ACL TearNCT06575543
CT Evaluation of ACL Anatomical Reconstruction
An observational study of ACL Tear, run by Assiut University at 1 site in Egypt.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- ACL Tear
- What is being tested?
- CT
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
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 .
Who may be able to join
- 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 .
Who cannot join
- 1- Age ( < 16 ) 2- Patient with multi ligamentous inj . 3- Revision ACL tear .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 .
Read the 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 ?
- Conditions
- ACL Tear
- Being tested
- CT
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| 2 portal group | The conventional 2-portal technique uses the anterolateral portal as the viewing portal and the anteromedial portal as the working portal Receives: Radiation: CT | |
| 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 Receives: Radiation: CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ct evaluation
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
Measured: 1 day after surgery
Secondary outcomes (1)
Clinical Examination &amp; Functional scores
- KOOS ( Knee Injury \&amp; 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.
Measured: at least 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ACL TearStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Almeldien Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575543
- Sponsor's protocol ID
- CT evaluation of ACL repair
- Status last verified
- Aug 2024
- First submitted
- 24 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 15476248Bedi 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.
PubMed 19801292van 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.
PubMed 20532865Nikolaou 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.
PubMed 19290508Snow 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.
PubMed 20140602
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical Transportal ACL Reconstruction : Effect of Using 2 or 3 Portal Technique on Femoral Tunnel Position
- ClinicalTrials.gov ID
- NCT06575543
- Acronym / sponsor ID
- CT evaluation of ACL repair
- Conditions
- ACL Tear
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 portal group | – | Radiation: CTThe conventional 2-portal technique uses the anterolateral portal as the viewing portal and the anteromedial portal as the working portal |
| 3 portal group | – | Radiation: CTthe 3-portal technique allows interchangeable use of the portals as a viewing and working portals depending on the specific task that is being performed |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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 .
Key inclusion criteria (3 listed)
- 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 .
Key exclusion criteria (1 listed)
- 1- Age ( < 16 ) 2- Patient with multi ligamentous inj . 3- Revision ACL tear .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT3D 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 | Radiation | 2 portal group, 3 portal group |
Primary outcome
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
1 secondary outcome
Clinical Examination &amp; Functional scores
Time frame: at least 2 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Background: PubMed 15476248Lohmander 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.
- Background: PubMed 19801292Bedi 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.
- Background: PubMed 20532865van 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.
- Background: PubMed 19290508Nikolaou 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.
- Background: PubMed 20140602Snow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL Tear, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Almeldien Mohamed, master degree (0884695376 ext. +201020567115, zalatawe@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ct evaluation (time frame: 1 day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06575543, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.