Anterior Cruciate Ligament RuptureNCT02555917
Comparison of Remnant Preserving Versus Remnant Resecting Anterior Cruciate Ligament Reconstruction
A study testing anterior cruciate ligament reconstruction in people with Anterior Cruciate Ligament Rupture, run by The Catholic University of Korea.
Trial summary
Anterior cruciate ligament injury is very common knee injury. Especially Anterior cruciate ligament complete rupture leads to knee joint instability and degenerative change of the knee. Anterior cruciate ligament reconstruction is performed for resolving these problems and it gives excellent results. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- anterior cruciate ligament reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Sep 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 19 years old
- patients for ACL reconstruction having medicare insurance
Who cannot join
- infection
- previous surgery experience
- progressive osteoarthritis
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Tibia and Femoral Tunnel Location Comparison of Remnant Preserving Versus Remnant Resecting Anterior Cruciate Ligament Reconstruction
Anterior cruciate ligament injury is very common knee injury. Especially Anterior cruciate ligament complete rupture leads to knee joint instability and degenerative change of the knee. Anterior cruciate ligament reconstruction is performed for resolving these problems and it gives excellent results. For leading to successful result of anterior cruciate ligament reconstruction, selecting of appropriate femoral tunnel and tibial tunnel is necessary. If selecting inappropriate tibial tunnel location makes pain, synovitis, impingement of transplanted tendon, loss of range of motion, instability, failure of transplantation and risk of arthritis. It is known that selection of inappropriate tibial tunnel location is the most common cause of anterior cruciate ligament reconstruction failure.
Recently many studies reconstructed at anatomical lesion instead of isometric point. And some cadaver studies reported that tibial insertion of anterior cruciate ligament has "C" shape. There are two methods for anterior cruciate ligament reconstruction. One is preserving remnant and the other is removing remnant.
This study aims to compare the tibia and femoral tunnel location of remnant preserving and remnant resecting anterior cruciate ligament reconstruction.
Read the detailed description
The study design is a double-blind randomized controlled trial. Randomly, twenty patients planed to undergo anterior cruciate ligament reconstruction using autograft by remnant preserving and other twenty patients undergo anterior cruciate ligament reconstruction using autograft by resecting anterior cruciate ligament. The clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and 1years. And clinical score consists of Visual Analog Score, lachman test, anterior laxity, Lysholm knee score, international knee documentation committee score. Femoral and tibial tunnel location will be analyzed by three-dimensional computed tomography using Bernard quadrant method after surgery.
The present study aimed to determine and compare (1) the accuracy of tibia and femoral tunnel location and (2) postoperative functional outcome after anterior cruciate ligament reconstruction between remnant preserving group versus remnant resecting group.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- 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.
anterior cruciate ligament reconstructionProcedure or surgery
Twenty patients planed to undergo anterior cruciate ligament reconstruction by preserving remnant and other twenty patients undergo anterior cruciate ligament reconstruction by preserving remnant.
| Study group | Role | What they receive |
|---|---|---|
| Remnant preserving | Experimental | Anterior cruciate ligament reconstruction:
anterior cruciate ligament remnant will be preserved in the operation Receives: Procedure: anterior cruciate ligament reconstruction |
| Remnant resecting | Active comparator | Anterior cruciate ligament reconstruction:
anterior cruciate ligament remnant will be removed in the operation Receives: Procedure: anterior cruciate ligament reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bernard quadrant method using 3-dimensional computed tomography for the femoral and tibial tunnel location
The locations of the tunnels will be quantified and presented as the percentage distance from the deepest subchondral contour and the intercondylar notch roof to the center of the tunnel by use of the Bernard quadrant method.
Measured: 1 week after surgery
Secondary outcomes (4)
Knee Laxity Testing Device(KT1000) for amount of increased anterior knee translation
If increased translation, 3 mm or more will be checked compared to the normal contralateral knee.
Measured: 6weeks, 3months, 6months and 1years after surgery
Visual Analog Score for pain
Scores range from 0 [no pain] to 10 [worst possible pain].
Measured: 6weeks, 3months, 6months and 1years after surgery
Lysholm knee score for functional outcome
Scores range from 0 [worst possible function] to 100 [normal function].
Measured: 6weeks, 3months, 6months and 1years after surgery
International Knee Documentation Committee Score for functional outcome
Scores range from 0 [worst possible function] to 100 [normal function].
