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

NCT06341192 | Recruiting DMC

• 1 other identifier: ChangGungMH ALL SB DB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Reconstruction

Keywords

anterior cruciate ligament; anterolateral ligament; single bundle; double bundle; optical motion capture; graft rupture

Outcome Measures

Primary Outcomes (11)

• 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).

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

• 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).

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

• 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

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

• Knee ligament stability:

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

  Preoperative, 6 months, 1 year

• Knee ligament stability clinical evaluation

  Lachman test

  Preoperative, 6 months, 1 year

• Knee ligament stability clinical evaluation

  pivot shift test

  Preoperative, 6 months, 1 year

• Knee ligament stability clinical evaluation

  Anterior drawer test

  Preoperative, 6 months, 1 year

• Functional performance and return to sport

  Lower limb muscle strength

  Preoperative, 6 months, 1 year

• Functional performance and return to sport

  Lower limb symmetry index

  Preoperative, 6 months, 1 year

• Imaging

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

  Preoperative, 1 year

• Imaging

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

  Preoperative, 1 year

Study Arms (2)

Double bundle ACL combined anterolateral ligament reconstruction

EXPERIMENTAL

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

Procedure: Double-bundle ACL combined anterolateral ligament reconstruction

Single bundle ACL combined anterolateral ligament reconstruction

EXPERIMENTAL

Single bundle ACL combined anterolateral ligament reconstruction

Procedure: Single-bundle ACL combined anterolateral ligament reconstruction

Interventions

Single-bundle ACL combined anterolateral ligament reconstruction 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.

Single bundle ACL combined anterolateral ligament reconstruction

Double-bundle ACL combined anterolateral ligament reconstruction 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.

Double bundle ACL combined anterolateral ligament reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Presented history of the injured leg or congenital abnormality

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung memorial hospital

Taoyuan District, taoyuan, 333, Taiwan

RECRUITING

Related Publications (5)

• 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.

  PMID: 35706554 BACKGROUND

• 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.

  PMID: 27324971 BACKGROUND

• 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.

  PMID: 25740835 BACKGROUND

• 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.

  PMID: 33889648 BACKGROUND

• 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.

  PMID: 28220268 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Cheng-Pang Dr. Yang

  Cheng Gung memorial hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng-Pang Dr. Yang

CONTACT

886-3-3281200 ext. 2163; ronnie80097@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: April 2, 2024
• Study Start: June 26, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)