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

NCT05660161 | Recruiting

• 1 other identifier: ORL-ORT-037
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cartilage Damage

Outcome Measures

Primary Outcomes (1)

• Functional outcomes measured by International Knee Documentation Committee subjective score

  The IKDC subjective score is a patient-completed tool to evaluate knee function. It contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  12 months

Secondary Outcomes (5)

• Functional outcomes measured by International Knee Documentation Committee subjective score

  6 months, 24 months

• Activity level measured by Tegner score

  6 months, 12 months, 24 months

• Knee pain on the Visual Analogic Scale

  6 months, 12 months, 24 months

• Activity level measured by Knee injury and Osteoarthritis Outcome Score

  6 months, 12 months, 24 months

• Cartilage Repair Tissue measured by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) 2.0 score

  12 months

Study Arms (1)

Nanofracture

EXPERIMENTAL

The planned study intervention consists of nanofracture surgical procedure for the treatment of cartilage lesions of the knee. Nanofractures will be standardized 9 mm deep perforations in the subchondral bone. Under arthroscopic view, the cartilage lesion is shaved to expose the margins of the lesion and remove damaged tissue. After a satisfactory lesion debridement is performed, a nanofracture device (Plasmaconcept NanoFx®) is placed through the arthroscopic portal. The awl is repeatedly penetrated through the bone until marrow elements are seen in the joint. The flow of arthroscopic fluid is interrupted to better observe the marrow elements emanating from the nanofracture holes. The distance between two consecutive perforations will be approximately 2-3 mm, and the number of perforations will depend on the cartilage lesion extension. All post-operative procedures, including the rehabilitation protocol, will be carried out according to the usual standard of care.

Procedure: Nanofracture

Interventions

Nanofracture PROCEDURE

The planned study intervention consists of nanofracture surgical procedure for the treatment of cartilage lesions of the knee. Nanofractures will be standardized 9 mm deep perforations in the subchondral bone. Under arthroscopic view, the cartilage lesion is shaved to expose the margins of the lesion and remove damaged tissue. After a satisfactory lesion debridement is performed, a nanofracture device (Plasmaconcept NanoFx®) is placed through the arthroscopic portal. The awl is repeatedly penetrated through the bone until marrow elements are seen in the joint. The flow of arthroscopic fluid is interrupted to better observe the marrow elements emanating from the nanofracture holes. The distance between two consecutive perforations will be approximately 2-3 mm, and the number of perforations will depend on the cartilage lesion extension. All post-operative procedures, including the rehabilitation protocol, will be carried out according to the usual standard of care.

Nanofracture

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Uncorrected knee instability
• Meniscectomy \> 50%
• Uncorrected knee misalignment
• Uncontrolled metabolic diseases
• Inability to give informed consent

Sponsors & Collaborators

• Ente Ospedaliero Cantonale, Bellinzona: lead

Study Sites (1)

EOC

Lugano, 6900, Switzerland

RECRUITING

Study Officials

• Luca Deabate, MD

  Service of Orthopaedics and Traumatology, Department of Surgery, EOC, Lugano, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Sangiorgio, MD

CONTACT

+41 091 811 7029; alessandro.sangiorgio@eoc.ch

Study Design

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

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: December 21, 2022
• Study Start: March 2, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)