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

December 4, 2019 updated by: Jatupon Kongtharvonskul, Ramathibodi Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Anterior cruciate ligament normal
normal Anterior cruciate ligament reconstruction
Procedure: Interference screw
Anterior cruciate ligament reconstruction (anterior screw fixation or posterior screw fixation)
Experimental: Anterior cruciate ligament reconstruction
Anterior cruciate ligament reconstruction and Position screw fixation
Procedure: Interference screw
Anterior cruciate ligament reconstruction (anterior screw fixation or posterior screw fixation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inclination angle
Time Frame: 6 months
Mean anterior cruciate ligament inclination angle in sagital x-ray (degree)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative complications
Time Frame: 6 months
number of participants with revision, infection, reflex sympathetic dystrophy and re-rupture
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Collaborators

Thammasat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

November 30, 2019

First Submitted That Met QC Criteria

December 4, 2019

First Posted (Actual)

December 6, 2019

Study Record Updates

Last Update Posted (Actual)

December 6, 2019

Last Update Submitted That Met QC Criteria

December 4, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-OT-1-182/60

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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