The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction

Study Overview
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Brief Summary
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The aim of the study is the evaluation of both clinical and radiological results in patients undergone to cruciate ligament reconstruction with concomitant cartilaginous lesion treated with or without nanofractures.

Detailed Description
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The anterior cruciate ligament lesion is one of the most common disease conditions in the orthopedic clinical practice. The mechanism of injury is due to a direct or indirect knee trauma causing both ligamentous breaking and surface articular stress, with cartilaginous lesion often associated to the lesion of the anterior cruciate ligament. The treatment of these lesions in combination with the treatment of the anterior cruciate ligament is controversial, more controversial is to understand the indication to treatment for these lesions. In order to clarify this aspect and provide a more reliable therapeutic indication for the treatment of the cartilaginous lesion with concomitant anterior cruciate ligament lesion we want to compare the clinical outcomes of the non-treated cartilaginous lesions against the treated cartilaginous lesions wiht nonofractures.

Official Title
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Randomized Study on the Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction

Conditions
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Cruciate Ligament Rupture, Cartilage Injury

Intervention / Treatment
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* Procedure: Nanofractures
* Procedure: no treatment cartilaginous lesions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients, 18 < age < 55; Patients with complete ACL injury candidates for surgical reconstruction of the same; Cartilaginous lesion of the femur-tibial compartment of grade III-IV ICRS ≤3 cm2 confirmed intra-operatively; Patients without evidence of osteoarthritis Patients' ability and consent to participate in clinical and radiological follow-up; Signature of informed consent. Exclusion Criteria: Patients incapable of understanding and of wanting; State of immunodepression; Patients with malignant neoplasms; Patients suffering from rheumatic diseases; Patients suffering from non-compensated diabetes; Patients suffering from uncompensated thyroid metabolic disorders; Patients abusing alcoholic beverages, drugs or drugs; Patients with axial deviations> 5 °; Body Mass Index> 35; Patients treated with surgery at the same knee in the previous 12 months. Cartilaginous lesions grade I-II according to the ICRS score. Cartilage lesions with a diameter greater than 3 cm². Non-suturable meniscal lesions requiring meniscectomy> 50% and patients with previous meniscectomies> 50% in the same compartment. Need for further associated surgical procedures in addition to the reconstruction of ACL and possibly the nanofractures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nanofractures treatment of the cartilaginous lesions<br>Patients undergoing to anterior cruciate ligament reconstruction with concomitant treatment of the cartilaginous lesions with nanofractures technique. | Procedure: Nanofractures<br>* anterior cruciate ligament reconstruction will be performed in combination with the nanofractures for the treatment of cartilaginous lesions<br>|
| Active Comparator: no treatment of the cartilaginous lesions<br>Patients undergoing to anterior cruciate ligament reconstruction. Cartilaginous lesions won't be treated | Procedure: no treatment cartilaginous lesions<br>* patient undergoing to the anterior cruciate ligament reconstruction without treatment of the cartilaginous lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKDC-subjective score (International Knee Documentation Committee) | It is a specific subjective rating scale for te knee. Iti s one of the most reliable tools for assessing knee diseases. The survey examines three categories: symptoms, sport activity, knee function. | 24 month | 
| WORMS (Whole-Organ Magnetic Resonance Imaging Score) | Magnetic resonance imaging will be evaluated through WORMS. The score evaluated five aspects of the three knee compartments (cartilage, bone marrow abnormalities, bone cysts, bone attrition and osteophytes) as well as the soft tissue (menisci, ligaments and synovium) | 24 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKDC-subjective score (International Knee Documentation Committee) | It is a specific subjective rating scale for te knee. Iti s one of the most reliable tools for assessing knee diseases. The survey examines three categories: symptoms, sport activity, knee function. | 6, 12, 36 and 60 months | 
| Tegner Activity Level Scale | Survey useful for assessing sport activity of the patient. | 6, 12, 24, 36 and 60 months | 
| KOOS (Knee injury and Osteoarthritis Outcome Score ) | KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale | 6, 12, 24, 36 and 60 months | 
| EQ-5D (EuroQoL) Current Health Assessment | It is a reliable tools for assessing quality of life of the patient | 6, 12, 24, 36 and 60 months |