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Anatomic Anterior Cruciate Ligament With Short Hamstring Graft Compare With a Standard Hamstring Graft Technique

Primary Purpose

Anterior Cruciate Ligament Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anatomic anterior cruciate ligament with short hamstring graft technique
Anatomic anterior cruciate ligament with a standard hamstring graft technique
Sponsored by
Ramathibodi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring ACL, short hamstring graft, standard hamstring graft

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with anterior cruciate ligamentous injury with the diagnosis of injured ligaments was made based on a detailed history of the knee injury, physical examination on pathologic status and abnormal laxity, routinely performed plain radiographs and MRI scans, and the findings at surgery.
  • Patients who have closed growth plates.
  • Patients who younger than 60 years old.
  • Patients who absence of ligament injury to the opposite knee.

Exclusion Criteria:

  • Patients with a combined ligament injury as folling:

    1. Posterior cruciate ligament
    2. The lateral collateral ligament
    3. The posterolateral corner structures of the knee
    4. Medial collateral ligament.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Anatomic anterior cruciate ligament with short hamstring

    Anatomic anterior cruciate ligament with standard hamstring

    Arm Description

    Anatomic anterior cruciate ligament with short hamstring graft

    Anatomic anterior cruciate ligament with standard hamstring graft

    Outcomes

    Primary Outcome Measures

    Visual analog score
    visual analog score rang from 0-10 (minimum=0, maximun=10) and the higher values represent a worse outcome?)

    Secondary Outcome Measures

    range of motion
    range of motion range from 0-160 degree and the higher values represent a better outcome
    complication
    number of participant who have infection, stiffness and re-operation

    Full Information

    First Posted
    May 13, 2019
    Last Updated
    June 18, 2019
    Sponsor
    Ramathibodi Hospital
    Collaborators
    Thammasat University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03954925
    Brief Title
    Anatomic Anterior Cruciate Ligament With Short Hamstring Graft Compare With a Standard Hamstring Graft Technique
    Official Title
    Anatomic Anterior Cruciate Ligament With Short Hamstring Graft Compare With a Standard Hamstring Graft Technique: Prospective Cohort Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 1, 2014 (Actual)
    Primary Completion Date
    September 1, 2015 (Actual)
    Study Completion Date
    March 1, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ramathibodi Hospital
    Collaborators
    Thammasat University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    this study was to evaluate the functional outcome of quadruple hamstring graft in femoral tunnel less than 15 mm and morethan or equal 15 mm of ACL reconstruction. The hypothesize that no difference intermediate follow up ( 6 month - 24 month) of functional outcome and clinical evaluation between short and normal femoral tunnel graft length of hamstring tendon ACL reconstruction.
    Detailed Description
    The patient recruitment (N=29) and baseline data collection were done at our institute between March2014-September 2015. The inclusion criteria were patients with anterior cruciate ligamentous injury who needed ligamentous reconstruction, closed growth plates and younger than 60 years old, absence of ligament injury to the opposite knee. The exclusion criteria are patients who did not want to participate in this study or patient with failed anterior cruciate ligamentous reconstruction. All the procedure of anterior cruciate ligament reconstructions were performed by the senior authors (B.C). Semitendinosus and gracilis tendons were harvested through an oblique approach medial to the tibial tubercle in all patients. Complete anterior cruciate ligament was confirmed at arthroscopy. Associated intra-articular injuries such as meniscus tear and cartilage lesions were fixed at of the index operation .The femoral tunnel were drilled though the AM portal.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anterior Cruciate Ligament Injuries
    Keywords
    ACL, short hamstring graft, standard hamstring graft

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    29 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Anatomic anterior cruciate ligament with short hamstring
    Arm Type
    Active Comparator
    Arm Description
    Anatomic anterior cruciate ligament with short hamstring graft
    Arm Title
    Anatomic anterior cruciate ligament with standard hamstring
    Arm Type
    Active Comparator
    Arm Description
    Anatomic anterior cruciate ligament with standard hamstring graft
    Intervention Type
    Procedure
    Intervention Name(s)
    Anatomic anterior cruciate ligament with short hamstring graft technique
    Intervention Description
    ACL and short hamstring graft
    Intervention Type
    Procedure
    Intervention Name(s)
    Anatomic anterior cruciate ligament with a standard hamstring graft technique
    Intervention Description
    ACL with standard hamstring graft
    Primary Outcome Measure Information:
    Title
    Visual analog score
    Description
    visual analog score rang from 0-10 (minimum=0, maximun=10) and the higher values represent a worse outcome?)
    Time Frame
    18 months
    Secondary Outcome Measure Information:
    Title
    range of motion
    Description
    range of motion range from 0-160 degree and the higher values represent a better outcome
    Time Frame
    18 months
    Title
    complication
    Description
    number of participant who have infection, stiffness and re-operation
    Time Frame
    18 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with anterior cruciate ligamentous injury with the diagnosis of injured ligaments was made based on a detailed history of the knee injury, physical examination on pathologic status and abnormal laxity, routinely performed plain radiographs and MRI scans, and the findings at surgery. Patients who have closed growth plates. Patients who younger than 60 years old. Patients who absence of ligament injury to the opposite knee. Exclusion Criteria: Patients with a combined ligament injury as folling: Posterior cruciate ligament The lateral collateral ligament The posterolateral corner structures of the knee Medial collateral ligament.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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