Clinical trial NCT03746470: A Study to Compare Two Techniques for the Reconstruction of the Anterior Cruciate Ligament
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complete Tear, Knee, Anterior Cruciate Ligament
Keywords: arthroscopy
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
Collaborators: name: Clinical Trial Unit Ente Ospedaliero Cantonale
First posted: 2018-11-19
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


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

Primary outcomes:
measure: Graft integration by the Signal / Noise Quotient (SNQ) at 6 months
timeFrame: 6 months after ACL reconstruction intervention
Secondary outcomes:
measure: Graft integration by the Signal / Noise Quotient (SNQ) at 3 and 12 months
timeFrame: 3, 12 months after ACL reconstruction intervention
measure: Right anatomical graft position
timeFrame: 12 months after ACL reconstruction intervention
measure: Anterior tibial translation
timeFrame: 3, 6, 12 months after ACL reconstruction intervention
measure: Anterior knee joint instability
timeFrame: 3, 6, 12 months after ACL reconstruction intervention
measure: IKDC (International Knee Documentation Committee) questionnaire
timeFrame: 3, 6, 12 months after ACL reconstruction intervention
measure: Tegner activity scale
timeFrame: 3, 6, 12 months after ACL reconstruction intervention
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
city: Lugano
country: Switzerland
facility: EOC - Unità Traumatologia e Ortopedia ORL
Study officials:
affiliation: EOC - Unità Traumatologia e Ortopedia - ORL
name: Marco Decogliano, MD
role: STUDY_CHAIR
References: