Complete Tear, Knee, Anterior Cruciate Ligament
Conditions
Keywords
arthroscopy
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 .
Interventions
PROCEDUREACL reconstruction preserving insertion
Anterior cruciate ligament reconstruction with semitendinosus and gracilis, preserving their insertion at the level of the hamstring.
PROCEDUREACL reconstruction detaching insertion
Anterior cruciate ligament reconstruction with semitendinosus and gracilis tendons completely detached from their insertion at the hamstring.
Sponsors
Clinical Trial Unit Ente Ospedaliero Cantonale
Ente Ospedaliero Cantonale, Bellinzona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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 |
Countries
Italy, Switzerland
Outcome results
None listed