Clinical trial NCT04184687: The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction
Official title: Randomized Study on the Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cruciate Ligament Rupture
Cartilage Injury
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: IKDC-subjective score (International Knee Documentation Committee)
timeFrame: 24 month
measure: WORMS (Whole-Organ Magnetic Resonance Imaging Score)
timeFrame: 24 month
Secondary outcomes:
measure: IKDC-subjective score (International Knee Documentation Committee)
timeFrame: 6, 12, 36 and 60 months
measure: Tegner Activity Level Scale
timeFrame: 6, 12, 24, 36 and 60 months
measure: KOOS (Knee injury and Osteoarthritis Outcome Score )
timeFrame: 6, 12, 24, 36 and 60 months
measure: EQ-5D (EuroQoL) Current Health Assessment
timeFrame: 6, 12, 24, 36 and 60 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
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.
citation: 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.