The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction

May 20, 2026 updated by: Istituto Ortopedico Rizzoli

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy
        • Istituto Ortopedico Rizzoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nanofractures treatment of the cartilaginous lesions
Patients undergoing to anterior cruciate ligament reconstruction with concomitant treatment of the cartilaginous lesions with nanofractures technique.
Procedure: Nanofractures
anterior cruciate ligament reconstruction will be performed in combination with the nanofractures for the treatment of cartilaginous lesions
Active Comparator: no treatment of the cartilaginous lesions
Patients undergoing to anterior cruciate ligament reconstruction. Cartilaginous lesions won't be treated
Procedure: no treatment cartilaginous lesions
patient undergoing to the anterior cruciate ligament reconstruction without treatment of the cartilaginous lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IKDC-subjective score (International Knee Documentation Committee)
Time Frame: 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.
24 month
WORMS (Whole-Organ Magnetic Resonance Imaging Score)
Time Frame: 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)
24 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2019

Primary Completion (Actual)

October 10, 2023

Study Completion (Actual)

October 10, 2023

Study Registration Dates

First Submitted

November 28, 2019

First Submitted That Met QC Criteria

November 28, 2019

First Posted (Actual)

December 3, 2019

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CART-LCA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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