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

NCT06809231 | Recruiting

• 2 other identifiers: CRS001-2023IRAS ID 345492
• Study Type: observational
• Target: 100
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

Knee Cartilage Lesion

Keywords

knee cartilage; CartiONE; ICONIC; coimplantation; chondron; one stage; intraoperative

Outcome Measures

Primary Outcomes (2)

• Adverse events with particular focus on Treatment failure rate and on other AESIs

  periprocedurally, through to study completion up to 2 years

• MOCART sub-score 1 "Volume fill of cartilage defect"

  baseline, month 3, month 6, year 1, year 2

Study Arms (1)

Patients treated with CartiONE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with CartiONE for knee cartilage lesions

You may qualify if:

• 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.

Sponsors & Collaborators

• Cartilage Repair Systems BV: lead

Study Sites (5)

UZ Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

AZ Monica

Antwerp, 2100, Belgium

RECRUITING

MIRAI

Warsaw, Poland

NOT YET RECRUITING

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, United Kingdom

NOT YET RECRUITING

Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, United Kingdom

RECRUITING

Related Links

• Related Info

Central Study Contacts

Nele Vanparys

CONTACT

+34665245704; nvanparys@orteq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: February 5, 2025
• Study Start: March 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); GB (2); BE (2)