Comparison of Efficacy and Safety of Microfracture and Modified Microfracture

Phase 4

• Conditions: Traumatic Arthritis; Defect of Articular Cartilage; Osteoarthritis
• Interventions: Procedure: Microfracture; Device: CartiFill

• Registration Number: NCT02539030
• Lead Sponsor: 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 to prove the non-inferiority of the modified microfracture using collagen in patients with cartilage defects in their knees.

Detailed 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.)

Study Timeline

• Study Start: 2013-02
• Status Verified: 2015-08
• Study First Submitted: 2015-08-28
• Study First Submitted QC: 2015-08-31
• Last Update Submitted: 2015-08-31
• Study First Posted: 2015-09-02
• Last Update Posted: 2015-09-02
• Primary Completion: 2016-01
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

  3. 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).

  4. 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).

  5. Subjects under adrenocorticoid therapy (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).

  6. Subjects with psychiatric disorders who are considered inappropriate to participate in this trial by the Principal Investigator.

  7. 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
microfracture	Microfracture	simple microfracture for cartilage defect of knee
modified microfracture using collagen	Microfracture	modified microfracture using collagen (CartiFill) for cartilage defect of knee
modified microfracture using collagen	CartiFill	modified microfracture using collagen (CartiFill) for cartilage defect of knee

Primary Outcome Measures

Name	Time	Method
100mmVAS(Visual Analogue Scale)	12 month after surgery	It will be evaluated by the VAS score 12 months after surgery of the affected knee of the investigational group and the control group.

Secondary Outcome Measures

Name	Time	Method
change of 100 mmVAS (Visual Analogue Scale)	screening, 3, 6, 12 and 24 months after surgery	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.
change of Knee injury and osteoarthritis outcome (KOOS)	screening, 6, 12 and 24 months after surgery	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.
change of International Knee Documentation Committee (IKDC)	screening, 6, 12 and 24 months after surgery	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.
the results of MRI and MRI of articular cartilage examination (T2, T2 star, deGEMRIC, UTE, etc.), mMOCART	12 months after surgery	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.

Trial Locations

Locations (12)

The Catholic University of Korea Bucheon St. Mary's Hospital; 🇰🇷 Bucheon, Gyeonggi, Korea, Republic of

The Catholic University of Korea Vincent's Hospital; 🇰🇷 Suwon, Gyeonggi, Korea, Republic of

Wonkwang University Hospital; 🇰🇷 Iksan, Jeollabuk-do, Korea, Republic of

Daejeon Sun hospital; 🇰🇷 Daejeon, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Ewha Womans University Mokdong 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

Inje University Seoul Paik Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea St. Paul's Hospital; 🇰🇷 Seoul, Korea, Republic of