Nanochon Chondrograft First in Human (FIH) Early Feasibility Study (EFS) - Canada
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: Nanochon Chondrograft.
- Who it may be relevant to
- Registry conditions: Knee Cartilage Lesions. Basic parameters: 22 years — 60 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
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A First in Human (FIH) Early Feasibility Study (EFS) to Evaluate the Safety and Performance of the Nanochon Chondrograft™ Implant for Re-surfacing of Cartilage Lesions
Overview
The goal of this First in Human study is to learn if the Nanochon Chondrograft Implant is a safe primary surgical treatment for participants with cartilage lesions in the knee. This study will include males and females between the ages of 22 and 60.
Interventions
- Device Nanochon Chondrograft
Mini arthrotomy or arthroscopic surgical implantation of the Nanochon Chondrograft
Primary outcome measures
- Serious Adverse Device Event Effects [Time frame: Month 12]
Eligibility criteria
Inclusion criteria
- Male or female ≥22 years and ≤ 60 years of age
- MRI knee evaluation completed within 6 months prior to enrollment
- Participant must be able to read and speak English
- Participant must voluntarily sign the REB approved informed consent form (ICF)
Exclusion criteria
- Any known systemic cartilage and/or bone disorder, such as, but not limited to, osteoporosis, chondrodysplasia or osteogenesis imperfecta
- Requires bilateral knee surgery
- Pregnancy, planning to become pregnant or breast feeding
- Any significant illness (metastasis cancer of any type) that decreases the probability of the participant's survival to 12 months
- Known insulin dependent diabetes mellitus
- Steroid treatment (oral or IV) within the past 6 months
- Participant is:
- receiving workman's compensation
- receiving prescription narcotic medication
- active with litigation relating to musculoskeletal injuries or disorders
- a prisoner or pending incarceration
- Comorbidities that could impact study participation or results (e.g., autoimmune disorder, HIV, neuropathic pain or fibromyalgia, restless leg syndrome, active infection, or pain requiring chronic pain management), in the opinion of the investigator at the time of enrollment
- Significant psychiatric disorders (e.g., major depression, anxiety disorders, bipolar disorder, and schizophrenia)
- Substance and/or alcohol dependence and/or abuse based on clinical history, physical exam and participant presentation
- Current participation in another drug or device study that, in the opinion of the investigator at the time of enrollment, would interfere with participation in this study
- Participant has claustrophobia or implanted metallic devices (e.g., cardiac pacemakers, insulin pumps, nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI
- Known allergy or hypersensitivity to any investigational device materials.
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
Canada · 2 centers
- University of British Columbia — Vancouver
- Orthopaedic Clinic — Toronto
Identifiers
NCT: NCT07249489 · 101-2024-CAN