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Completed

NCT Number: NCT03746470

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

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 .

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Key information

Conditions

Complete Tear, Knee, Anterior Cruciate Ligament

Age range

16 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACL reconstruction preserving insertion

Procedure

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

ACL reconstruction detaching insertion

Procedure

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

Primary outcomes

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

    Time frame: 6 months after ACL reconstruction intervention

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

Secondary outcomes

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

    Time frame: 3, 12 months after ACL reconstruction intervention

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

  2. Right anatomical graft position

    Time frame: 12 months after ACL reconstruction intervention

    Evaluation of right anatomical graft position by MRI 3 TESLA

  3. Anterior tibial translation

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

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

  4. Anterior knee joint instability

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

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

  5. IKDC (International Knee Documentation Committee) questionnaire

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

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

  6. Tegner activity scale

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

    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.

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Other

Collaborators

  • Clinical Trial Unit Ente Ospedaliero Cantonale

Registry information

Official study title

A Randomized Controlled Trial to Evaluate the Graft Ligamentization and Integration in the Reconstruction of the Anterior Cruciate Ligament With or Without Detachment of Hamstring Tendon Tibial Insertion

Acronym: ACL

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Nov 19, 2018
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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