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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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ClinicalTrials.gov Identifier: NCT02519881
Recruitment Status : Unknown
Verified August 2015 by Sewon Cellontech Co., Ltd..
Recruitment status was:  Recruiting
First Posted : August 11, 2015
Last Update Posted : August 11, 2015
Sponsor:
Information provided by (Responsible Party):
Sewon Cellontech Co., Ltd.

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.)

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

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




Primary Outcome Measures :
  1. 100mmVAS(visual analogue scale) score [ Time Frame: 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 :
  1. Change score of 100mmVAS(visual analogue scale) [ Time Frame: 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.

  2. Change of Satisfaction evaluation by patients [ Time Frame: 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.

  3. Change of AOFAS(American orthopaedic foot & ankle society) Score [ Time Frame: 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.

  4. Change of Hannover Score [ Time Frame: 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.

  5. Change of Satisfaction evaluation by physician in charge [ Time Frame: 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.

  6. Change results of Arthroscopy (ICRS(International Cartilage Repair Society)) [ Time Frame: 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.


  7. the result of MRI(mMOCART) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519881


Contacts
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Contact: Hyun Jo Kim, Bachelor 82-2-460-3237 angel@swcell.com

Locations
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Korea, Republic of
Soon Chun Hyang University Hospital Bucheon Recruiting
Bucheon, Gyeonggi-do, Korea, Republic of
Principal Investigator: Young Hwan Kim, MD         
Eulji general Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Jin Soo Kim, MD         
Hallym University Medical Center-Kangnam Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Hyung Nyun Kim, MD         
Sponsors and Collaborators
Sewon Cellontech Co., Ltd.
Investigators
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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

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Responsible Party: Sewon Cellontech Co., Ltd.
ClinicalTrials.gov Identifier: NCT02519881     History of Changes
Other Study ID Numbers: 04CAR
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015

Keywords provided by Sewon Cellontech Co., Ltd.:
cartilage defect in ankle
microfracture
modified microfracture using collagen
collagen

Additional relevant MeSH terms:
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Fractures, Stress
Cartilage Diseases
Fractures, Bone
Wounds and Injuries
Musculoskeletal Diseases
Connective Tissue Diseases