Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction
NCT Number: NCT06505525
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anterior Cruciate Ligament Rupture|Ligament Knee Injury
Interventions: PROCEDURE: Extra-articular reconstruction with the Anterolateral Ligament
Sponsor: Federal University of São Paulo
Sex: ALL
Age: CHILD, ADULT
Enrollment: 146
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-08-01
Completion Date: 2027-06-01
Locations: Sao Paulo Hospital, São Paulo, Sao Paulo, 04024-002, Brazil|Parelheiros Hospital, São Paulo, Sao Paulo, 04883-290, Brazil

Summary:
Abstract

Introduction: Autologous hamstring tendons are the most commonly used grafts in ACL reconstruction worldwide. There are several ways to prepare the graft using these tendons. One can prioritize increasing the diameter of an isolated intra-articular graft or alternatively, using one graft limb as an extra-articular reinforcement via the anterolateral ligament (ALL) reconstruction, with both options aiming to reduce the re-rupture rate relative to traditional quadrupled hamstring grafts.

Objective: To compare, through a prospective and randomized clinical trial, intra and extra-articular ACL reconstruction with ALL using hamstring autograft versus isolated anatomical ACL reconstruction using quintuple or sextuple hamstring autograft.

Methods: 146 patients will be randomized into two groups of 20 patients. Patients included in the study will be evaluated preoperatively and after surgery at 3, 6, 9, 12, and 24 months postoperatively. The primary outcomes will be clinical failure rate and graft rerupture rate. Secondary outcomes will include functional capacity assessed through IKDC, Lysholm KOOS, and Tegner scores, pain using the VAS, as well as stability assessed by digital rolimeter and objective IKDC. Kinesiophobia and anxiety will be measured using the Tampa scale and Anxiety and Depression scale.

Keywords: Rupture, Anterior Cruciate Ligament, Anterior Cruciate Ligament Reconstruction

Primary Outcome Measures: Clinical failure rate, Persistence of pivot shift (grade 1 or higher) in more than one postoperative evaluation compared to the contralateral knee, or a grade 2 or higher pivot shift at any postoperative evaluation., Minimum 2 years|Graft rupture rate, Graft rupture will be defined as a graft tear confirmed by magnetic resonance imaging (MRI) or arthroscopy in the presence of any clinical failure criteria., Minimum 2 years
Secondary Outcome Measures: Functional capacity 1, Measured through the Subjective Knee Evaluation Form (IKDC) questionnaire, Minimum 2 years|Functional capacity 2, Measured through the Lysholm questionnaire, Minimum 2 years|Functional capacity 3, Measured through the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire, Minimum 2 years|Functional capacity 4, Measured through the Tegner questionnaire, Minimum 2 years|Stability 1, Measured using a digital rolimeter. Grafts will be classified as functional (side-to-side difference up to 3mm), partially functional (side-to-side difference between 3 and 6mm), and non-functional (side-to-side difference of 6mm or more), Minimum 2 years|Stability 2, Measured using Objective Knee Evaluation Form (IKDC) - Lachman test (grade of 0, 1, 2 and 3), Minimum 2 years|Stability 3, Measured using Objective Knee Evaluation Form (IKDC) - Pivot shift test (grade of 0, 1, 2 and 3), Minimum 2 years|Stability 4, Measured Objective Knee Evaluation Form (IKDC) - Anterior drawer test (grade of 0, 1, 2 and 3), Minimum 2 years|Kinesiophobia, Measured using the Tampa Scale, Minimum 2 years|Anxiety Scale, Measured using the Anxiety and Depression Scale, Minimum 2 years|Pain Scale, Measured using the Visual Analog Scale (VAS) - (score from 0 to 10 ), Minimum 2 years