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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2024
Source Istituto Ortopedico Rizzoli
Contact Alessandro Di Martino
Phone 0516366567
Email alessandro.dimartino@ior.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Nanofractures
anterior cruciate ligament reconstruction will be performed in combination with the nanofractures for the treatment of cartilaginous lesions
no treatment cartilaginous lesions
patient undergoing to the anterior cruciate ligament reconstruction without treatment of the cartilaginous lesions

Locations

Country Name City State
Italy Istituto Ortopedico Rizzoli Bologna

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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

Outcome

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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