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The surgical procedures described in the study are performed outside the Institute
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nanofractures treatment of the cartilaginous lesions | Experimental | Patients undergoing to anterior cruciate ligament reconstruction with concomitant treatment of the cartilaginous lesions with nanofractures technique. |
|
| no treatment of the cartilaginous lesions | Active Comparator | Patients undergoing to anterior cruciate ligament reconstruction. Cartilaginous lesions won't be treated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanofractures | Procedure | anterior cruciate ligament reconstruction will be performed in combination with the nanofractures for the treatment of cartilaginous lesions |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27043346 | Background | Filardo G, de Caro F, Andriolo L, Kon E, Zaffagnini S, Marcacci M. Do cartilage lesions affect the clinical outcome of anterior cruciate ligament reconstruction? A systematic review. Knee Surg Sports Traumatol Arthrosc. 2017 Oct;25(10):3061-3075. doi: 10.1007/s00167-016-4097-y. Epub 2016 Apr 4. | |
| 20117635 | Background |
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| no treatment cartilaginous lesions | Procedure | patient undergoing to the anterior cruciate ligament reconstruction without treatment of the cartilaginous lesions |
|
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 |
| Brophy RH, Zeltser D, Wright RW, Flanigan D. Anterior cruciate ligament reconstruction and concomitant articular cartilage injury: incidence and treatment. Arthroscopy. 2010 Jan;26(1):112-20. doi: 10.1016/j.arthro.2009.09.002. |