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

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ClinicalTrials.gov Identifier: NCT01025895
Recruitment Status : Unknown
Verified July 2009 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 4, 2009
Last Update Posted : December 4, 2009
Sponsor:
Information provided by:

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Study Start Date : January 2010
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 [ 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. ]

Eligibility Criteria

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
Criteria

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
More Information

ClinicalTrials.gov Identifier: NCT01025895     History of Changes
Other Study ID Numbers: 144/09
First Posted: December 4, 2009    Key Record Dates
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