The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction

NCT04184687 | Recruiting

• 1 other identifier: CART-LCA
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Cruciate Ligament Rupture; Cartilage Injury

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• IKDC-subjective score (International Knee Documentation Committee)

  6, 12, 36 and 60 months

• Tegner Activity Level Scale

  6, 12, 24, 36 and 60 months

• KOOS (Knee injury and Osteoarthritis Outcome Score )

  6, 12, 24, 36 and 60 months

• EQ-5D (EuroQoL) Current Health Assessment

  6, 12, 24, 36 and 60 months

Study Arms (2)

Nanofractures treatment of the cartilaginous lesions

EXPERIMENTAL

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

Procedure: Nanofractures

no treatment of the cartilaginous lesions

ACTIVE COMPARATOR

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

Procedure: no treatment cartilaginous lesions

Interventions

Nanofractures PROCEDURE

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

Nanofractures treatment of the cartilaginous lesions

no treatment cartilaginous lesions PROCEDURE

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

no treatment of the cartilaginous lesions

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Italy

RECRUITING

Related Publications (2)

• 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.

  PMID: 27043346 BACKGROUND

• 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.

  PMID: 20117635 BACKGROUND

Central Study Contacts

Alessandro Di Martino

CONTACT

0516366567; alessandro.dimartino@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 3, 2019
• Study Start: July 25, 2019
• Primary Completion (Estimated): July 25, 2027
• Study Completion (Estimated): July 25, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

IT (1)