Anterior Cruciate Ligament RuptureNCT01513434
Femoral Tunnel Position on Conventional MRI After Anterior Cruciate Ligament Reconstruction-Transtibial Technique Versus Transportal Technique
A study testing transtibial technique, Transportal technique and anterior cruciate ligament reconstruction in people with Anterior Cruciate Ligament Rupture, run by National Police Hospital at 1 site in South Korea.
Trial summary
The position of the femoral tunnel in anterior cruciate ligament (ACL) reconstruction has been assessed on three dimensional CT (3D-CT) scan or in cadaveric study. However, these methods have some issues; 3D-CT scan has a concern on radiation exposure and cadaveric study is not easily available nor an in vivo test. Read more about this study
- Who is it for?
- Ages 17 to 45 years, men only
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- transtibial technique, Transportal technique and anterior cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2008to Nov 2011
- Phase
- Interventional
- 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 17 to 45 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis of anterior cruciate ligament rupture
Who cannot join
- female
- over 45 years old
- the subjects who had ACL reconstruction with graft other than Achilles allograft
- the subjects who had concomitant other ligament injuries on the same knee needing surgical treatment
- revision ACL reconstruction
- double bundle ACL reconstruction
- concomitant full thickness cartilage injury needing cartilage repairing surgery
Trial locations and contacts
1 site in 1 country.
About this study
The position of the femoral tunnel in anterior cruciate ligament (ACL) reconstruction has been assessed on three dimensional CT (3D-CT) scan or in cadaveric study. However, these methods have some issues; 3D-CT scan has a concern on radiation exposure and cadaveric study is not easily available nor an in vivo test. The purpose of this study is to compare the position of the femoral tunnel aperture on conventional MRI and the outcomes after single bundle ACL reconstruction using free tendon Achilles allograft between transportal technique and transtibial technique in active young men.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- transtibial technique, Transportal technique, anterior cruciate ligament reconstruction
- 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.
transtibial techniqueProcedure or surgery
Femoral tunnel was made via tibial tunnel in anterior cruciate ligament reconstruction.
Transportal techniqueProcedure or surgery
Also called anteromedial portal technique
Femoral tunnel was made via anteromedial portal in anterior cruciate ligament reconstruction.
anterior cruciate ligament reconstructionProcedure or surgery
femoral and tibial tunneling graft fixation on the femoral side with endobutton and on the tibial side with post-tie and interference screw
| Study group | Role | What they receive |
|---|---|---|
| transtibial technique | Active comparator | In anterior cruciate ligament reconstruction, femoral tunnel was made via tibial tunnel. Receives: Procedure: transtibial technique; Procedure: anterior cruciate ligament reconstruction |
| Transportal technique | Active comparator | In anterior cruciate ligament reconstruction, femoral tunnel was made via anteromedial portal. Receives: Procedure: Transportal technique; Procedure: anterior cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lysholm score
Lysholm score was superior in transportal technique to transtibial technique.
Measured: at least two years after surgery
Position of femoral tunnel aperture
The position of the femoral tunnel aperture with transportal technique was more posterior than that of transtibial technique.
Measured: within one week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJul 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Police Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jung Ho Noh, National Police Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513434
- Sponsor's protocol ID
- NPH2008-004
- Status last verified
- Jan 2012
- First submitted
- 16 Jan 2012
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Tunnel Position on Conventional MRI After Anterior Cruciate Ligament Reconstruction-Transtibial Technique Versus Transportal Technique
- ClinicalTrials.gov ID
- NCT01513434
- Acronym / sponsor ID
- NPH2008-004
- Conditions
- Anterior Cruciate Ligament Rupture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- National Police HospitalOther government
- Study start
- Jul 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 20 Jan 2012 (estimated)
- 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.
The position of the femoral tunnel in anterior cruciate ligament (ACL) reconstruction has been assessed on three dimensional CT (3D-CT) scan or in cadaveric study. However, these methods have some issues; 3D-CT scan has a concern on radiation exposure and cadaveric study is not easily available nor an in vivo test. The purpose of this study is to compare the position of the femoral tunnel aperture on conventional MRI and the outcomes after single bundle ACL reconstruction using free tendon Achilles allograft between transportal technique and transtibial technique in active young men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transtibial technique | Active comparator | Procedure: transtibial technique, Procedure: anterior cruciate ligament reconstructionIn anterior cruciate ligament reconstruction, femoral tunnel was made via tibial tunnel. |
| Transportal technique | Active comparator | Procedure: Transportal technique, Procedure: anterior cruciate ligament reconstructionIn anterior cruciate ligament reconstruction, femoral tunnel was made via anteromedial portal. |
Who may qualify
- Ages
- 17 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- diagnosis of anterior cruciate ligament rupture
Key exclusion criteria (7 listed)
- female
- over 45 years old
- the subjects who had ACL reconstruction with graft other than Achilles allograft
- the subjects who had concomitant other ligament injuries on the same knee needing surgical treatment
- revision ACL reconstruction
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 |
|---|---|---|
| transtibial techniqueFemoral tunnel was made via tibial tunnel in anterior cruciate ligament reconstruction. | Procedure or surgery | transtibial technique |
| Transportal techniqueAlso: anteromedial portal techniqueFemoral tunnel was made via anteromedial portal in anterior cruciate ligament reconstruction. | Procedure or surgery | Transportal technique |
| anterior cruciate ligament reconstructionfemoral and tibial tunneling graft fixation on the femoral side with endobutton and on the tibial side with post-tie and interference screw | Procedure or surgery | Transportal technique, transtibial technique |
Primary outcome
Lysholm score
Time frame: at least two years after surgery
Lysholm score was superior in transportal technique to transtibial technique.
Position of femoral tunnel aperture
Time frame: within one week after surgery
The position of the femoral tunnel aperture with transportal technique was more posterior than that of transtibial technique.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transtibial technique, Transportal technique and anterior cruciate ligament reconstruction in people with Anterior Cruciate Ligament Rupture, run by National Police Hospital at 1 site in South Korea.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 20 Jan 2012. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm score (time frame: at least two years after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2012; AzTrials last refreshed its copy on 8 Nov 2026.