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
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
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.
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
NCT ID
NCT03954925
First Posted
May 13, 2019
Last Updated
June 18, 2019
Sponsor
Ramathibodi Hospital
Collaborators
Thammasat University
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
Learn more about this trial
Anatomic Anterior Cruciate Ligament With Short Hamstring Graft Compare With a Standard Hamstring Graft Technique
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