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

Ente Ospedaliero Cantonale, Bellinzona

Status: Completed

Conditions: Complete Tear, Knee, Anterior Cruciate Ligament

Treatments: Procedure: ACL reconstruction preserving insertion; Procedure: ACL reconstruction detaching insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT03746470

ORL-ORT-003

Details and patient eligibility

About

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 .

Enrollment: 85 patients

Sex: All

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

insertion preserving

Experimental group

Description:

ACL reconstruction preserving insertion

Treatment:

Procedure: ACL reconstruction preserving insertion

insertion detaching

Active Comparator group

Description:

ACL reconstruction detaching insertion

Treatment:

Procedure: ACL reconstruction detaching insertion