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
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Tear focused on measuring arthroscopic surgical procedure
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
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
NCT ID
NCT01025895
First Posted
December 3, 2009
Last Updated
December 3, 2009
Sponsor
Assaf-Harofeh Medical Center
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
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