This is a Study to Evaluate Nanofractures Technique in the Treatment of Cartilage Lesions

Last updated: August 27, 2024
Sponsor: Ente Ospedaliero Cantonale, Bellinzona
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cartilage Injuries

Treatment

Nanofracture

Clinical Study ID

NCT05660161
ORL-ORT-037
  • Ages 16-50
  • All Genders

Study Summary

Articular cartilage lesions, with their inherent limited healing potential, remain a challenging problem for orthopaedic surgeons. Various techniques, both palliative and reparative, have been used to treat this injury with variable success rates. If not adequately treated, they may even lead to the development of early-onset osteoarthritis. Among all the available techniques, microfractures are used in restoring the cartilage tissue, especially in the deep and extended lesions.

More recently, the need for minor bone trauma with still adequate bleeding resulted in the development of nanofractures. Nanofracturing means creating perforations with a smaller diameter that go deeper into the bone while damaging it less. This is supposed to reduce the injury to the subchondral bone and increase the amount of bone marrow-derived mesenchymal stromal cells at the bone surface.

Thus, the aim of this pilot study is to evaluate the efficacy of nanofractures for the treatment of cartilage lesions of the knee, specifically focusing on the chondral healing that will be addressed with magnetic resonance imaging.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with cartilage lesions of the knee scheduled for surgery

  • Age 16-50

  • BMI between 18.5 and 30 points

  • Ability to give informed consent

Exclusion

Exclusion Criteria:

  • Uncorrected knee instability

  • Meniscectomy > 50%

  • Uncorrected knee misalignment

  • Uncontrolled metabolic diseases

  • Inability to give informed consent

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Nanofracture
Phase:
Study Start date:
March 02, 2023
Estimated Completion Date:
January 31, 2026

Connect with a study center

  • EOC

    Lugano, 6900
    Switzerland

    Active - Recruiting

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