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TerminatedNCT04184687Updated May 22, 2026

The Treatment of Cartilaginous Lesions and Concomitant Anterior Cruciate Ligament Reconstruction

An interventional study of Nanofractures and no treatment cartilaginous lesions in Cruciate Ligament Rupture and Cartilage Injury, sponsored by Istituto Ortopedico Rizzoli. Terminated at 1 site in Italy. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment

Why this study was terminated
The surgical procedures described in the study are performed outside the Institute

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jul 2019, registered Nov 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cruciate Ligament Rupture
  • Cartilage Injury
03

In context

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureNanofractures

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

  • Procedureno treatment cartilaginous lesions

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 month

  2. 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)

    Time frame: 24 month

Secondary outcomes

  1. 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.

    Time frame: 6, 12, 36 and 60 months

  2. Tegner Activity Level Scale

    Survey useful for assessing sport activity of the patient.

    Time frame: 6, 12, 24, 36 and 60 months

  3. 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

    Time frame: 6, 12, 24, 36 and 60 months

  4. EQ-5D (EuroQoL) Current Health Assessment

    It is a reliable tools for assessing quality of life of the patient

    Time frame: 6, 12, 24, 36 and 60 months

07

Study locations

1 site
  • Istituto Ortopedico Rizzoli
    Bologna, Italy
08

References and documents

Publications

  • 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. PubMed 27043346 ↗
  • 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. PubMed 20117635 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04184687
Lead sponsor
Istituto Ortopedico Rizzoli
Responsible party
Sponsor
First posted
Dec 3, 2019
Start date
Jul 25, 2019
Primary completion
Oct 10, 2023
Completion
Oct 10, 2023
Last update
May 22, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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