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Anterior Cruciate Ligament (ACL) Reconstruction: Single Bundle Versus Double Bundle

NCT ID: NCT01025895

Last Updated: 2009-12-04

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-01-31

Brief Summary

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ACL tear is a common injury among athletes. The recommended treatment includes reconstruction of the ligament. The common reconstruction technique is single bundle reconstruction. However, this technique does not simulate the natural structure of the ligament. The purpose of the study is to compare between the common procedure, Single Bundle reconstruction with the Double Bundle reconstruction technique.

Detailed Description

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Conditions

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Anterior Cruciate Ligament Tear

Keywords

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arthroscopic surgical procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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single bundle

acl reconstruction - single bundle technique

Group Type ACTIVE_COMPARATOR

acle reconstruction - single bundle technique

Intervention Type PROCEDURE

double bundle

acl reconstruction - double bundle technique

Group Type EXPERIMENTAL

acl reconstruction - double bundle technique

Intervention Type PROCEDURE

Interventions

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acl reconstruction - double bundle technique

Intervention Type PROCEDURE

acle reconstruction - single bundle technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* knee instability with a history of ACL tear
* diagnosed ACL tear according to MRI
* age range 16-40.

Exclusion Criteria

* previous surgery in the knees
* multiple ligament raptures
* partial ACL tear
* severe cartilage degeneration
* genovaruse/genovalgus
* thin hamstrings tendons
* oper epiphysis in the knee joint
* patient with muscle/neurological problem that increases the tendency to fall
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Other Identifiers

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144/09

Identifier Type: -

Identifier Source: org_study_id