Back to resultsthe Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Ankle
Primary Purpose
Defect of Articular Cartilage
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Microfracture
CartiFill
Sponsored by
About this trial
This is an interventional treatment trial for Defect of Articular Cartilage focused on measuring cartilage defect in ankle, microfracture, modified microfracture using collagen, collagen
Eligibility Criteria
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.)
Sites / Locations
- Soon Chun Hyang University Hospital BucheonRecruiting
- Eulji general HospitalRecruiting
- Hallym University Medical Center-Kangnam Sacred Heart HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
modified microfracture using collagen
microfracture
Arm Description
modified microfracture using collagen (CartiFill) for cartilage defect of ankle
simple microfracture for cartilage defect of ankle
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02519881
First Posted
August 6, 2015
Last Updated
August 10, 2015
Sponsor
Sewon Cellontech Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02519881
Brief Title
the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Ankle
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 Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sewon Cellontech Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Defect of Articular Cartilage
Keywords
cartilage defect in ankle, microfracture, modified microfracture using collagen, collagen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
modified microfracture using collagen
Arm Type
Experimental
Arm Description
modified microfracture using collagen (CartiFill) for cartilage defect of ankle
Arm Title
microfracture
Arm Type
Active Comparator
Arm Description
simple microfracture for cartilage defect of ankle
Intervention Type
Procedure
Intervention Name(s)
Microfracture
Intervention Description
simple microfracture of ankle
Intervention Type
Device
Intervention Name(s)
CartiFill
Intervention Description
add collagen when doing microfracture
Primary Outcome Measure Information:
Title
100mmVAS(visual analogue scale) score
Description
The VAS's were evaluated 12 months after the surgery on the affected ankle in the study and control groups.
Time Frame
12 months after the surgery
Secondary Outcome Measure Information:
Title
Change score of 100mmVAS(visual analogue scale)
Description
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.
Time Frame
Screening, 6, 12, and 24months after surgery
Title
Change of Satisfaction evaluation by patients
Description
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.
Time Frame
Screening, 6, 12, and 24months after surgery
Title
Change of AOFAS(American orthopaedic foot & ankle society) Score
Description
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.
Time Frame
Screening, 6, 12, and 24months after surgery
Title
Change of Hannover Score
Description
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.
Time Frame
Screening, 6, 12, and 24months after surgery
Title
Change of Satisfaction evaluation by physician in charge
Description
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.
Time Frame
Screening, 6, 12, and 24months after surgery
Title
Change results of Arthroscopy (ICRS(International Cartilage Repair Society))
Description
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.
Time Frame
before and 24 months after the surgery
Title
the result of MRI(mMOCART)
Description
The conditions of the affected ankle 24 months after the surgery were recorded and the mMOCART were evaluated in the study and control group.
Time Frame
24 months after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Jo Kim, Bachelor
Phone
82-2-460-3237
Email
angel@swcell.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Soo Kim, MD
Organizational Affiliation
Eulji General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Young Hwan Kim, MD
Organizational Affiliation
Soon Chun Hyang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hyung Nyun Kim, MD
Organizational Affiliation
Hallym University Medical Center-Kangnam Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon
State/Province
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Hwan Kim, MD
Facility Name
Eulji general Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Soo Kim, MD
Facility Name
Hallym University Medical Center-Kangnam Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyung Nyun Kim, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
33143647
Citation
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.
Results Reference
derived
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the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Ankle
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