MedTrace Logo

Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction

NCT06505525 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-04-03

No results posted yet for this study

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 73 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

Conditions

  • Anterior Cruciate Ligament Rupture
  • Ligament Knee Injury

Interventions

PROCEDURE

Extra-articular reconstruction with the Anterolateral Ligament

Anatomical ACL reconstruction combined with extra-articular reconstruction with the Anterolateral Ligament

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • MARCOS VINICIUS CREDIDIO · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2026-12-31
Completion
2027-06-01

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06505525 on ClinicalTrials.gov