Comparison of Efficacy and Safety of Microfracture and Modified Microfracture

Osteoarthritis Clinical Trial

Official title:

Random Clinical Trial for Comparison of Efficacy and Safety of Simple Microfracture and Modified Microfracture Using Collagen in the Patients With Knee Cartilage Defects

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02539030
• Other study ID #: 03CAR
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 28, 2015
• Last updated: August 31, 2015
• Start date: February 2013
• Est. completion date: June 2017

Study information

• Verified date: August 2015
• Source: Sewon Cellontech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• 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 to prove the non-inferiority of the modified microfracture using collagen in patients with cartilage defects in their knees.

Description:

This study was an open-trial study. One hundred 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 centrally controlled randomization table. They were asked to follow the guidelines of the investigators during the study and to visit the hospital six times*, including for screening. At each visit, the subjects underwent an examination with doctors, a blood test, an X-ray procedure, an MRI, an observation with the naked eyes, and arthroscopy to evaluate the safety and efficacy of the procedure. (*If the screening date overlaps with the procedure date, the number of his or her visits would be five.)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• 1. Patients with cartilage defects in their knee (Including Knee OA and Knee TA) 2. Knee osteoarthritis patients whose Kellgren-Lawrence Grading Scale score is lower than 3 (patients who received simultaneous or previous correction will be excluded).

3. Patients with misalignment of their tibia and femur, unstable ligament in their knee, or bony defects in the lesions of their knee, and/or who had been treated for alignment 4. Patients who were 15 years old or older 5. 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
• Osteoarthritis
• Traumatic Arthritis

Intervention

Procedure:
• Microfracture
simple microfracture

Device:
• CartiFill
add collagen when doing microfracture

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea Bucheon St. Mary's Hospital	Bucheon	Gyeonggi
Korea, Republic of	Daejeon Sun hospital	Daejeon
Korea, Republic of	Wonkwang University Hospital	Iksan	Jeollabuk-do
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Inje University Seoul Paik Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Seoul St. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea St. Paul's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea Vincent's Hospital	Suwon	Gyeonggi

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)	It will be evaluated by the VAS score 12 months after surgery of the affected knee of the investigational group and the control group.	12 month after surgery	No
Secondary	change of 100 mmVAS (Visual Analogue Scale)	The difference between the VAS scores of the affected knee at the screening and 12 months after surgery in the investigational group will be compared to that in the control group. The differences in the VAS scores obtained at the follow-ups (3, 6, and 24 months after surgery) will be compared.	screening, 3, 6, 12 and 24 months after surgery	No
Secondary	change of Knee injury and osteoarthritis outcome (KOOS)	The difference between the KOOS scores of the affected knee at the screening and 12 months after surgery in the investigational group will be compared to that in the control group. The differences in the KOOS scores obtained at the follow-ups (6 and 24 months after surgery) will be compared.	screening, 6, 12 and 24 months after surgery	No
Secondary	change of International Knee Documentation Committee (IKDC)	The difference between the IKDC scores of the affected knee at the screening and 12 months after the surgery in the investigation group will be compared to that in the control group. The differences in the IKDC scores obtained at the follow-ups (6 and 24 months after surgery) will be compared.	screening, 6, 12 and 24 months after surgery	No
Secondary	the results of MRI and MRI of articular cartilage examination (T2, T2 star, deGEMRIC, UTE, etc.), mMOCART	The results obtained 12 months after the surgery on the affected knee in the investigational and control groups will be described. mMOCART will be obtained, and the difference will be assessed.; * Depending on the MRI equipment, if in-house imaging is not possible, it may be done at the other hospitals conducting the research.	12 months after surgery	No