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

Defect of Articular Cartilage Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02519881
• Other study ID #: 04CAR
• Status: Recruiting
• Phase: Phase 4
• First received: August 6, 2015
• Last updated: August 10, 2015
• Start date: February 2014
• Est. completion date: December 2018

Study information

• Verified date: August 2015
• Source: Sewon Cellontech Co., Ltd.
• Contact: Hyun Jo Kim, Bachelor
• Phone: 82-2-460-3237
• Email: angel[@]swcell.com
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug SafetyKorea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cartilage Diseases
• Defect of Articular Cartilage

Intervention

Procedure:
• Microfracture
simple microfracture of ankle

Device:
• CartiFill
add collagen when doing microfracture

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon	Gyeonggi-do
Korea, Republic of	Eulji general Hospital	Seoul
Korea, Republic of	Hallym University Medical Center-Kangnam Sacred Heart Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sewon Cellontech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No