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AzTrials

Anterior Cruciate Ligament InjuriesALLRNCT06341192

Comparison Between Combined ALLR With Single Bundle and Double Bundle Anterior Cruciate Ligament Reconstruction

A study testing Single-bundle ACL combined anterolateral ligament reconstruction and Double-bundle ACL combined anterolateral ligament reconstruction in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Reconstruction, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to test and compare different surgical techniques in patients with anterior cruciate ligament (ACL) injuries. The main questions it aims to answer are: What are the optimal criteria for selecting between single-bundle ACL reconstruction combined with anterolateral ligament (ALL)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Single-bundle ACL combined anterolateral ligament reconstruction and Double-bundle ACL combined anterolateral 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
1 siteTaiwan
Study dates
26 Jun 2024to 31 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients plan to receive ACL surgery
  • at least 18 years old

Who cannot join

  • Presented history of the injured leg or congenital abnormality

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cheng-Pang Dr. Yang contact

886-3-3281200 ext. 2163

ronnie80097@gmail.com

Taiwan1 site, 1 recruiting

  • Chang Gung memorial hospital

    Taoyuan, taoyuan, 333

    Cheng-Pang Yang, Dr, ronnie80097@gmail.com

    Recruiting

Other trials in Taiwan

About this study

Official title: Clinical Comparison and Motion Analysis of Sports Function Between Combined Anterolateral Ligament Reconstruction With Single Bundle and Double Bundle Anterior Cruciate Ligament Reconstruction

The goal of this clinical trial is to test and compare different surgical techniques in patients with anterior cruciate ligament (ACL) injuries. The main questions it aims to answer are:

  • What are the optimal criteria for selecting between single-bundle ACL reconstruction combined with anterolateral ligament (ALL) reconstruction versus double-bundle ACL reconstruction combined with ALL reconstruction?
  • How do these two surgical techniques compare in terms of post-operative knee stability, functional outcomes, and reducing re-tear rates?
Read more

Participants will:

  • Undergo pre-operative MRI imaging, ligament stability testing, and motion analysis evaluations
  • Be randomly assigned to either:
  • Single-bundle ACL + ALL reconstruction
  • Double-bundle ACL + ALL reconstruction
  • Receive the assigned surgical procedure
  • Participate in post-operative follow-ups, ligament stability testing, and motion analysis at 6 months and 1 year

Researchers will compare the single-bundle ACL + ALL group and the double-bundle ACL + ALL group to see if one technique demonstrates superior knee stability, functional outcomes (e.g. return to sport ability), and lower ACL re-tear rates.

Read the detailed description

Anterolateral ligament(ALL) combined with anterior cruciate ligament reconstruction(ACL) has become more and more popular in recent years, as ALL could protect the ACL graft in tibial internal rotation, and prevent the ACL graft from rupture. Cottet et al. proposed a minimal invasive method with Y-figure construct of ALL, without acquiring additional graft from the patient. Their data showed significant lower graft re-rupture rate and faster return-to-sport(RTS). There are many different techniques of ACL combined ALL reconstruction. While these methods mostly are single bundle ACL combined ALL reconstruction. Previous cadaver studies told that the anterior cruciate ligament is composed of anteromedial and posterolateral bundle. It had been debated between single bundle and double bundle ACL reconstruction for years. As a result, it is meaningful to compare the clinical outcomes between ALL combined with single bundle or double bundle ACL reconstruction. Our studies included MRI image, arthrometer measurement and optical motion capture system. We hope to compare the clinical outcomes and sports function between A: single bundle ACL combined ALL reconstruction and B: double bundle ACL combined ALL reconstruction.

Being tested
Single-bundle ACL combined anterolateral ligament reconstruction, Double-bundle ACL combined anterolateral ligament reconstruction
Keywords
anterior cruciate ligament, anterolateral ligament, single bundle, double bundle, optical motion capture, graft rupture
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.

  • Single-bundle ACL combined anterolateral ligament reconstructionProcedure or surgery

    Single-Bundle ACL + ALL Reconstruction Group:

    Patients in this group will undergo reconstruction of the anterior cruciate ligament (ACL) using a single-bundle graft technique.

    In addition, they will have the anterolateral ligament (ALL) reconstructed using a portion of the same graft material.

    The single ACL bundle is typically positioned to replicate the anatomic footprint of the native ACL.

