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

December 20, 2023 updated by: Ente Ospedaliero Cantonale, Bellinzona

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

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 Overview

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Bologna, Italy
        • Recruiting
        • IRCCS Istituto Ortopedico Rizzoli
        • Contact:
          • Davide Reale, MD
      • Lugano, Switzerland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: insertion preserving
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
Anterior cruciate ligament reconstruction with semitendinosus and gracilis tendons completely detached from their insertion at the hamstring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after ACL reconstruction intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3, 12 months after ACL reconstruction intervention
Right anatomical graft position
Time Frame: 12 months after ACL reconstruction intervention
Evaluation of right anatomical graft position by MRI 3 TESLA
12 months after ACL reconstruction intervention
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
3, 6, 12 months after ACL reconstruction intervention
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
3, 6, 12 months after ACL reconstruction intervention
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
3, 6, 12 months after ACL reconstruction intervention
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.
3, 6, 12 months after ACL reconstruction intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Marco Decogliano, MD, EOC - Unità Traumatologia e Ortopedia - ORL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2018

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 30, 2018

First Submitted That Met QC Criteria

November 16, 2018

First Posted (Actual)

November 19, 2018

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ORL-ORT-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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