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

Last updated: July 16, 2024
Sponsor: Ente Ospedaliero Cantonale, Bellinzona
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

ACL reconstruction preserving insertion

ACL reconstruction detaching insertion

Clinical Study ID

NCT03746470
ORL-ORT-003
  • Ages 16-60
  • All Genders

Study Summary

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 .

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: ACL reconstruction preserving insertion
Phase:
Study Start date:
October 22, 2018
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • IRCCS Istituto Ortopedico Rizzoli

    Bologna,
    Italy

    Active - Recruiting

  • EOC - Unità Traumatologia e Ortopedia ORL

    Lugano,
    Switzerland

    Active - Recruiting

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