- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06575543
CT Evaluation of ACL Anatomical Reconstruction
August 29, 2024 updated by: Mostafa Almeldien Mohamed, Assiut University
Anatomical Transportal ACL Reconstruction : Effect of Using 2 or 3 Portal Technique on Femoral Tunnel Position
Our research is to evaluate the position and length of femoral tunnel, and to examine whether knee stability and clinical functional outcomes are better while using two-portal or three-portal technique .
Study Overview
Detailed Description
Arthroscopic anterior cruciate ligament (ACL) reconstruction is one of the most often performed orthopedic surgeries .
Restoration of normal anatomy after ACL reconstruction is related to achieve better function and a satisfactory long-term outcomes.
The principles for anatomical ACL reconstruction are to functionally reestablish the ACL to its native dimensions, collagen orientation and insertion sites .
The basis for the completion of these principles lies in the correct identification of the insertion sites.
The conventional 2-portal technique uses the anterolateral portal as the viewing portal and the anteromedial portal as the working portal.
the 3-portal technique allows interchangeable use of the portals as a viewing and working portals depending on the specific task that is being performed.
The internal joint anatomy, as soft tissue remnants and bony landmarks, should guide the placement of the portals in ACL anatomical reconstruction and that each of the portals has a specific role during ACL anatomical reconstruction .
So does the improved visualization through 3-portal technique compared to 2-portal technique have an impact on femoral tunnel position ?
Study Type
Observational
Enrollment (Estimated)
72
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mostafa Almeldien Mohamed, master degree
- Phone Number: +201020567115 0884695376
- Email: zalatawe@gmail.com
Study Contact Backup
- Name: Mohamed Ali Masoud, lecturer
- Phone Number: +201092698830
- Email: Masoud.ortho@aun.edu.eg
Study Locations
-
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Assiut, Egypt
- Assiut university
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Postoperative evaluation of patients who had previous ACL reconstruction (within terms of inclusion criteria & study sample ) by ct , clinical examination and functional scores .
Description
Inclusion Criteria:
- Age ( 16 - 50 ) .
- Isolated ACL tear with or without meniscal inj
- Patient who have undergone ACL reconstruction in the last 5 years in Arthroscopy and sports injuries unit .
Exclusion Criteria:
- 1- Age ( < 16 ) 2- Patient with multi ligamentous inj . 3- Revision ACL tear .
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
2 portal group
The conventional 2-portal technique uses the anterolateral portal as the viewing portal and the anteromedial portal as the working portal
|
3D CT scan have been used to evaluate the tunnels location after ACL reconstruction, as they can provide excellent perspective of the tunnel aperture, good visualization of bony structure and shape of the intercondylar notch, that preclude the use of a conventional 2-dimensional CT scan for measurement of the ACL tunnels location
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|
3 portal group
the 3-portal technique allows interchangeable use of the portals as a viewing and working portals depending on the specific task that is being performed
|
3D CT scan have been used to evaluate the tunnels location after ACL reconstruction, as they can provide excellent perspective of the tunnel aperture, good visualization of bony structure and shape of the intercondylar notch, that preclude the use of a conventional 2-dimensional CT scan for measurement of the ACL tunnels location
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Ct evaluation
Time Frame: 1 day after surgery
|
3D CT scan have been used to evaluate the tunnels location after ACL reconstruction, as they can provide excellent perspective of the tunnel aperture, good visualization of bony structure and shape of the intercondylar notch, that preclude the use of a conventional 2-dimensional CT scan for measurement of the ACL tunnels location
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1 day after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Examination & Functional scores
Time Frame: at least 2 years after surgery
|
- KOOS ( Knee Injury & Osteoarthritis Outcome ) The KOOS's five patient-relevant dimensions are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items).
A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included.
Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures.
Scores between 0 and 100 represent the percentage of total possible score achieved.
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at least 2 years after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lohmander LS, Ostenberg A, Englund M, Roos H. High prevalence of knee osteoarthritis, pain, and functional limitations in female soccer players twelve years after anterior cruciate ligament injury. Arthritis Rheum. 2004 Oct;50(10):3145-52. doi: 10.1002/art.20589.
- Bedi A, Altchek DW. The "footprint" anterior cruciate ligament technique: an anatomic approach to anterior cruciate ligament reconstruction. Arthroscopy. 2009 Oct;25(10):1128-38. doi: 10.1016/j.arthro.2009.03.008. Epub 2009 Aug 22.
- van Eck CF, Schreiber VM, Liu TT, Fu FH. The anatomic approach to primary, revision and augmentation anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2010 Sep;18(9):1154-63. doi: 10.1007/s00167-010-1191-4. Epub 2010 Jun 9.
- Nikolaou VS, Efstathopoulos N, Sourlas I, Pilichou A, Papachristou G. Anatomic double-bundle versus single-bundle ACL reconstruction: a comparative biomechanical study in rabbits. Knee Surg Sports Traumatol Arthrosc. 2009 Aug;17(8):895-906. doi: 10.1007/s00167-009-0754-8. Epub 2009 Mar 17.
- Snow M, Stanish WD. Double-bundle ACL reconstruction: how big is the learning curve? Knee Surg Sports Traumatol Arthrosc. 2010 Sep;18(9):1195-200. doi: 10.1007/s00167-010-1062-z. Epub 2010 Feb 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2024
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
October 1, 2025
Study Registration Dates
First Submitted
August 24, 2024
First Submitted That Met QC Criteria
August 26, 2024
First Posted (Actual)
August 28, 2024
Study Record Updates
Last Update Posted (Actual)
September 3, 2024
Last Update Submitted That Met QC Criteria
August 29, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT evaluation of ACL repair
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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