    For the ALL reconstruction, a commonly used technique is the Sonnery-Cottet ALL reconstruction using a gracilis tendon graft.

    This combines an intra-articular ACL reconstruction with an extra-articular lateral tenodesis to improve rotational instability.

  • Double-bundle ACL combined anterolateral ligament reconstructionProcedure or surgery

    Double-Bundle ACL + ALL Reconstruction Group:

    Patients in this group will undergo anatomic double-bundle ACL reconstruction using two graft bundles to more anatomically replicate the native ACL\'s anteromedial and posterolateral bundles.

    Like the single-bundle group, they will also have supplemental ALL reconstruction performed using a portion of the graft material.

    The double-bundle ACL reconstruction aims to better restore the ACL\'s complex anatomic footprint and bundles\' tension patterns.

Study groups in NCT06341192
Study groupRoleWhat they receive
Double bundle ACL combined anterolateral ligament reconstructionExperimentalACL reconstruction with triple folded semitendinosus and non folded gracilis and fibertape
Receives: Procedure: Double-bundle ACL combined anterolateral ligament reconstruction
Single bundle ACL combined anterolateral ligament reconstructionExperimentalSingle bundle ACL combined anterolateral ligament reconstruction
Receives: Procedure: Single-bundle ACL combined anterolateral ligament reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient-reported outcome measures (PROMs)

    International Knee Documentation Committee (IKDC) subjective score. The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

    Measured: Preoperative, 3 months, 6 months, 9 months, 1 year

  2. Patient-reported outcome measures (PROMs)

    Marx's activity score;The Marx Scale consists of four questions concerning four activities or actions: running, cutting, deceleration, and pivoting. The patient or survey respondent is asked to report on the frequency with which they performed the activity in their healthiest state within the past year. From 0 point(the worst) to 16 points(the best).

    Measured: Preoperative, 3 months, 6 months, 9 months, 1 year

  3. Patient-reported outcome measures (PROMs)

    SANE score, The Single Assessment Numeric Evaluation (SANE) is a patient rating from 0-100. Patients rate their current illness score in relation to their pre-injury baseline

    Measured: Preoperative, 3 months, 6 months, 9 months, 1 year

  4. Knee ligament stability:

    Anterior tibial translation measured using a ligament arthrometer (GNRB) to objectively quantify anteroposterior knee laxity

    Measured: Preoperative, 6 months, 1 year

  5. Knee ligament stability clinical evaluation

    Lachman test

    Measured: Preoperative, 6 months, 1 year

  6. Knee ligament stability clinical evaluation

    pivot shift test

    Measured: Preoperative, 6 months, 1 year

  7. Knee ligament stability clinical evaluation

    Anterior drawer test

    Measured: Preoperative, 6 months, 1 year

  8. Functional performance and return to sport

    Lower limb muscle strength

    Measured: Preoperative, 6 months, 1 year

  9. Functional performance and return to sport

    Lower limb symmetry index

    Measured: Preoperative, 6 months, 1 year

  10. Imaging

    Pre- and post-operative X-ray analysis to assess bone tunnels position

    Measured: Preoperative, 1 year

  11. Imaging

    Pre- and post-operative MRI analysis to assess graft ligamentization.

    Measured: Preoperative, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start26 Jun 2024
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Single-Bundle ACL + ALL Reconstruction Group: * Patients in this group will undergo reconstruction of the anterior cruciate ligament (ACL) using a single-bundle graft technique. * In addition, they will have the anterolateral ligament (ALL) reconstructed using a portion of the same graft material. * For the ALL reconstruction, a commonly used technique is the Sonnery-Cottet ALL reconstruction using a split graft. Double-Bundle ACL + ALL Reconstruction Group: * Patients in this group will undergo anatomic double-bundle ACL reconstruction using two graft bundles to more anatomically replicate the native ACL's anteromedial and posterolateral bundles. * Like the single-bundle group, they will also have supplemental ALL reconstruction performed using a portion of the graft material. * The double-bundle ACL reconstruction aims to better restore the ACL's complex anatomic footprint and bundles' tension patterns.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06341192
Sponsor's protocol ID
ChangGungMH ALL SB DB
Acronym
ALLR
Status last verified
Jan 2025
First submitted
18 Mar 2024
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 1. Protection of participant privacy and confidentiality is paramount in this study involving sensitive medical data and procedures. Sharing identifiable IPD could breach the trust and privacy of these patients undergoing knee surgeries. 2. The informed consent process likely did not explicitly state or obtain approval from participants to share their individual-level data, including medical images, functional assessments, and clinical outcomes, with third parties outside the research team.

