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RECRUITING
NCT06809231

Effectiveness and Safety of Knee Cartilage Lesion Treatment Using CartiONE: 1-to-13 Year Follow-up.

Sponsor: Cartilage Repair Systems BV

View on ClinicalTrials.gov

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

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