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

Anterior Cruciate Ligament Tear Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01025895
• Other study ID #: 144/09
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 3, 2009
• Last updated: December 3, 2009
• Start date: January 2010
• Est. completion date: January 2013

Study information

• Verified date: July 2009
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2013
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 40 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Tear

Intervention

Procedure:
• acl reconstruction - double bundle technique

• acle reconstruction - single bundle technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.