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

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ClinicalTrials.gov Identifier: NCT03746470
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : October 6, 2021
Sponsor:
Collaborator:
Clinical Trial Unit Ente Ospedaliero Cantonale
Information provided by (Responsible Party):
Marco Delcogliano, Ente Ospedaliero Cantonale, Bellinzona

Study Description
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Brief 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 .


Condition or disease Intervention/treatment Phase
Complete Tear, Knee, Anterior Cruciate Ligament Procedure: ACL reconstruction preserving insertion Procedure: ACL reconstruction detaching insertion Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: insertion preserving
ACL reconstruction preserving insertion
 Procedure: ACL reconstruction preserving insertion
Anterior cruciate ligament reconstruction with semitendinosus and gracilis, preserving their insertion at the level of the hamstring.
Active Comparator: insertion detaching
ACL reconstruction detaching insertion
 Procedure: ACL reconstruction detaching insertion
Anterior cruciate ligament reconstruction with semitendinosus and gracilis tendons completely detached from their insertion at the hamstring.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746470


Contacts
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Contact: Marco Decogliano, MD +41918117029 RicercaOrtopedia.ORL@eoc.ch

Locations
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Italy
IRCCS Istituto Ortopedico Rizzoli Recruiting
Bologna, Italy
Contact: Francesco Perdisa, MD         
Switzerland
EOC - Unità Traumatologia e Ortopedia ORL Recruiting
Lugano, Switzerland
Contact: Marco Decogliano, MD       RicercaOrtopedia.ORL@eoc.ch   
Sponsors and Collaborators
Marco Delcogliano
Clinical Trial Unit Ente Ospedaliero Cantonale
Investigators
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Study Chair: Marco Decogliano, MD EOC - Unità Traumatologia e Ortopedia - ORL
More Information
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Responsible Party: Marco Delcogliano, Sponsor Investigator, Ente Ospedaliero Cantonale, Bellinzona
ClinicalTrials.gov Identifier: NCT03746470    
Other Study ID Numbers: ORL-ORT-003
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marco Delcogliano, Ente Ospedaliero Cantonale, Bellinzona:
arthroscopy