search
Back to results

Study of Single And Double Bundle Anterior Cruciate Ligament (ACL) Graft Cross-sectional Dimensions

Primary Purpose

Rupture of Anterior Cruciate Ligament

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
single bundle ACL reconstruction
double bundle ACL 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

Eligibility Criteria

10 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ACL rupture patients aged between 10 to 50 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 inflammatory or systemic disease, neuromuscular disease in the lower limbs,any recent knee infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    single bundle ACLR

    double bundle ACLR

    Arm Description

    patients undergo single bundle ACL reconstruction

    patients undergo double bundle ACL reconstruction

    Outcomes

    Primary Outcome Measures

    cross-sectional area of the reconstructed ACL
    long to short axis ratio of the cross-sectional area of the reconstructed ACL
    long axis of the cross-sectional area of the reconstructed ACL
    short axis of the cross-sectional area of the reconstructed ACL

    Secondary Outcome Measures

    Full Information

    First Posted
    July 13, 2016
    Last Updated
    July 14, 2016
    Sponsor
    Peking University Third Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02834962
    Brief Title
    Study of Single And Double Bundle Anterior Cruciate Ligament (ACL) Graft Cross-sectional Dimensions
    Official Title
    Study of Single And Double Bundle ACL Graft Cross-sectional Dimensions Compared With Native ACL
    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 2017 (Anticipated)
    Study Completion Date
    August 2017 (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
    To study the difference between single and double bundle ACL graft cross-sectional dimensions compared with native ACL using postoperative 3-D MRI.
    Detailed Description
    The investigators divide 100 patients with ACL rupture into 2 groups. Group A undergo single bundle anterior cruciate ligament reconstruction (ACLR). Group B undergo double bundle ACL reconstruction. At 3-6 weeks post operation, all the patients undergo 3-D MRI examination of both knees. The investigators reconstruct 3-D models of reconstructed ACL and native ACL, and compare the difference between single and double bundle graft.

    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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    single bundle ACLR
    Arm Type
    Experimental
    Arm Description
    patients undergo single bundle ACL reconstruction
    Arm Title
    double bundle ACLR
    Arm Type
    Active Comparator
    Arm Description
    patients undergo double bundle ACL reconstruction
    Intervention Type
    Procedure
    Intervention Name(s)
    single bundle ACL reconstruction
    Intervention Description
    anterior cruciate ligament reconstruction using single bundle technique
    Intervention Type
    Procedure
    Intervention Name(s)
    double bundle ACL reconstruction
    Intervention Description
    anterior cruciate ligament reconstruction using double bundle technique
    Primary Outcome Measure Information:
    Title
    cross-sectional area of the reconstructed ACL
    Time Frame
    3-6 weeks
    Title
    long to short axis ratio of the cross-sectional area of the reconstructed ACL
    Time Frame
    3-6 weeks
    Title
    long axis of the cross-sectional area of the reconstructed ACL
    Time Frame
    3-6 weeks
    Title
    short axis of the cross-sectional area of the reconstructed ACL
    Time Frame
    3-6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ACL rupture patients aged between 10 to 50 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 inflammatory 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
    Organizational Affiliation
    Peking University Third Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Single And Double Bundle Anterior Cruciate Ligament (ACL) Graft Cross-sectional Dimensions

    We'll reach out to this number within 24 hrs