Comparison Between Combined ALLR With Single Bundle and Double Bundle Anterior Cruciate Ligament Reconstruction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChang Gung Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients plan to receive ACL surgery
at least 18 years old
Disqualifiers
Presented history of the injured leg or congenital abnormality
Trial design
Design model
Parallel
Treatments tested in this trial
Single-bundle ACL combined anterolateral ligament reconstruction
Procedure/SurgerySingle-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 reconstruction
Procedure/SurgeryDouble-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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Double bundle ACL combined anterolateral ligament reconstructionExperimental treatment 1 intervention
Group B: Single bundle ACL combined anterolateral ligament reconstructionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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).
Time frame
Preoperative, 3 months, 6 months, 9 months, 1 year2
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).
Time frame
Preoperative, 3 months, 6 months, 9 months, 1 year3
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
Time frame
Preoperative, 3 months, 6 months, 9 months, 1 year4
Knee ligament stability:
Anterior tibial translation measured using a ligament arthrometer (GNRB) to objectively quantify anteroposterior knee laxity
Time frame
Preoperative, 6 months, 1 yearSponsors and contacts
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Source ClinicalTrials.gov