The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction

Cartilage Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04184687
• Other study ID #: CART-LCA
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2019
• Est. completion date: July 25, 2027

Study information

• Verified date: May 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: Alessandro Di Martino
• Phone: 0516366567
• Email: alessandro.dimartino[@]ior.it
• Is FDA regulated: No
• 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.

Related Conditions & MeSH terms

• Cartilage Injury
• Cruciate Ligament Rupture
• Rupture

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