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OpenTrials
Completed

NCT Number: NCT04188704

Comparative Study of the Inclination Angle and Complications of Eccentric Grafts Position in ACL Reconstruction and Normal ACL: Retrospective Cohort

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.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interference screw

Procedure

Anterior cruciate ligament reconstruction (anterior screw fixation or posterior screw fixation)

Primary outcomes

  1. Inclination angle

    Time frame: 6 months

    Mean anterior cruciate ligament inclination angle in sagital x-ray (degree)

Secondary outcomes

  1. post-operative complications

    Time frame: 6 months

    number of participants with revision, infection, reflex sympathetic dystrophy and re-rupture

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Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Collaborators

  • Thammasat University

Registry information

Important dates

Study start
2013
Primary completion
2018
Study completion
2019
First posted
Dec 6, 2019
Registry last updated
Dec 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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