Rupture of Anterior Cruciate LigamentNCT02754674
Comparison of Femoral Tunnel and Clinical Outcome Using Two Anterior Cruciate Ligament Reconstruction Techniques
A study testing type of anterior cruciate ligament reconstruction in people with Rupture of Anterior Cruciate Ligament, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
1. Purpose :To compare of femoral tunnel placement, tunnel geometry and clinical outcome using two anterior cruciate ligament reconstruction techniques ; transportal technique with flexible reamer and single bundle outside in technique with remnant preservation. 2. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament
- What is being tested?
- type of anterior cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Lachman test grade II,III and Pivot shift test grade II,III in physical examination
- ACL rupture in MRI
- Age 20~60
- within 6 months after trauma
Who cannot join
- osteoarthritis (OA) change in X-ray
- History of other ligament injury or ACL reconstruction in uninjured knee.
- operation history of either ipsilateral or contralateral knee(fracture, etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Femoral Tunnel Placement, Geometry and Clinical Outcome Using Two Anterior Cruciate Ligament Reconstruction Technique; Transportal Technique and Outside in Technique With Remnant Preservation. Prospective Randomized Trial
- Purpose :To compare of femoral tunnel placement, tunnel geometry and clinical outcome using two anterior cruciate ligament reconstruction techniques ; transportal technique with flexible reamer and single bundle outside in technique with remnant preservation.
- Subjects: anterior cruciate ligament (ACL) injury 66 patients
- Double bundle transportal technique with flexible reamer: 33
- Single bundle outside in technique with remnant preservation: 33
Read the detailed description
Anterior cruciate ligament (ACL) injury patients : Total 66
- Double bundle transportal technique with flexible reamer: 33
- Advantage: more normal ACL reconstruction than single bundle technique
- Disadvantage: to make the two bone tunnel must remove all the residual tissue.
- Single bundle outside in technique with remnant preservation: 33
- Advantage: good for being synovium and revascularization. Remained proprioception function helps to functional recovery.
- Disadvantage: difficult to ensure of visibility and tunnel drilling in the correct position because of remnant tissue.
- Conditions
- Rupture of Anterior Cruciate Ligament
- Being tested
- type of 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.
type of anterior cruciate ligament reconstructionProcedure or surgery
comparison of different types of anterior cruciate ligament reconstruction. transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation
| Study group | Role | What they receive |
|---|---|---|
| Transportal | Experimental | this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique Receives: Procedure: type of anterior cruciate ligament reconstruction |
| Outside in | Experimental | this is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with patients who underwent operation with outside in technique Receives: Procedure: type of anterior cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascularity of Graft Tendon
For evaluation of graft vascularity, quantitative parameter of area under the curve (AUC) was measured from DCE-MRI by using an image-processing software (IntelliSpace Portal, version 5.0; Philips Healthcare). A musculoskeletal radiologist manually drew the ROIs for intra-articular portion of the ACL graft including synovial membrane at the proximal, middle and distal zones. The software automatically generated time to signal intensity curves and then calculated the quantitative parameter, area under the time to signal intensity curve values, which were acquired by integrating the area under the time to signal intensity curve. To normalize the AUC (nAUC), we divided the AUC of medial gastrocnemius muscle into that of the ACL graft.
Measured: 1yr after surgery
Secondary outcomes (4)
Arthroscopy Grading
Graft continuity was graded as no tears, superficial tear (fibrillation or tear of superficial fibers), or substantial tear (rupture of 1 or more strands).
Graft tension was graded as taut, mild lax, and lax by probing at knee flexion and extension.
Synovial coverage of the grafts was graded as excellent (synovial coverage > 80% around graft), fair (coverage > 50%), or poor (coverage < 50%) On the second-look arthroscopic examination, graft continuity, graft tension, graft synovialization, and the presence of cyclops lesions were assessed by a senior surgeon.
Measured: 1yr after surgery
Clinical Knee Scoring
Lysholm score (ragne 0-100), HSS (hospital for special surgery) score (0-100) , IKDC (international knee doucomentation commitee) subjective score (0-100), Tegner activity scale (0-10).
All of scores demonstrated that higher score means a better outcomes.
Measured: 2 yr after surgery
Instability
The side-to-side difference was measured using a KT-200- arthrometer (MEDmetric) at 30 lb in 30° of knee flexion.
Measured: 2 yr after surgery
Graft Maturity (SNQ)
Measured: 1 yr 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 Apr 2016 (estimated)
- Study startMay 2014
- Primary completionMay 2014
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rupture of Anterior Cruciate LigamentStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joon Ho Wang, MD, Ph D, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02754674
- Sponsor's protocol ID
- SMC2013-07-097-001
- Status last verified
- Dec 2017
- First submitted
- 22 Feb 2015
- Last updated
- 20 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: if yes, age, sex, physical examination, trauma date, MRI.
