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Effectiveness and Safety of Knee Cartilage Lesion Treatment Using CartiONE: 1-to-13 Year Follow-up.
Sponsor: Cartilage Repair Systems BV
Summary
CartiONE is a technique used in autologous articular-chondrocyte-based treatments for symptomatic focal articular-cartilage lesions of the knee. The CartiONE technique was evaluated in combination with an osteochondrally placed, biodegradable, biocompatible, load-bearing copolymer (PolyActive) scaffold in the INSTRUCT trial (NCT01041885). To evaluate the clinical effectiveness of the CartiONE technique and confirm its safety, in this study retrospective baseline data and follow-up data, documented as per the standard of care at the participating hospitals, will be collected for patients who were treated with CartiONE. The potential number of patients in this study is 122 and involves patients treated with CartiONE from 2010 to 2023 with a minimum follow-up period of six months, spread across five countries: Belgium, England, Greece, Poland, and Austria.
Official title: Effectiveness and Safety of Knee Cartilage Lesion Treatment Using CartiONE: 1-to-13 Year Follow-up
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2024-03-01
Completion Date
2025-12
Last Updated
2025-02-05
Healthy Volunteers
No
Conditions
Locations (5)
UZ Ghent
Ghent, Oost-Vlaanderen, Belgium
AZ Monica
Antwerp, Belgium
MIRAI
Warsaw, Poland
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, United Kingdom
Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, United Kingdom