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

Ente Ospedaliero Cantonale, Bellinzona2 sites in 2 countries85 target enrollmentOctober 22, 2018

ConditionsComplete Tear, Knee, Anterior Cruciate Ligament

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Complete Tear, Knee, Anterior Cruciate Ligament
Sponsor: Ente Ospedaliero Cantonale, Bellinzona
Enrollment: 85
Locations: 2
Primary Endpoint: Graft integration by the Signal / Noise Quotient (SNQ) at 6 months
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 .

Registry

clinicaltrials.gov

Start Date

October 22, 2018

End Date

September 29, 2024

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ente Ospedaliero Cantonale, Bellinzona

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)
Tegner activity scale(3, 6, 12 months after ACL reconstruction intervention)