Publications
Wang JH, Lee ES, Lee BH. Paradoxical tunnel enlargement after ACL reconstruction with hamstring autografts when using beta-TCP containing interference screws for tibial aperture fixation- prospectively comparative study. BMC Musculoskelet Disord. 2017 Sep 16;18(1):398. doi: 10.1186/s12891-017-1757-0.
PubMed 28915914
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Femoral Tunnel Placement, Geometry and Clinical Outcome Using Two Anterior Cruciate Ligament Reconstruction Technique; Transportal Technique and Outside in Technique With Remnant Preservation. Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT02754674
- Acronym / sponsor ID
- SMC2013-07-097-001
- Conditions
- Rupture of Anterior Cruciate Ligament
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Posted 20 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Purpose :To compare of femoral tunnel placement, tunnel geometry and clinical outcome using two anterior cruciate ligament reconstruction techniques ; transportal technique with flexible reamer and single bundle outside in technique with remnant preservation.
- Subjects: anterior cruciate ligament (ACL) injury 66 patients
- Double bundle transportal technique with flexible reamer: 33
- Single bundle outside in technique with remnant preservation: 33
Detailed description
Anterior cruciate ligament (ACL) injury patients : Total 66
- Double bundle transportal technique with flexible reamer: 33
- Advantage: more normal ACL reconstruction than single bundle technique
- Disadvantage: to make the two bone tunnel must remove all the residual tissue.
- Single bundle outside in technique with remnant preservation: 33
- Advantage: good for being synovium and revascularization. Remained proprioception function helps to functional recovery.
- Disadvantage: difficult to ensure of visibility and tunnel drilling in the correct position because of remnant tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transportal | Experimental | Procedure: type of anterior cruciate ligament reconstructionthis is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with transportal technique |
| Outside in | Experimental | Procedure: type of anterior cruciate ligament reconstructionthis is a type of anterior cruciate ligament reconstruction. this arm for patients who underwent operation with patients who underwent operation with outside in technique |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Lachman test grade II,III and Pivot shift test grade II,III in physical examination
- ACL rupture in MRI
- Age 20~60
- within 6 months after trauma
Key exclusion criteria (3 listed)
- osteoarthritis (OA) change in X-ray
- History of other ligament injury or ACL reconstruction in uninjured knee.
- operation history of either ipsilateral or contralateral knee(fracture, etc)
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 |
|---|---|---|
| type of anterior cruciate ligament reconstructioncomparison of different types of anterior cruciate ligament reconstruction. transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation | Procedure or surgery | Outside in, Transportal |
Primary outcome
Vascularity of Graft Tendon
Time frame: 1yr after surgery
For evaluation of graft vascularity, quantitative parameter of area under the curve (AUC) was measured from DCE-MRI by using an image-processing software (IntelliSpace Portal, version 5.0; Philips Healthcare). A musculoskeletal radiologist manually drew the ROIs for intra-articular portion of the ACL graft including synovial membrane at the proximal, middle and distal zones. The software automatically generated time to signal intensity curves and then calculated the quantitative parameter, area under the time to signal intensity curve values, which were acquired by integrating the area under the time to signal intensity curve. To normalize the AUC (nAUC), we divided the AUC of medial gastrocnemius muscle into that of the ACL graft.
4 secondary outcomes
Arthroscopy Grading
Time frame: 1yr after surgery
Clinical Knee Scoring
Time frame: 2 yr after surgery
Instability
Time frame: 2 yr after surgery
Graft Maturity (SNQ)
Time frame: 1 yr after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28915914Wang JH, Lee ES, Lee BH. Paradoxical tunnel enlargement after ACL reconstruction with hamstring autografts when using beta-TCP containing interference screws for tibial aperture fixation- prospectively comparative study. BMC Musculoskelet Disord. 2017 Sep 16;18(1):398. doi: 10.1186/s12891-017-1757-0.
- Individual participant dataSharing planned: No. if yes, age, sex, physical examination, trauma date, MRI.
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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.
Joon Ho Wang, MD, Ph D study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing type of anterior cruciate ligament reconstruction in people with Rupture of Anterior Cruciate Ligament, run by Samsung Medical Center 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 4 inclusion and 3 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 Dec 2019. 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?
Yes. Results are posted in the registry (first posted 20 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Vascularity of Graft Tendon (time frame: 1yr 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 NCT02754674, which also lists 1 linked publication.
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 Dec 2019.