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

Not Applicable

Recruiting

• Conditions: Complete Tear, Knee, Anterior Cruciate Ligament
• Interventions: Procedure: ACL reconstruction preserving insertion; Procedure: ACL reconstruction detaching insertion

• Registration Number: NCT03746470
• Lead Sponsor: Ente Ospedaliero Cantonale, Bellinzona

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-22
• Study First Submitted: 2018-10-30
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-16
• Last Update Posted: 2024-07-17
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
insertion preserving	ACL reconstruction preserving insertion	ACL reconstruction preserving insertion
insertion detaching	ACL reconstruction detaching insertion	ACL reconstruction detaching insertion

Primary Outcome Measures

Name	Time	Method
Graft integration by the Signal / Noise Quotient (SNQ) at 6 months	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

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

Trial Locations

Locations (2)

IRCCS Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy

EOC - Unità Traumatologia e Ortopedia ORL; 🇨🇭 Lugano, Switzerland