search
Back to results

Anterior Cruciate Ligament (ACL) Reconstruction: Single Bundle Versus Double Bundle

Primary Purpose

Anterior Cruciate Ligament Tear

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
acl reconstruction - double bundle technique
acle reconstruction - single bundle technique
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Tear focused on measuring arthroscopic surgical procedure

Eligibility Criteria

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

Inclusion Criteria:

  • knee instability with a history of ACL tear
  • diagnosed ACL tear according to MRI
  • age range 16-40.

Exclusion Criteria:

  • previous surgery in the knees
  • multiple ligament raptures
  • partial ACL tear
  • severe cartilage degeneration
  • genovaruse/genovalgus
  • thin hamstrings tendons
  • oper epiphysis in the knee joint
  • patient with muscle/neurological problem that increases the tendency to fall

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    single bundle

    double bundle

    Arm Description

    acl reconstruction - single bundle technique

    acl reconstruction - double bundle technique

    Outcomes

    Primary Outcome Measures

    WOMAC, VAS, SF-36, Lisholm, Knee society score, isokinetic muscle strength testing, Single HOP test , Tripple Hop Test

    Secondary Outcome Measures

    Full Information

    First Posted
    December 3, 2009
    Last Updated
    December 3, 2009
    Sponsor
    Assaf-Harofeh Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01025895
    Brief Title
    Anterior Cruciate Ligament (ACL) Reconstruction: Single Bundle Versus Double Bundle
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2010 (undefined)
    Primary Completion Date
    January 2011 (Anticipated)
    Study Completion Date
    January 2013 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Assaf-Harofeh Medical Center

    4. Oversight

    5. Study Description

    Brief Summary
    ACL tear is a common injury among athletes. The recommended treatment includes reconstruction of the ligament. The common reconstruction technique is single bundle reconstruction. However, this technique does not simulate the natural structure of the ligament. The purpose of the study is to compare between the common procedure, Single Bundle reconstruction with the Double Bundle reconstruction technique.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anterior Cruciate Ligament Tear
    Keywords
    arthroscopic surgical procedure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    single bundle
    Arm Type
    Active Comparator
    Arm Description
    acl reconstruction - single bundle technique
    Arm Title
    double bundle
    Arm Type
    Experimental
    Arm Description
    acl reconstruction - double bundle technique
    Intervention Type
    Procedure
    Intervention Name(s)
    acl reconstruction - double bundle technique
    Intervention Type
    Procedure
    Intervention Name(s)
    acle reconstruction - single bundle technique
    Primary Outcome Measure Information:
    Title
    WOMAC, VAS, SF-36, Lisholm, Knee society score, isokinetic muscle strength testing, Single HOP test , Tripple Hop Test
    Time Frame
    pre-op. 1 day post op., 7-14 days post op., 6 weeks post op., 12 weeks post op., 26 weeks post op., 1 year post op., 2 years post op.

    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: knee instability with a history of ACL tear diagnosed ACL tear according to MRI age range 16-40. Exclusion Criteria: previous surgery in the knees multiple ligament raptures partial ACL tear severe cartilage degeneration genovaruse/genovalgus thin hamstrings tendons oper epiphysis in the knee joint patient with muscle/neurological problem that increases the tendency to fall

    12. IPD Sharing Statement

    Learn more about this trial

    Anterior Cruciate Ligament (ACL) Reconstruction: Single Bundle Versus Double Bundle

    We'll reach out to this number within 24 hrs