Comparative Study of the Inclination Angle and Complications of Eccentric Grafts Position in ACL Reconstruction and Normal ACL: Retrospective Cohort
1 other identifier
interventional
108
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2013
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFirst Posted
Study publicly available on registry
December 6, 2019
CompletedDecember 6, 2019
December 1, 2019
5.9 years
November 30, 2019
December 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Inclination angle
Mean anterior cruciate ligament inclination angle in sagital x-ray (degree)
6 months
Secondary Outcomes (1)
post-operative complications
6 months
Study Arms (2)
Anterior cruciate ligament normal
PLACEBO COMPARATORnormal Anterior cruciate ligament reconstruction
Anterior cruciate ligament reconstruction
EXPERIMENTALAnterior cruciate ligament reconstruction and Position screw fixation
Interventions
Anterior cruciate ligament reconstruction (anterior screw fixation or posterior screw fixation)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ramathibodi Hospitallead
- Thammasat Universitycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
November 30, 2019
First Posted
December 6, 2019
Study Start
January 1, 2013
Primary Completion
December 1, 2018
Study Completion
December 1, 2019
Last Updated
December 6, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share