Publications

  • Cameron KL, Peck KY, Davi SM, Owens CRBD, Svoboda CRSJ, DiStefano LJ, Marshall SW, de la Motte SJ, Beutler CRAI, Padua DA. Association Between Landing Error Scoring System (LESS) Items and the Incidence Rate of Lower Extremity Stress Fracture. Orthop J Sports Med. 2022 Jun 9;10(6):23259671221100790. doi: 10.1177/23259671221100790. eCollection 2022 Jun.

    PubMed 35706554

  • Helito CP, Helito PVP, Costa HP, Demange MK, Bordalo-Rodrigues M. Assessment of the Anterolateral Ligament of the Knee by Magnetic Resonance Imaging in Acute Injuries of the Anterior Cruciate Ligament. Arthroscopy. 2017 Jan;33(1):140-146. doi: 10.1016/j.arthro.2016.05.009. Epub 2016 Jun 17.

    PubMed 27324971

  • Sonnery-Cottet B, Thaunat M, Freychet B, Pupim BH, Murphy CG, Claes S. Outcome of a Combined Anterior Cruciate Ligament and Anterolateral Ligament Reconstruction Technique With a Minimum 2-Year Follow-up. Am J Sports Med. 2015 Jul;43(7):1598-605. doi: 10.1177/0363546515571571. Epub 2015 Mar 4.

    PubMed 25740835

  • Batty LM, Firth A, Moatshe G, Bryant DM, Heard M, McCormack RG, Rezansoff A, Peterson DC, Bardana D, MacDonald PB, Verdonk PCM, Spalding T, Getgood AMJ; STABILITY Study Group; Willits K, Birmingham T, Hewison C, Wanlin S, Firth A, Pinto R, Martindale A, O'Neill L, Jennings M, Daniluk M, Boyer D, Zomar M, Moon K, Pritchett R, Payne K, Fan B, Mohan B, Buchko GM, Hiemstra LA, Kerslake S, Tynedal J, Stranges G, Mcrae S, Gullett L, Brown H, Legary A, Longo A, Christian M, Ferguson C, Mohtadi N, Barber R, Chan D, Campbell C, Garven A, Pulsifer K, Mayer M, Simunovic N, Duong A, Robinson D, Levy D, Skelly M, Shanmugaraj A, Howells F, Tough M, Thompson P, Metcalfe A, Asplin L, Dube A, Clarkson L, Brown J, Bolsover A, Bradshaw C, Belgrove L, Millan F, Turner S, Verdugo S, Lowe J, Dunne D, McGowan K, Suddens CM, Declercq G, Vuylsteke K, Van Haver M. Association of Ligamentous Laxity, Male Sex, Chronicity, Meniscal Injury, and Posterior Tibial Slope With a High-Grade Preoperative Pivot Shift: A Post Hoc Analysis of the STABILITY Study. Orthop J Sports Med. 2021 Apr 6;9(4):23259671211000038. doi: 10.1177/23259671211000038. eCollection 2021 Apr.

    PubMed 33889648

  • Sonnery-Cottet B, Daggett M, Fayard JM, Ferretti A, Helito CP, Lind M, Monaco E, de Padua VBC, Thaunat M, Wilson A, Zaffagnini S, Zijl J, Claes S. Anterolateral Ligament Expert Group consensus paper on the management of internal rotation and instability of the anterior cruciate ligament - deficient knee. J Orthop Traumatol. 2017 Jun;18(2):91-106. doi: 10.1007/s10195-017-0449-8.

    PubMed 28220268

Questions about this trial

What is this clinical trial studying?

A study testing Single-bundle ACL combined anterolateral ligament reconstruction and Double-bundle ACL combined anterolateral ligament reconstruction in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Reconstruction, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

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 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: looking for participants now, as of the sponsor's last update on 25 Sep 2025. 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 Taiwan. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cheng-Pang Dr. Yang (886-3-3281200 ext. 2163, ronnie80097@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-reported outcome measures (PROMs) (time frame: Preoperative, 3 months, 6 months, 9 months, 1 year). The study lists 11 primary outcomes in all. 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 NCT06341192, 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 25 Sep 2025.

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