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

• Sponsor: Assaf-Harofeh Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01025895
• Collaborator: (none)
• Enrollment: 60
• Arms: 2
• Duration (Months): 36

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anterior Cruciate Ligament Tear	Procedure: acl reconstruction - double bundle technique; Procedure: acle reconstruction - single bundle technique	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2010
• Anticipated Primary Completion Date: Jan 1, 2011
• Anticipated Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: single bundle acl reconstruction - single bundle technique	Procedure: acle reconstruction - single bundle technique
Experimental: double bundle acl reconstruction - double bundle technique	Procedure: acl reconstruction - double bundle technique

Outcome Measures

Primary Outcome Measures

1. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assaf-Harofeh Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01025895
• Other Study ID Numbers: 144/09
• First Posted: Dec 4, 2009
• Last Update Posted: Dec 4, 2009
• Last Verified: Jul 1, 2009

• Keywords provided by , ,: arthroscopic surgical procedure
• Additional relevant MeSH terms: Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of Dec 4, 2009