A Study to Compare Two Techniques for the Reconstruction of the Anterior Cruciate Ligament

Ente Ospedaliero Cantonale, Bellinzona85 enrolled

Overview

This is a prospective and randomized trial to compare two different techniques used in normal practice for the reconstruction of the anterior cruciate ligament in arthroscopy. The experimental group (group 1) will undergo a reconstruction technique where semitendinosus and gracilis will preserve their insertion at the level of the hamstring whereas in the control group (group 2) the semitendinosus and gracilis tendons will be disengaged from their insertion on the hamstring .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Complete Tear, Knee, Anterior Cruciate Ligament

Interventions

ACL reconstruction preserving insertionPROCEDURE

Anterior cruciate ligament reconstruction with semitendinosus and gracilis, preserving their insertion at the level of the hamstring.

ACL reconstruction detaching insertionPROCEDURE

Anterior cruciate ligament reconstruction with semitendinosus and gracilis tendons completely detached from their insertion at the hamstring.

Eligibility

Sex: ALLMin age: 16 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 18 and 55 * MRI confirmed primary and total ACL injury of traumatic origin * Indication for ACL reconstruction in arthroscopy * Written informed consent * Active and non-sedentary lifestyle Exclusion Criteria: * Complex meniscal injuries * Cartilage lesions of sizes\> 2 cm2 * Other ligamentous lesions * Axis deviations greater than 10° * Rheumatic, neuromuscular or general systemic diseases * Prevention of injured knee traumas treated surgically * Difficulties in compliance in following the rehabilitation programs * Obesity (BMI ≥ 30) * Neoplastic diseases, metabolic diseases, inflammatory and systemic diseases, autoimmune diseases, immunocompromised patients

Locations (2)

IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy

EOC - Unità Traumatologia e Ortopedia ORL

Lugano, Switzerland

Outcomes

Primary Outcomes

Graft integration by the Signal / Noise Quotient (SNQ) at 6 months

Signal intensity of the graft evaluated by the Signal / Noise Quotient (SNQ) during MRI 3 Tesla

Time frame: 6 months after ACL reconstruction intervention

Secondary Outcomes

Graft integration by the Signal / Noise Quotient (SNQ) at 3 and 12 months

Signal intensity of the graft evaluated by the Signal / Noise Quotient (SNQ) during MRI 3 Tesla

Time frame: 3, 12 months after ACL reconstruction intervention

Right anatomical graft position

Evaluation of right anatomical graft position by MRI 3 TESLA

Time frame: 12 months after ACL reconstruction intervention

Anterior tibial translation

Anterior tibial translation will be measured in millimeters using the arthrometer Rolimeter

Time frame: 3, 6, 12 months after ACL reconstruction intervention

Anterior knee joint instability

Anterior knee joint instability will be measured by the device KiRA (Kinematic Rapid Assessment) by the parameters of the pivot-shift test

Time frame: 3, 6, 12 months after ACL reconstruction intervention

IKDC (International Knee Documentation Committee) questionnaire

Test to evaluate post-surgery instability with a scores range from 0 points to 100 points; patients report symptoms, sports and daily living activities

Time frame: 3, 6, 12 months after ACL reconstruction intervention

Tegner activity scale

Test to evaluate post-surgery instability with a scores range from 0 points to 10 points; patients describe their current level of activity and that before injury.

Data from ClinicalTrials.gov

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