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

Sponsor

Sewon Cellontech Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02519881

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Defect of Articular Cartilage	Procedure: Microfracture Device: CartiFill	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Study Start Date :

Feb 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Change score of 100mmVAS(visual analogue scale) [Screening, 6, 12, and 24months after surgery]
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.
Change of Satisfaction evaluation by patients [Screening, 6, 12, and 24months after surgery]
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.
Change of AOFAS(American orthopaedic foot & ankle society) Score [Screening, 6, 12, and 24months after surgery]
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.
Change of Hannover Score [Screening, 6, 12, and 24months after surgery]
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.
Change of Satisfaction evaluation by physician in charge [Screening, 6, 12, and 24months after surgery]
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.
Change results of Arthroscopy (ICRS(International Cartilage Repair Society)) [before and 24 months after the surgery]
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.
the result of MRI(mMOCART) [24 months after the surgery]
The conditions of the affected ankle 24 months after the surgery were recorded and the mMOCART were evaluated in the study and control group.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients who were 15 years old or older
Patients with cartilage defects in their ankle
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
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:

If patients or their families suffer from or have ever suffered from an autoimmune disease.
Patients who have ever suffered an anaphylactic reaction.
Patients who have ever suffered hypersensitivity to an implant.
Patients with a history of allergy to porcine or bovine protein.
Subjects with inflammatory arthritis, such as rheumatoid and gouty arthritis.
Subjects with autoimmune disease related arthritis.
Subjects who are pregnant and/or breast-feeding and/or plan a pregnancy.
Subjects with tumors.
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).
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.)
Subjects with infections, currently on treatment with antibiotics or antimicrobials (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
Subjects under adrenocorticoid therapy (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
Subjects with psychiatric disorders who are considered inappropriate to participate in this trial by the Principal Investigator.
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.)

Contacts and Locations

Locations

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

Sponsors and Collaborators

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