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

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ClinicalTrials.gov Identifier: NCT01391650
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : May 23, 2012
Sponsor:
Collaborator:
Masaryk University
Information provided by (Responsible Party):
Komzak Martin, M.D., Hospital Znojmo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rupture of Anterior Cruciate Ligament Procedure: 'biomechanic of the knee' Not Applicable

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  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Rotational and Anteroposterior Stability of the Knee Joint After Single- and Double- Bundle ACL Reconstruction
Study Start Date : March 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


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 Name: replacement of ACL




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 53 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • isolated ACL lesion and primary ACL replacement

Exclusion Criteria:

  • replacement of ACL with navigation system

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391650


Locations
Czech Republic
Hospital Znojmo
Znojmo, Czech Republic, 66902
Sponsors and Collaborators
Hospital Znojmo
Masaryk University
Investigators
Principal Investigator: Martin Komzák Hospital Znojmo

Additional Information:
Responsible Party: Komzak Martin, M.D., proncipal investigator, Hospital Znojmo
ClinicalTrials.gov Identifier: NCT01391650     History of Changes
Other Study ID Numbers: DBVSB
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: May 23, 2012
Last Verified: May 2012

Keywords provided by Komzak Martin, M.D., Hospital Znojmo:
ACL
double-bundle
navigation system

Additional relevant MeSH terms:
Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries