Stability of the Knee Joint After Single and Double Bundle Anterior Cruciate Ligament Reconstruction

May 22, 2012 updated by: Komzak Martin, M.D., Hospital Znojmo

Rotational and Anteroposterior Stability of the Knee Joint After Single- and Double- Bundle ACL Reconstruction

The purpose of this prospective study is to evaluate the influence of both bundles on the knee stability - anterior-posterior translation, internal and external rotations after the double-bundle reconstruction of Anterior Cruciate Ligament and to compare the stability after single-bundle and double-bundle reconstruction using a computer navigation system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this prospective study is to evaluate the influence of both bundles on the knee stability - anterior-posterior translation, internal and external rotations after the double-bundle reconstruction of Anterior Cruciate Ligament (ACL) and to compare the stability after single-bundle and double-bundle reconstruction using a computer navigation system.

Methods Anterior-posterior translation, internal rotation, and external rotation were recorded in the deficient condition (without ACL), in the anteromedial-reconstructed, posterolateral-reconstructed, and in the whole ACL-reconstructed condition for double-bundle reconstructions and before and after the ACL reconstruction in single-bundle group. KT-1000 was used to evaluate anterior-posterior translation.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • isolated ACL lesion and primary ACL replacement

Exclusion Criteria:

  • replacement of ACL with navigation system

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: biomechanic of the knee
Procedure: 'biomechanic of the knee'
20 patients had their ACL replaced by SB reconstruction from hamstrings, 20 patients double - bundle technique with AM bundle being reconstructed first, and 20 patients with the PL bundle first.
Other Names:
  • replacement of ACL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of rotational and anterior-posterior movement tibia to femur before the replacement of ACL
Time Frame: one hour
measurement of rotational and anterior-posterior movement tibia to femur before the replacement the ACL (single bundle)or after the tonisation of one portion of ACL in double bundle type of reconstruction of ACL in the operating sale
one hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measurement of rotational and anterior-posterior movement tibia to femur after the replacement of ACL
Time Frame: one hour
measurement of rotational and anterior-posterior movement tibia to femur after the replacement the ACL (single bundle)or after the tonisation of second portion of ACL in double bundle type of reconstruction of ACL in the operating sale
one hour

Collaborators and Investigators

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

Sponsor

Hospital Znojmo

Collaborators

Masaryk University

Investigators

  • Principal Investigator: Martin Komzák, Hospital Znojmo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

March 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

May 20, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Estimate)

May 23, 2012

Last Update Submitted That Met QC Criteria

May 22, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DBVSB

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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