Cartilage Injury Clinical Trial
Official title:
Randomized Study on the Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction
NCT number | NCT04184687 |
Other study ID # | CART-LCA |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 25, 2019 |
Est. completion date | July 25, 2027 |
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.
Status | Recruiting |
Enrollment | 88 |
Est. completion date | July 25, 2027 |
Est. primary completion date | July 25, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: 1. Male or female patients, 18 < age < 55; 2. Patients with complete ACL injury candidates for surgical reconstruction of the same; 3. Cartilaginous lesion of the femur-tibial compartment of grade III-IV ICRS =3 cm2 confirmed intra-operatively; 4. Patients without evidence of osteoarthritis 5. Patients' ability and consent to participate in clinical and radiological follow-up; 6. Signature of informed consent. Exclusion Criteria: 1. Patients incapable of understanding and of wanting; 2. State of immunodepression; 3. Patients with malignant neoplasms; 4. Patients suffering from rheumatic diseases; 5. Patients suffering from non-compensated diabetes; 6. Patients suffering from uncompensated thyroid metabolic disorders; 7. Patients abusing alcoholic beverages, drugs or drugs; 8. Patients with axial deviations> 5 °; 9. Body Mass Index> 35; 10. Patients treated with surgery at the same knee in the previous 12 months. 11. Cartilaginous lesions grade I-II according to the ICRS score. 12. Cartilage lesions with a diameter greater than 3 cm². 13. Non-suturable meniscal lesions requiring meniscectomy> 50% and patients with previous meniscectomies> 50% in the same compartment. 14. Need for further associated surgical procedures in addition to the reconstruction of ACL and possibly the nanofractures. |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Ortopedico Rizzoli | Bologna |
Lead Sponsor | Collaborator |
---|---|
Istituto Ortopedico Rizzoli |
Italy,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Tegner Activity Level Scale | Survey useful for assessing sport activity of the patient. | 6, 12, 24, 36 and 60 months | |
Secondary | 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 | |
Secondary | 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 |
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