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

NCT ID: NCT05660161

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-02
• Study Completion Date: 2027-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nanofracture

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.

Group Type: EXPERIMENTAL

Nanofracture

Intervention Type: 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.

Interventions

Nanofracture

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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 Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ente Ospedaliero Cantonale, Bellinzona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luca Deabate, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

EOC

Lugano, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Alessandro Sangiorgio, MD

Role: CONTACT

alessandro.sangiorgio@eoc.ch

+41 091 811 7029

Facility Contacts

Christian Candrian, MD

Role: primary

christian.candrian@eoc.ch

+41 (0) 91 811 61 23

Other Identifiers

ORL-ORT-037

Identifier Type: -

Identifier Source: org_study_id