Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02519881
Other study ID # 04CAR
Secondary ID
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 CartiFillâ„¢ 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


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
See also
  Status Clinical Trial Phase
Completed NCT01473199 - BioPoly RS Knee Registry Study for Cartilage Defect Replacement N/A
Active, not recruiting NCT01670617 - DeNovo NT Natural Tissue Graft Stratified Knee Study N/A
Active, not recruiting NCT01347892 - DeNovo NT Ankle LDC Study N/A
Completed NCT02203071 - Comparison of BioCartilage Versus Marrow Stimulating Procedure for Cartilage Defects of the Knee
Completed NCT01626677 - Follow-Up Study of CARTISTEM® Versus Microfracture for the Treatment of Knee Articular Cartilage Injury or Defect Phase 3
Active, not recruiting NCT02855073 - Clinical Trial to Compare ReJoinTM to Sodium Hyaluronate Injection for Knee Osteoarthritis Cartilage Defects Phase 2
Terminated NCT01400607 - Neocartilage Implant to Treat Cartilage Lesions of the Knee Phase 3
Completed NCT01290991 - A Study to Evaluate the Safety of Augmentâ„¢ Bone Graft N/A
Terminated NCT00881023 - Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration N/A
Terminated NCT02542566 - Protected Versus Early Weight Bearing Post Microfracture Surgery N/A
Completed NCT02696876 - Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair N/A
Active, not recruiting NCT02524509 - the Safety and Efficacy Evaluation of Chondron Compared With Mircrofracture of Knee Phase 4
Active, not recruiting NCT02537067 - Efficacy and Safety of Chondron (Autologus Chondrocyte) in Patients With Cartilage Defects in Their Ankle Phase 3
Active, not recruiting NCT02539030 - Comparison of Efficacy and Safety of Microfracture and Modified Microfracture Phase 4
Active, not recruiting NCT02659215 - HyaloFAST Trial for Repair of Articular Cartilage in the Knee N/A
Terminated NCT01410136 - Chondrofix Osteochondral Allograft Prospective Study N/A
Active, not recruiting NCT00885729 - Mesenchymal Stem Cells in a Clinical Trial to Heal Articular Cartilage Defects Phase 1
Terminated NCT01246635 - Smith & Nephew's European Trufit Study N/A