NCT01391650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

1.2 years

First QC Date

May 20, 2011

Last Update Submit

May 22, 2012

Conditions

Rupture of Anterior Cruciate Ligament

Keywords

ACLdouble-bundlenavigation system

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • measurement of rotational and anterior-posterior movement tibia to femur after the replacement of ACL

    one hour

Study Arms (1)

biomechanic of the knee

EXPERIMENTAL
Procedure: 'biomechanic of the knee'

Interventions

'biomechanic of the knee'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.

Also known as: replacement of ACL
biomechanic of the knee

Eligibility Criteria

Age18 Years - 53 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • isolated ACL lesion and primary ACL replacement

You may not qualify if:

  • replacement of ACL with navigation system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Znojmo

Znojmo, Czech Republic, 66902, Czechia

Location

Related Links

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Martin Komzák

    Hospital Znojmo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
proncipal investigator

Study Record Dates

First Submitted

May 20, 2011

First Posted

July 12, 2011

Study Start

March 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 23, 2012

Record last verified: 2012-05

Locations

CZ(1)