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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01025895
First received: December 3, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

December 3, 2009
December 3, 2009
January 2010
January 2011   (final data collection date for primary outcome measure)
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. ]
Same as current
No Changes Posted
Not Provided
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Anterior Cruciate Ligament (ACL) Reconstruction: Single Bundle Versus Double Bundle
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Anterior Cruciate Ligament Tear
  • Procedure: acl reconstruction - double bundle technique
  • Procedure: acle reconstruction - single bundle technique
  • Active Comparator: single bundle
    acl reconstruction - single bundle technique
    Intervention: Procedure: acle reconstruction - single bundle technique
  • Experimental: double bundle
    acl reconstruction - double bundle technique
    Intervention: Procedure: acl reconstruction - double bundle technique
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
January 2013
January 2011   (final data collection date for primary outcome measure)

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
Both
16 Years to 40 Years
No
Not Provided
 
NCT01025895
144/09
Not Provided
Not Provided
Assaf-Harofeh Medical Center
Not Provided
Not Provided
Assaf-Harofeh Medical Center
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP