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

Complete Tear, Knee, Anterior Cruciate Ligament Clinical Trial

— ACL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03746470
• Other study ID #: ORL-ORT-003
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: Marco Decogliano, MD
• Phone: +41918117029
• Email: RicercaOrtopedia.ORL[@]eoc.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Complete Tear, Knee, Anterior Cruciate Ligament

Intervention

Procedure:
• ACL reconstruction preserving insertion
Anterior cruciate ligament reconstruction with semitendinosus and gracilis, preserving their insertion at the level of the hamstring.
• ACL reconstruction detaching insertion
Anterior cruciate ligament reconstruction with semitendinosus and gracilis tendons completely detached from their insertion at the hamstring.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Rizzoli	Bologna
Switzerland	EOC - Unità Traumatologia e Ortopedia ORL	Lugano

Sponsors (2)

Lead Sponsor	Collaborator
Ente Ospedaliero Cantonale, Bellinzona	Clinical Trial Unit Ente Ospedaliero Cantonale

Countries where clinical trial is conducted

Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Graft integration by the Signal / Noise Quotient (SNQ) at 3 and 12 months	Signal intensity of the graft evaluated by the Signal / Noise Quotient (SNQ) during MRI 3 Tesla	3, 12 months after ACL reconstruction intervention
Secondary	Right anatomical graft position	Evaluation of right anatomical graft position by MRI 3 TESLA	12 months after ACL reconstruction intervention
Secondary	Anterior tibial translation	Anterior tibial translation will be measured in millimeters using the arthrometer Rolimeter	3, 6, 12 months after ACL reconstruction intervention
Secondary	Anterior knee joint instability	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
Secondary	IKDC (International Knee Documentation Committee) questionnaire	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
Secondary	Tegner activity scale	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