RecruitingNCT06809231

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

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


Sponsor

Cartilage Repair Systems BV

Enrollment

100 participants

Start Date

Mar 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria1

  • Patients cannot be included if any condition exists that is judged by the treating surgeon as making the patient not suited for participation.

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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

View Full Details on ClinicalTrials.gov

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NCT06809231