Back to resultsComparative Study of the Inclination Angle and Complications of Eccentric Grafts Position in ACL Reconstruction and Normal ACL: Retrospective Cohort
Primary Purpose
Anterior Cruciate Ligament Injuries
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interference screw
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring ACL, screw fixation, graft inclination, reconstruction
Eligibility Criteria
Inclusion Criteria:
- magnetic resonance imaging (MRI) of patients with ACL reconstruction was compared to MRI in which ACL was intact.
- patients with isolated ACL injury who underwent ACL reconstruction surgery using quadripled hamstrings graft and operated by a single senior surgeon
- Both pre-operative and post-operative MRI should be available for assessment
- No history of trauma in the post-operative or rehabilitation period
Exclusion Criteria:
- Concomitant bony or other ligament injury to the same knee
- history of previous surgery to the same knee
- Revision ACL reconstruction surgery
- surgery done at other center or by other doctors at our institute
- Pre-operative and/or post-operative MRI not available
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Anterior cruciate ligament normal
Anterior cruciate ligament reconstruction
Arm Description
normal Anterior cruciate ligament reconstruction
Anterior cruciate ligament reconstruction and Position screw fixation
Outcomes
Primary Outcome Measures
Inclination angle
Mean anterior cruciate ligament inclination angle in sagital x-ray (degree)
Secondary Outcome Measures
post-operative complications
number of participants with revision, infection, reflex sympathetic dystrophy and re-rupture
Full Information
NCT ID
NCT04188704
First Posted
November 30, 2019
Last Updated
December 4, 2019
Sponsor
Ramathibodi Hospital
Collaborators
Thammasat University
1. Study Identification
Unique Protocol Identification Number
NCT04188704
Brief Title
Comparative Study of the Inclination Angle and Complications of Eccentric Grafts Position in ACL Reconstruction and Normal ACL: Retrospective Cohort
Official Title
Comparative Study of the Inclination Angle and Complications of Eccentric Grafts Position in ACL Reconstruction and Normal ACL: Retrospective Cohort
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 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
No
5. Study Description
Brief Summary
The anatomic ACL reconstruction aims at functional restoration of the ACL to its native dimensions, collagen orientation and insertion sites. Even if the anatomic foot prints are correctly chosen for the tibial and femoral tunnels does the position of interference screw in the tibial tunnel alter the ACL orientation? The study hypothesized that the position of interference screw in the tibial tunnel would alter the graft orientation in anatomic ACL reconstruction. The purpose of this study was to compare graft orientation and inclination angle with posterolateral and anteromedial interference screw position in tibial tunnel in aperture fixation techniques.
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, screw fixation, graft inclination, reconstruction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anterior cruciate ligament normal
Arm Type
Placebo Comparator
Arm Description
normal Anterior cruciate ligament reconstruction
Arm Title
Anterior cruciate ligament reconstruction
Arm Type
Experimental
Arm Description
Anterior cruciate ligament reconstruction and Position screw fixation
Intervention Type
Procedure
Intervention Name(s)
Interference screw
Intervention Description
Anterior cruciate ligament reconstruction (anterior screw fixation or posterior screw fixation)
Primary Outcome Measure Information:
Title
Inclination angle
Description
Mean anterior cruciate ligament inclination angle in sagital x-ray (degree)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
post-operative complications
Description
number of participants with revision, infection, reflex sympathetic dystrophy and re-rupture
Time Frame
6 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:
magnetic resonance imaging (MRI) of patients with ACL reconstruction was compared to MRI in which ACL was intact.
patients with isolated ACL injury who underwent ACL reconstruction surgery using quadripled hamstrings graft and operated by a single senior surgeon
Both pre-operative and post-operative MRI should be available for assessment
No history of trauma in the post-operative or rehabilitation period
Exclusion Criteria:
Concomitant bony or other ligament injury to the same knee
history of previous surgery to the same knee
Revision ACL reconstruction surgery
surgery done at other center or by other doctors at our institute
Pre-operative and/or post-operative MRI not available
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Study of the Inclination Angle and Complications of Eccentric Grafts Position in ACL Reconstruction and Normal ACL: Retrospective Cohort
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