A Pilot Study to Evaluate the Functional Outcome of Nanofractures for the Treatment of Cartilage Lesions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cartilage Damage
- Sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Functional outcomes measured by International Knee Documentation Committee subjective score
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Functional outcomes measured by International Knee Documentation Committee subjective score
Time Frame: 12 months
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).
Secondary Outcomes
- 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)