This is a Study to Evaluate Nanofractures Technique in the Treatment of Cartilage Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nanofracture.
- Who it may be relevant to
- Registry conditions: Cartilage Damage. Basic parameters: 16 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Pilot Study to Evaluate the Functional Outcome of Nanofractures for the Treatment of Cartilage Lesions
Overview
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.
Interventions
- Procedure 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 pene
Primary outcome measures
- Functional outcomes measured by International Knee Documentation Committee subjective score [Time frame: 12 months]
Secondary outcome measures (5)
- Functional outcomes measured by International Knee Documentation Committee subjective score [Time frame: 6 months, 24 months]
- Activity level measured by Tegner score [Time frame: 6 months, 12 months, 24 months]
- Knee pain on the Visual Analogic Scale [Time frame: 6 months, 12 months, 24 months]
- Activity level measured by Knee injury and Osteoarthritis Outcome Score [Time frame: 6 months, 12 months, 24 months]
- Cartilage Repair Tissue measured by Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) 2.0 score [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- EOC — Lugano
Identifiers
NCT: NCT05660161 · ORL-ORT-037