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

NCT ID: NCT01391650

Last Updated: 2012-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rupture of Anterior Cruciate Ligament

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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biomechanic of the knee

Group Type EXPERIMENTAL

'biomechanic of the knee'

Intervention Type PROCEDURE

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.

Interventions

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'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.

Intervention Type PROCEDURE

Other Intervention Names

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replacement of ACL

Eligibility Criteria

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Inclusion Criteria

* isolated ACL lesion and primary ACL replacement

Exclusion Criteria

* replacement of ACL with navigation system
Minimum Eligible Age

18 Years

Maximum Eligible Age

53 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Masaryk University

OTHER

Sponsor Role collaborator

Hospital Znojmo

OTHER

Sponsor Role lead

Responsible Party

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Komzak Martin, M.D.

proncipal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin Komzák

Role: PRINCIPAL_INVESTIGATOR

Hospital Znojmo

Locations

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Hospital Znojmo

Znojmo, Czech Republic, Czechia

Site Status

Countries

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Czechia

Related Links

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http://nemzn.cz

web page of investigator affiliation

Other Identifiers

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DBVSB

Identifier Type: -

Identifier Source: org_study_id

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