RecruitingNot ApplicableNCT06505525

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

Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction: Prospective Multicenter Randomized Clinical Trial With Hamstring Autograft


Sponsor

Federal University of São Paulo

Enrollment

146 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 14 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Extra-articular reconstruction with the Anterolateral Ligament for people with anterior cruciate ligament rupture and ligament knee injury. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREExtra-articular reconstruction with the Anterolateral Ligament

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


Locations(2)

Sao Paulo Hospital

São Paulo, São Paulo, Brazil

Parelheiros Hospital

São Paulo, São Paulo, Brazil

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NCT06505525


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