruciate ligament reconstruction
    Intervention Description
    anterior cruciate ligament reconstruction using double bundle technique
    Primary Outcome Measure Information:
    Title
    Lysholm score of the knee
    Description
    Lysholm score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
    Time Frame
    two years
    Title
    Tegner score of the knee
    Description
    Tegner score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
    Time Frame
    two years
    Title
    IKDC score of the knee
    Description
    IKDC score of the knee was evaluated preoperatively and at 2 years post operation . Scale name:score
    Time Frame
    two years
    Secondary Outcome Measure Information:
    Title
    KT-2000 of the knee
    Description
    KT-2000 of the knee was evaluated preoperatively and at 2 years post operation.
    Time Frame
    two years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ACL rupture patients aged between 16 to 40 years Exclusion Criteria: combined severe injuries to the operated knee (additional ligament rupture, major meniscus loss, patella instability, cartilage damage >2°, pathologic leg axis deviation) any injury or surgery to the contralateral knee any infammatory or systemic disease, neuromuscular disease in the lower limbs, any recent knee infection
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yu Jia-Kuo, MD
    Phone
    86-10-82267392
    Email
    yujiakuo@126.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liu Yang, MD
    Phone
    86-10-82267019
    Email
    surgeonliuyang@sina.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jia-Kuo Yu, MD
    Organizational Affiliation
    Peking University Third Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Study of the Anatomical Direct Insertion Anterior Cruciate Ligament Reconstruction

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