Back to resultsEvaluation of Tibial and Femoral Tunnel Position After Arthroscopic Reconstruction of the Anterior Cruciate Ligament
Primary Purpose
Anterior Cruciate Ligament Rupture
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Anterior cruciate ligament reconstruction
Sponsored by
About this trial
This is an interventional diagnostic trial for Anterior Cruciate Ligament Rupture focused on measuring Arthroscopy, Anterior Cruciate Ligament, Tibial Tunnel.
Eligibility Criteria
Inclusion Criteria:
- anterior cruciate ligament rupturing
Exclusion Criteria:
- none
Sites / Locations
- Akhtar university hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
determining correct tunnel positions
Arm Description
Outcomes
Primary Outcome Measures
number of correct femoral tunnel position
we evalauted femoral tunnel positions
Secondary Outcome Measures
number of correct Tibial tunnel position
we evalauted tibial tunnel position
Full Information
NCT ID
NCT01267435
First Posted
December 27, 2010
Last Updated
December 27, 2010
Sponsor
Isfahan University of Medical Sciences
Collaborators
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01267435
Brief Title
Evaluation of Tibial and Femoral Tunnel Position After Arthroscopic Reconstruction of the Anterior Cruciate Ligament
Official Title
Study of Evaluation of Tibial and Femoral Tunnel Position After ACL Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Isfahan University of Medical Sciences
Collaborators
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the accuracy of tunnel positions in anterior cruciate ligament reconstruction
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Rupture
Keywords
Arthroscopy, Anterior Cruciate Ligament, Tibial Tunnel.
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
determining correct tunnel positions
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Anterior cruciate ligament reconstruction
Other Intervention Name(s)
ACL reconstruction
Intervention Description
reconstruct the anterior cruciate ligament rupturing
Primary Outcome Measure Information:
Title
number of correct femoral tunnel position
Description
we evalauted femoral tunnel positions
Time Frame
5 min after operation
Secondary Outcome Measure Information:
Title
number of correct Tibial tunnel position
Description
we evalauted tibial tunnel position
Time Frame
5 min after operation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
anterior cruciate ligament rupturing
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hamidreza shemshaki, MD
Organizational Affiliation
research comittee
Official's Role
Study Chair
Facility Information:
Facility Name
Akhtar university hospital
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Links:
URL
http://www.sbmu.ac.ir
Description
Shaheed Beheshty university of medical sciences
Learn more about this trial
Evaluation of Tibial and Femoral Tunnel Position After Arthroscopic Reconstruction of the Anterior Cruciate Ligament
We'll reach out to this number within 24 hrs