Actively Recruiting
Effectiveness and Safety of Knee Cartilage Lesion Treatment Using CartiONE: 1-to-13 Year Follow-up.
Led by Cartilage Repair Systems BV · Updated on 2025-02-05
100
Participants Needed
5
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness and Safety of Knee Cartilage Lesion Treatment Using CartiONE: 1-to-13 Year Follow-up.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients treated with CartiONE for knee cartilage lesion more than 6 months 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.
You will not qualify if you...
- Patients cannot be included if any condition exists that is judged by the treating surgeon as making the patient not suited for participation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
UZ Ghent
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
2
AZ Monica
Antwerp, Belgium, 2100
Actively Recruiting
3
MIRAI
Warsaw, Poland
Not Yet Recruiting
4
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, United Kingdom
Not Yet Recruiting
5
Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, United Kingdom
Actively Recruiting
Research Team
N
Nele Vanparys
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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