the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Ankle

This Clinical Trial Evaluated the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Patients With Cartilage Defects in Their Ankles.

This study was designed to evaluate the efficacy and safety of a modified microfracture using collagen, and to compare them with those of a simple microfracture in patients with cartilage defects in their ankles.

Study Overview

• Status: Completed
• Conditions: Defect of Articular Cartilage
• Intervention / Treatment: Procedure: Microfracture; Device: CartiFill

Detailed Description

This study was an open-trial study. Sixty subjects participated in it. The study was explained to the subjects and they voluntarily agreed to participate in it. Their eligibility to participate in the study was checked, and they were randomized either into the simple microfracture group or the modified microfracture group using collagen based on a randomization table. They were asked to follow the guidelines of the investigators during the study and to visit the hospital five times, including for screening. At each visit, the subjects underwent an examination with doctors and MRI to evaluate the efficacy of the procedure. (*If the subject began the first visit on the screening date, the total number of his or her visits was four.)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Gyeonggi-do
    • Bucheon-si, Gyeonggi-do, South Korea
      • Soon Chun Hyang University Hospital Bucheon
  • Seoul
    • Seoul, Seoul, South Korea
      • Eulji General Hospital
    • Seoul, Seoul, South Korea
      • Hallym University Medical Center-Kangnam Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patients who were 15 years old or older
2. Patients with cartilage defects in their ankle
3. Patients with misalignment of their tibia and talus, unstable ligament in their ankle, or bony defects in the lesions of their ankle, and/or who had been treated for alignment
4. Patients or their representative (for adults), or patients and their parent/guardian (for minors), who agreed to participate in the study and signed the informed consent form

Exclusion Criteria:

1. If patients or their families suffer from or have ever suffered from an autoimmune disease.
2. Patients who have ever suffered an anaphylactic reaction.
3. Patients who have ever suffered hypersensitivity to an implant.
4. Patients with a history of allergy to porcine or bovine protein.
5. Subjects with inflammatory arthritis, such as rheumatoid and gouty arthritis.
6. Subjects with autoimmune disease related arthritis.
7. Subjects who are pregnant and/or breast-feeding and/or plan a pregnancy.
8. Subjects with tumors.
9. Subjects who have undergone radiotherapy or chemotherapy within the last 2 years (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
10. Subjects who are diabetic. (Exception: if the possibility of CartiFill™ treatment is confirmed with doctor's clinical decision, and/or patient's blood glucose level remains within the normal range and/or no other complications by diabetes mellitus.)
11. Subjects with infections, currently on treatment with antibiotics or antimicrobials (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
12. Subjects under adrenocorticoid therapy (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
13. Subjects with psychiatric disorders who are considered inappropriate to participate in this trial by the Principal Investigator.
14. Patients who have ever suffered contraindications of the used Fibrin sealant. (The major contraindications are as follows: patients with hypersensitivity to aprotinin and those treatments for severe brisk arterial or venous bleeding.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: modified microfracture using collagen; modified microfracture using collagen (CartiFill) for cartilage defect of ankle	Procedure: Microfracture; simple microfracture of ankle; Device: CartiFill; add collagen when doing microfracture
Active Comparator: microfracture; simple microfracture for cartilage defect of ankle	Procedure: Microfracture; simple microfracture of ankle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
100mmVAS(visual analogue scale) score	The VAS's were evaluated 12 months after the surgery on the affected ankle in the study and control groups.	12 months after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change score of 100mmVAS(visual analogue scale)	The difference in the 100mmVAS on the affected ankle at the screening and after 12 months was compared in the study and control group, as were the differences in the 100mmVAS after 6, and 24 months.	Screening, 6, 12, and 24months after surgery
Change of Satisfaction evaluation by patients	The improvements in the affected ankle before and 12 months after the surgery (and six and 24 months after the surgery) were compared in the study and control group.	Screening, 6, 12, and 24months after surgery
Change of AOFAS(American orthopaedic foot & ankle society) Score	The difference in the AOFAS on the affected ankle at the screening and after 12 months was compared in the study and control group, as were the differences in the AOFAS after 6, and 24 months.	Screening, 6, 12, and 24months after surgery
Change of Hannover Score	The difference in the Hannover Score on the affected ankle at the screening and after 12 months was compared in the study and control group, as were the differences in the Hannover Score after 6, and 24 months.	Screening, 6, 12, and 24months after surgery
Change of Satisfaction evaluation by physician in charge	The improvements in the affected ankle before and 12 months after the surgery (and six and 24 months after the surgery) were compared in the study and control group.	Screening, 6, 12, and 24months after surgery
Change results of Arthroscopy (ICRS(International Cartilage Repair Society))	The conditions of the affected ankle before and 24 months after the surgery were recorded and the ICRS's were evaluated in the study and control group. * Arthroscopy was performed in up to 10 subjects who signed the consent form.	before and 24 months after the surgery
the result of MRI(mMOCART)	The conditions of the affected ankle 24 months after the surgery were recorded and the mMOCART were evaluated in the study and control group.	24 months after the surgery

Collaborators and Investigators

• Sponsor: Sewon Cellontech Co., Ltd.
• Investigators: Principal Investigator: Jin Soo Kim, MD, Eulji General Hospital; Principal Investigator: Young Hwan Kim, MD, Soon Chun Hyang University; Principal Investigator: Hyung Nyun Kim, MD, Hallym University Medical Center-Kangnam Sacred Heart Hospital

Publications and helpful links

General Publications

• Lee YK, Young KW, Kim JS, Lee HS, Cho WJ, Kim HN. Arthroscopic microfracture with atelocollagen augmentation for osteochondral lesion of the talus: a multicenter randomized controlled trial. BMC Musculoskelet Disord. 2020 Nov 3;21(1):716. doi: 10.1186/s12891-020-03730-3.

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2014
• Primary Completion (Actual): January 23, 2018
• Study Completion (Actual): January 23, 2018

Study Registration Dates

• First Submitted: August 6, 2015
• First Submitted That Met QC Criteria: August 10, 2015
• First Posted (Estimated): August 11, 2015

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: collagen; microfracture; cartilage defect in ankle; modified microfracture using collagen
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Stress; Surgical Procedures, Operative; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Arthroplasty, Subchondral
• Other Study ID Numbers: 04CAR