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Evaluation of Tibial and Femoral Tunnel Position After Arthroscopic Reconstruction of the Anterior Cruciate Ligament

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ClinicalTrials.gov Identifier: NCT01267435
Recruitment Status : Completed
First Posted : December 28, 2010
Last Update Posted : December 28, 2010
Sponsor:
Collaborator:
Shahid Beheshti University of Medical Sciences
Information provided by:
Isfahan University of Medical Sciences

Brief Summary:
The purpose of this study is to evaluate the accuracy of tunnel positions in anterior cruciate ligament reconstruction

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Rupture Procedure: Anterior cruciate ligament reconstruction Phase 2

Detailed Description:
The tunnel placement in ACL reconstruction is the most important predictor of clinical outcome and there is a high rate of inaccurate tunnel placements, even when performed by experienced surgeons.Tibial and femoral tunnel positions are one of the major concerns in anterior cruciate ligament reconstruction which have a great impact on the final surgical results

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Study of Evaluation of Tibial and Femoral Tunnel Position After ACL Reconstruction
Study Start Date : October 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
determining correct tunnel positions Procedure: Anterior cruciate ligament reconstruction
reconstruct the anterior cruciate ligament rupturing
Other Name: ACL reconstruction



Primary Outcome Measures :
  1. number of correct femoral tunnel position [ Time Frame: 5 min after operation ]
    we evalauted femoral tunnel positions


Secondary Outcome Measures :
  1. number of correct Tibial tunnel position [ Time Frame: 5 min after operation ]
    we evalauted tibial tunnel position



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • anterior cruciate ligament rupturing

Exclusion Criteria:


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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01267435


Locations
Iran, Islamic Republic of
Akhtar university hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Investigators
Study Chair: hamidreza shemshaki, MD research comittee

Additional Information:
Responsible Party: Dr. Alireza Yousefy/Associate Professor of Medical Education, Shaheed Beheshty University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01267435     History of Changes
Other Study ID Numbers: ASD-1213-8
First Posted: December 28, 2010    Key Record Dates
Last Update Posted: December 28, 2010
Last Verified: October 2008

Keywords provided by Isfahan University of Medical Sciences:
Arthroscopy, Anterior Cruciate Ligament, Tibial Tunnel.

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