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

Phase 4

• Conditions: Anterior Cruciate Ligament Tear
• Interventions: Procedure: acle reconstruction - single bundle technique; Procedure: acl reconstruction - double bundle technique

• Registration Number: NCT01025895
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2009-07
• Study First Submitted: 2009-12-03
• Study First Submitted QC: 2009-12-03
• Last Update Submitted: 2009-12-03
• Study First Posted: 2009-12-04
• Last Update Posted: 2009-12-04
• Study Start: 2010-01
• Primary Completion: 2011-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single bundle	acle reconstruction - single bundle technique	acl reconstruction - single bundle technique
double bundle	acl reconstruction - double bundle technique	acl reconstruction - double bundle technique

Primary Outcome Measures

Name	Time	Method
WOMAC, VAS, SF-36, Lisholm, Knee society score, isokinetic muscle strength testing, Single HOP test , Tripple Hop Test	pre-op. 1 day post op., 7-14 days post op., 6 weeks post op., 12 weeks post op., 26 weeks post op., 1 year post op., 2 years post op.