Back to resultsStability of the Knee Joint After Single and Double Bundle Anterior Cruciate Ligament Reconstruction
Primary Purpose
Rupture of Anterior Cruciate Ligament
Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
'biomechanic of the knee'
Sponsored by
About this trial
This is an interventional basic science trial for Rupture of Anterior Cruciate Ligament focused on measuring ACL, double-bundle, navigation system
Eligibility Criteria
Inclusion Criteria:
- isolated ACL lesion and primary ACL replacement
Exclusion Criteria:
- replacement of ACL with navigation system
Sites / Locations
- Hospital Znojmo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
biomechanic of the knee
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01391650
First Posted
May 20, 2011
Last Updated
May 22, 2012
Sponsor
Hospital Znojmo
Collaborators
Masaryk University
1. Study Identification
Unique Protocol Identification Number
NCT01391650
Brief Title
Stability of the Knee Joint After Single and Double Bundle Anterior Cruciate Ligament Reconstruction
Official Title
Rotational and Anteroposterior Stability of the Knee Joint After Single- and Double- Bundle ACL Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Znojmo
Collaborators
Masaryk University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of Anterior Cruciate Ligament
Keywords
ACL, double-bundle, navigation system
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
biomechanic of the knee
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
'biomechanic of the knee'
Other Intervention Name(s)
replacement of ACL
Intervention Description
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.
Primary Outcome Measure Information:
Title
measurement of rotational and anterior-posterior movement tibia to femur before the replacement of ACL
Description
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
Time Frame
one hour
Secondary Outcome Measure Information:
Title
measurement of rotational and anterior-posterior movement tibia to femur after the replacement of ACL
Description
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
Time Frame
one hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
53 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
isolated ACL lesion and primary ACL replacement
Exclusion Criteria:
replacement of ACL with navigation system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Komzák
Organizational Affiliation
Hospital Znojmo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Znojmo
City
Znojmo
ZIP/Postal Code
66902
Country
Czech Republic
12. IPD Sharing Statement
Links:
URL
http://nemzn.cz
Description
web page of investigator affiliation
Learn more about this trial
Stability of the Knee Joint After Single and Double Bundle Anterior Cruciate Ligament Reconstruction
We'll reach out to this number within 24 hrs