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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
ClinicalTrials.gov Identifier:
First Posted: December 4, 2009
Last Update Posted: December 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
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 Intervention Phase
Anterior Cruciate Ligament Tear Procedure: acl reconstruction - double bundle technique Procedure: acle reconstruction - single bundle technique Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • WOMAC, VAS, SF-36, Lisholm, Knee society score, isokinetic muscle strength testing, Single HOP test , Tripple Hop Test [ Time Frame: 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. ]

Estimated Enrollment: 60
Study Start Date: January 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
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
No Contacts or Locations Provided
  More Information

ClinicalTrials.gov Identifier: NCT01025895     History of Changes
Other Study ID Numbers: 144/09
First Submitted: December 3, 2009
First Posted: December 4, 2009
Last Update Posted: December 4, 2009
Last Verified: July 2009

Keywords provided by Assaf-Harofeh Medical Center:
arthroscopic surgical procedure

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries