Long-term Safety and Efficacy of CartiFill After Microfracture Surgery in Knee Cartilage Defects

NCT07621172 | Completed

• 1 other identifier: 06CAR
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to evaluate the safety and efficacy of CartiFill implanted at the site of knee joint cartilage defect in a 6-year, long-term, follow-up investigation.

Conditions

Cartilage Defects of the Knee

Keywords

Cartilage Defects of the knee joint; microfracture; modified microfracture using collagen; collagen

Outcome Measures

Primary Outcomes (1)

• 100mm VAS (visual analogue scale) score

  100 mm VAS values of the experimental and control groups 6 years (±1 year) after the surgery were analyzed using unpaired T-test or Wilcoxon rank-sum test. The difference between the values from the previously conducted post-marketing clinical trial (Protocol No. 03CAR) and values 6 years (±1 year) after the procedure was also analyzed using unpaired T-test.

  From screening to 6 years (±1 year) after surgery

Secondary Outcomes (8)

• KOOS (Knee injury and Osteoarthritis Outcome Score)

  From screening to 6 years (±1 year) after surgery

• IKDC (International Knee Documentation Committee)

  From screening to 6 years (±1 year) after surgery

• EQ-5D (EuroQol 5 Dimension Scale)

  From screening to 6 years (±1 year) after surgery

• WPAI (Work Productivity and Activity Impairment Questionnaire)

  From screening to 6 years (±1 year) after surgery

• Post-surgical Satisfaction (Subject)

  6 years (±1 year) after surgery

Study Arms (1)

Experimental: modified microfracture using collagen (CartiFill)

Subjects with knee cartilage defects who previously underwent microfracture surgery with CartiFill (atelocollagen) implantation in a prior clinical study (Protocol No. 03CAR) and were enrolled for long-term follow-up. Participants were observed for up to 6 years to evaluate the long-term safety and efficacy outcomes without additional intervention.

Device: CartiFill; Procedure: Microfracture

Interventions

CartiFill DEVICE

add collagen when doing microfracture

Experimental: modified microfracture using collagen (CartiFill)

Microfracture PROCEDURE

simple microfracture of ankle

Experimental: modified microfracture using collagen (CartiFill)

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of subjects with cartilage defects of the knee joint who had previously participated in a post-marketing clinical trial (Protocol No. 03CAR) and had undergone microfracture surgery with or without collagen implantation. Subjects were enrolled approximately 6 years (±1 year) after surgery and voluntarily agreed to participate in this long-term follow-up study.

You may qualify if:

• Patients who have undergone microfracture surgery or microfracture surgery using collagen 6 years (±1 year) ago as part of the previously conducted post-marketing clinical trial (Protocol No. 03CAR).
• Males or females aged 19 to 70 years.
• Patients or patients whose legal representatives have agreed to participate in the clinical trial and signed the written consent.

You may not qualify if:

• Patients who have undergone microfracture surgery or microfracture surgery using collagen as part of previously conducted post-marketing clinical trial (Protocol No. 03CAR) but have since then received cartilage surgery, such as high tibial osteotomy (HTO), partial/full implant arthroplasty, etc., at the same site. (Does not include biopsy for diagnosis, a simple arthroscopic examination, or HTO plate removal procedure, etc.)
• ※ Does not include non-invasive treatment or medication such as exercise therapy, physical therapy, manual therapy, extracorporeal shock wave, joint cavity injection, etc.
• Patients who are deemed by the clinical trial manager to be unfit to participate due to psychiatric conditions, etc.

Sponsors & Collaborators

• Cellontech Co., Ltd.: lead

Study Sites (1)

Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Fractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Yong In, MD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

• JongSeok Baek, MD

  Wonkwang University Hospital

  PRINCIPAL INVESTIGATOR

• SeungBaek Kang

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

• JunHo Hwang

  Samsung Seoul Hospital

  PRINCIPAL INVESTIGATOR

• JaYoung Choi, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: June 2, 2026
• Study Start: February 3, 2020
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2021
• Last Updated: June 2, 2026

Record last verified: 2026-04

Locations

KR (1)