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

NCT03746470 | Completed

• 1 other identifier: ORL-ORT-003
• Study Type: interventional
• Target: 85
• Locations: 2 countries
• Sites: 2

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 .

Conditions

Complete Tear, Knee, Anterior Cruciate Ligament

Keywords

arthroscopy

Outcome Measures

Primary Outcomes (1)

• 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

  6 months after ACL reconstruction intervention

Secondary Outcomes (6)

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

  3, 12 months after ACL reconstruction intervention

• Right anatomical graft position

  12 months after ACL reconstruction intervention

• Anterior tibial translation

  3, 6, 12 months after ACL reconstruction intervention

• Anterior knee joint instability

  3, 6, 12 months after ACL reconstruction intervention

• IKDC (International Knee Documentation Committee) questionnaire

  3, 6, 12 months after ACL reconstruction intervention

Study Arms (2)

insertion preserving

EXPERIMENTAL

ACL reconstruction preserving insertion

Procedure: ACL reconstruction preserving insertion

insertion detaching

ACTIVE COMPARATOR

ACL reconstruction detaching insertion

Procedure: ACL reconstruction detaching insertion

Interventions

ACL reconstruction preserving insertion PROCEDURE

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

insertion preserving

ACL reconstruction detaching insertion PROCEDURE

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

insertion detaching

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead
• Clinical Trial Unit Ente Ospedaliero Cantonale: collaborator

Study Sites (2)

IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy

Location

EOC - Unità Traumatologia e Ortopedia ORL

Lugano, Switzerland

Location

Study Officials

• Marco Decogliano, MD

  EOC - Unità Traumatologia e Ortopedia - ORL

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 19, 2018
• Study Start: October 22, 2018
• Primary Completion: September 29, 2024
• Study Completion: September 29, 2024
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

IT (1); CH (1)