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

NCT ID: NCT06341192

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-26
• Study Completion Date: 2026-10-31

Brief 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) 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?

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.

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.

Conditions

Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Reconstruction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Double bundle ACL combined anterolateral ligament reconstruction

ACL reconstruction with triple folded semitendinosus and non folded gracilis and fibertape

Group Type: EXPERIMENTAL

Double-bundle ACL combined anterolateral ligament reconstruction

Intervention Type: PROCEDURE

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.

Single bundle ACL combined anterolateral ligament reconstruction

Single bundle ACL combined anterolateral ligament reconstruction

Group Type: EXPERIMENTAL

Single-bundle ACL combined anterolateral ligament reconstruction

Intervention Type: PROCEDURE

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.

Interventions

Single-bundle ACL combined anterolateral ligament reconstruction

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.

Intervention Type: PROCEDURE

Double-bundle ACL combined anterolateral ligament reconstruction

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Presented history of the injured leg or congenital abnormality

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheng-Pang Dr. Yang

Role: PRINCIPAL_INVESTIGATOR

Cheng Gung memorial hospital

Locations

Chang Gung memorial hospital

Taoyuan District, taoyuan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Cheng-Pang Dr. Yang

Role: CONTACT

ronnie80097@gmail.com

886-3-3281200 ext. 2163

Facility Contacts

Cheng-Pang Yang, Dr

Role: primary

ronnie80097@gmail.com

References

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.

Reference Type: BACKGROUND

PMID: 35706554 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27324971 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25740835 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33889648 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28220268 (View on PubMed)

Other Identifiers

ChangGungMH ALL SB DB

Identifier Type: -

Identifier Source: org_study_id