The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction

Not Applicable

Recruiting

• Conditions: Cartilage Injury; Cruciate Ligament Rupture
• Interventions: Procedure: Nanofractures; Procedure: no treatment cartilaginous lesions

• Registration Number: NCT04184687
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Study Timeline

• Study Start: 2019-07-25
• Study First Submitted: 2019-11-28
• Study First Submitted QC: 2019-11-28
• Study First Posted: 2019-12-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Primary Completion: 2027-07-25
• Study Completion: 2027-07-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nanofractures treatment of the cartilaginous lesions	Nanofractures	Patients undergoing to anterior cruciate ligament reconstruction with concomitant treatment of the cartilaginous lesions with nanofractures technique.
no treatment of the cartilaginous lesions	no treatment cartilaginous lesions	Patients undergoing to anterior cruciate ligament reconstruction. Cartilaginous lesions won't be treated

Primary Outcome Measures

Name	Time	Method
IKDC-subjective score (International Knee Documentation Committee)	24 month	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.
WORMS (Whole-Organ Magnetic Resonance Imaging Score)	24 month	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)

Secondary Outcome Measures

Name	Time	Method
EQ-5D (EuroQoL) Current Health Assessment	6, 12, 24, 36 and 60 months	It is a reliable tools for assessing quality of life of the patient
Tegner Activity Level Scale	6, 12, 24, 36 and 60 months	Survey useful for assessing sport activity of the patient.
KOOS (Knee injury and Osteoarthritis Outcome Score )	6, 12, 24, 36 and 60 months	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
IKDC-subjective score (International Knee Documentation Committee)	6, 12, 36 and 60 months	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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy