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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Cartilage Lesion

Detailed Description

Inclusion and exclusion criteria Inclusion criteria 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.

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

Statistics This is a retrospective, open label, non-randomized, single arm trial. Since different questionnaires for effectiveness and for quality of life (e.g., KOOS, EQ-5D,…) may have been used, the total score of the questionnaires ranging from the minimum total score (i.e. 0 or 1) to the maximum total score will be transformed into the range from 0 respective 1 to 100. Now they can be combined across patients and effectiveness questionnaires or across patients and quality of life questionnaires. Details will be provided in the Statistical Analysis Plan.

There are two co-primary endpoints:

Primary endpoint safety:

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

Primary endpoint effectiveness:

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

Efficacy/Effectiveness:

Key secondary endpoints:

Non-inferiority in MOCART/MOCART 2.0 total scores when measured at two different visits, i.e., at the reference visit and later.

Non-inferiority in mean "Radiologist's overall knee status assessment" when measured on a scale from 0 (extremely bad) to 100 (extremely good) at two different visits, i.e., at the reference visit and later.

Other secondary endpoints:

Improvement in other effectiveness questionnaire total scores Improvement in quality-of-life total scores Improvement in other questionnaires when applicable

Exploratory endpoint:

"Radiologist's overall knee status assessment" on a scale from 0 (extremely bad) to 100 (extremely good) of the two readers.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Nele Vanparys; Phone Number: +34665245704; Email: nvanparys@orteq.com

Study Locations

• Belgium
  • Antwerp, Belgium, 2100
    • Recruiting
    • AZ Monica
    • Principal Investigator: Peter Verdonk
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • Recruiting
      • UZ Ghent
      • Principal Investigator: Jan Victor
• Poland
  • Warsaw, Poland
    • Not yet recruiting
    • MIRAI
    • Principal Investigator: Konrad Slynarski
• United Kingdom
  • Coventry, United Kingdom
    • Not yet recruiting
    • University Hospitals Coventry & Warwickshire NHS Trust
    • Principal Investigator: Andy Metcalfe
  • Oswestry, United Kingdom
    • Recruiting
    • Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
    • Principal Investigator: Paul Jermin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with CartiONE for knee cartilage lesions

Description

Inclusion Criteria:

• 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 Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients treated with CartiONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Cartilage Repair Systems BV

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: ICONIC; intraoperative; knee cartilage; chondron; CartiONE; coimplantation; one stage
• Other Study ID Numbers: CRS001-2023; IRAS ID 345492 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No