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

Recruiting now

Conditions studied: Knee Cartilage Lesion

In brief

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.

Key facts

Study ID

NCT06809231

Run by

Cartilage Repair Systems BV

People needed

100

Starts

2024-03-01

Expected to finish

2025-12-01

Last updated by the study team

2025-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• UZ Ghent — Ghent, Oost-Vlaanderen, Belgium (enrolling)
• AZ Monica — Antwerp, Belgium (enrolling)
• Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust — Oswestry, United Kingdom (enrolling)
• MIRAI — Warsaw, Poland
• University Hospitals Coventry & Warwickshire NHS Trust — Coventry, United Kingdom

Full record on ClinicalTrials.gov

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