Measured: 6weeks, 3months, 6months and 1years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2017 (estimated)
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong In, The Catholic University of Korea
- Investigators
- Yong In, MD, PhD, Study chair, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555917
- Sponsor's protocol ID
- ACL reconstruction
- Status last verified
- Sep 2015
- First submitted
- 29 Aug 2015
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tibia and Femoral Tunnel Location Comparison of Remnant Preserving Versus Remnant Resecting Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT02555917
- Acronym / sponsor ID
- ACL reconstruction
- Conditions
- Anterior Cruciate Ligament Rupture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 22 Sep 2015 (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.
Anterior cruciate ligament injury is very common knee injury. Especially Anterior cruciate ligament complete rupture leads to knee joint instability and degenerative change of the knee. Anterior cruciate ligament reconstruction is performed for resolving these problems and it gives excellent results. For leading to successful result of anterior cruciate ligament reconstruction, selecting of appropriate femoral tunnel and tibial tunnel is necessary. If selecting inappropriate tibial tunnel location makes pain, synovitis, impingement of transplanted tendon, loss of range of motion, instability, failure of transplantation and risk of arthritis. It is known that selection of inappropriate tibial tunnel location is the most common cause of anterior cruciate ligament reconstruction failure.
Recently many studies reconstructed at anatomical lesion instead of isometric point. And some cadaver studies reported that tibial insertion of anterior cruciate ligament has "C" shape. There are two methods for anterior cruciate ligament reconstruction. One is preserving remnant and the other is removing remnant.
This study aims to compare the tibia and femoral tunnel location of remnant preserving and remnant resecting anterior cruciate ligament reconstruction.
Detailed description
The study design is a double-blind randomized controlled trial. Randomly, twenty patients planed to undergo anterior cruciate ligament reconstruction using autograft by remnant preserving and other twenty patients undergo anterior cruciate ligament reconstruction using autograft by resecting anterior cruciate ligament. The clinical outcome is comparative preoperative, postoperative 6weeks, 3months, 6months and 1years. And clinical score consists of Visual Analog Score, lachman test, anterior laxity, Lysholm knee score, international knee documentation committee score. Femoral and tibial tunnel location will be analyzed by three-dimensional computed tomography using Bernard quadrant method after surgery.
The present study aimed to determine and compare (1) the accuracy of tibia and femoral tunnel location and (2) postoperative functional outcome after anterior cruciate ligament reconstruction between remnant preserving group versus remnant resecting group.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remnant preserving | Experimental | Procedure: anterior cruciate ligament reconstructionAnterior cruciate ligament reconstruction: anterior cruciate ligament remnant will be preserved in the operation |
| Remnant resecting | Active comparator | Procedure: anterior cruciate ligament reconstructionAnterior cruciate ligament reconstruction: anterior cruciate ligament remnant will be removed in the operation |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 19 years old
- patients for ACL reconstruction having medicare insurance
Key exclusion criteria (3 listed)
- infection
- previous surgery experience
- progressive osteoarthritis
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 |
|---|---|---|
| anterior cruciate ligament reconstructionTwenty patients planed to undergo anterior cruciate ligament reconstruction by preserving remnant and other twenty patients undergo anterior cruciate ligament reconstruction by preserving remnant. | Procedure or surgery | Remnant preserving, Remnant resecting |
Primary outcome
Bernard quadrant method using 3-dimensional computed tomography for the femoral and tibial tunnel location
Time frame: 1 week after surgery
The locations of the tunnels will be quantified and presented as the percentage distance from the deepest subchondral contour and the intercondylar notch roof to the center of the tunnel by use of the Bernard quadrant method.
4 secondary outcomes
Knee Laxity Testing Device(KT1000) for amount of increased anterior knee translation
Time frame: 6weeks, 3months, 6months and 1years after surgery
Visual Analog Score for pain
Time frame: 6weeks, 3months, 6months and 1years after surgery
Lysholm knee score for functional outcome
Time frame: 6weeks, 3months, 6months and 1years after surgery
International Knee Documentation Committee Score for functional outcome
Time frame: 6weeks, 3months, 6months and 1years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
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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.
Yong In, MD, PhD study chair
The Catholic University of Korea
Questions about this trial
What is this clinical trial studying?
A study testing anterior cruciate ligament reconstruction in people with Anterior Cruciate Ligament Rupture, run by The Catholic University of 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 2 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: status not confirmed, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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 Yong In, MD, PhD (8290445228, iy1000@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bernard quadrant method using 3-dimensional computed tomography for the femoral and tibial tunnel location (time frame: 1 week after surgery). 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 22 Sep 2015.