The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Cruciate Ligament Rupture; Cartilage Injury

Treatments: Procedure: Nanofractures; Procedure: no treatment cartilaginous lesions

Study type: Interventional

Funder types: Other

Identifiers

NCT04184687

CART-LCA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Nanofractures treatment of the cartilaginous lesions

Experimental group

Description:

Patients undergoing to anterior cruciate ligament reconstruction with concomitant treatment of the cartilaginous lesions with nanofractures technique.

Treatment:

Procedure: Nanofractures

no treatment of the cartilaginous lesions

Active Comparator group

Description:

Patients undergoing to anterior cruciate ligament reconstruction. Cartilaginous lesions won't be treated

Treatment:

Procedure: no treatment cartilaginous lesions