RecruitingNot ApplicableNCT04184687

The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction

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

Sponsor

Istituto Ortopedico Rizzoli

Enrollment

88 participants

Start Date

Jul 25, 2019

Study Type

INTERVENTIONAL

Conditions

Cruciate Ligament Rupture Cartilage Injury

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria6

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 Criteria14

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.

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Interventions

PROCEDURENanofractures

anterior cruciate ligament reconstruction will be performed in combination with the nanofractures for the treatment of cartilaginous lesions

PROCEDUREno treatment cartilaginous lesions

patient undergoing to the anterior cruciate ligament reconstruction without treatment of the cartilaginous lesions

Locations(1)

Istituto Ortopedico Rizzoli

Bologna, Italy

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NCT04184687

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