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

Rupture of Anterior Cruciate Ligament Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391650
• Other study ID #: DBVSB
• Status: Completed
• Phase: N/A
• First received: May 20, 2011
• Last updated: May 22, 2012
• Start date: March 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2012
• Source: Hospital Znojmo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 53 Years

Eligibility

Inclusion Criteria:

• isolated ACL lesion and primary ACL replacement

Exclusion Criteria:

• replacement of ACL with navigation system

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Rupture of Anterior Cruciate Ligament

Intervention

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.

Locations

Country	Name	City	State
Czech Republic	Hospital Znojmo	Znojmo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Znojmo	Masaryk University

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of rotational and anterior-posterior movement tibia to femur before the replacement of ACL	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	No
Secondary	measurement of rotational and anterior-posterior movement tibia to femur after the replacement of ACL	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	No

External Links

•   web page of investigator affiliation