Evaluating the effectiveness and safety of CartiONE for knee cartilage lesions over time
Official title: Effectiveness and Safety of Knee Cartilage Lesion Treatment Using CartiONE: 1-to-13 Year Follow-up
Run by Cartilage Repair Systems BV · NCT06809231 · Data updated 2026-11-12
This study is testing if the CartiONE treatment can safely help people with knee cartilage damage feel better over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Cartilage Repair Systems BV Industry-sponsored |
| Locations | 5 sites (Ghent, Oost-Vlaanderen and 4 other locations) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | February 5, 2025 |
| Trial ID | NCT06809231 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients who have undergone CartiONE treatment for knee cartilage lesions at least six months prior to the study.
✕Probably not a fit
Patients with conditions that make them unsuitable for participation as judged by their treating surgeon will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study assesses the effectiveness and safety of the CartiONE technique, which is used for treating symptomatic focal articular cartilage lesions in the knee. It involves collecting retrospective baseline and follow-up data from patients treated with CartiONE between 2010 and 2023, with a minimum follow-up period of six months. The study will analyze patient records, including medical history and treatment outcomes, to evaluate the clinical effectiveness and safety of the treatment. The primary endpoints focus on safety through adverse events and effectiveness through cartilage defect volume fill.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of CartiONE treatment for knee cartilage lesions.
How similar studies have gone: Previous studies using similar cartilage repair techniques have shown promising results, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients treated with CartiONE for knee cartilage lesion more than 6months prior to inclusion in this study. * The study site holds a patient record of all relevant medical history data, including operation reports of any prior knee surgeries, the index-knee surgery report, and posttreatment observations and re-intervention reports, if applicable. Exclusion Criteria: * Patients cannot be included if any condition exists that is judged by the treating surgeon as making the patient not suited for participation.
Where it's running
-
UZ Ghent
Ghent, Oost-Vlaanderen, Belgium Recruiting -
AZ Monica
Antwerp, Belgium Recruiting -
Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, United Kingdom Recruiting -
Mirai
Warsaw, Poland Not yet recruiting -
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, United Kingdom Not yet recruiting
Study contacts
- Study coordinator: Nele Vanparys
- Email: nvanparys@orteq.com
- Phone: +34665245704
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.