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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
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   16 Years to 40 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01025895     History of Changes
Other Study ID Numbers: 144/09
Study First Received: December 3, 2009
Last Updated: December 3, 2009
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on June 17, 2013