Comparison of Efficacy and Safety of Microfracture and Modified Microfracture

NCT ID: NCT02539030

Last Updated: 2015-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-06-30

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.)

Conditions

Defect of Articular Cartilage; Osteoarthritis; Traumatic Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

microfracture

simple microfracture for cartilage defect of knee

Group Type: ACTIVE_COMPARATOR

Microfracture

Intervention Type: PROCEDURE

simple microfracture

modified microfracture using collagen

modified microfracture using collagen (CartiFill) for cartilage defect of knee

Group Type: EXPERIMENTAL

Microfracture

Intervention Type: PROCEDURE

simple microfracture

CartiFill

Intervention Type: DEVICE

add collagen when doing microfracture

Interventions

Microfracture

simple microfracture

Intervention Type: PROCEDURE

CartiFill

add collagen when doing microfracture

Intervention Type: DEVICE

Eligibility Criteria

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.)

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sewon Cellontech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nam Yong Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Catholic University of Korea Saint Paul's Hospital

Yong In, MD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Chan Woong Moon, MD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea Bucheon St.Mary's Hospital

Hae Seock Ko, MD

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea Vincent's Hospital

Cheol Hong Jeon, MD

Role: PRINCIPAL_INVESTIGATOR

Wonkwang University Hospital

Seung Back Kang, MD

Role: PRINCIPAL_INVESTIGATOR

SMG-SNU Boramae Medical Center

Ja Young Choi, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Myung Koo Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Inha University Hospital

Jae Kyun Jun, MD

Role: PRINCIPAL_INVESTIGATOR

Daejeon Sun hospital

Jae Doo Yoo, MD

Role: PRINCIPAL_INVESTIGATOR

Ewha Womans University Mokdong Hospital

Jung Koo Ha, MD

Role: PRINCIPAL_INVESTIGATOR

Inje University

Jun Ho Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Daejeon Sun hospital

Daejeon, Daejeon, South Korea

The Catholic University of Korea Bucheon St. Mary's Hospital

Bucheon-si, Gyeonggi-do, South Korea

The Catholic University of Korea Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

Inha University Hospital

Incheon, Incheon, South Korea

Wonkwang University Hospital

Iksan, Jeollabuk-do, South Korea

Ewha Womans University Mokdong Hospital

Seoul, Seoul, South Korea

Inje University Seoul Paik Hospital

Seoul, Seoul, South Korea

Samsung Medical Center

Seoul, Seoul, South Korea

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, Seoul, South Korea

Seoul National University Hospital

Seoul, Seoul, South Korea

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, Seoul, South Korea

The Catholic University of Korea St. Paul's Hospital

Seoul, Seoul, South Korea

Countries

South Korea

References

Kim MS, Chun CH, Wang JH, Kang SB, Chang MJ, In Y. Microfracture Versus a Porcine-Derived Collagen-Augmented Chondrogenesis Technique for Treating Knee Cartilage Defects: Results at Midterm Follow-up. Orthop J Sports Med. 2024 Nov 7;12(11):23259671241292093. doi: 10.1177/23259671241292093. eCollection 2024 Nov.

Reference Type: DERIVED

PMID: 39525351 (View on PubMed)

Other Identifiers

03CAR

Identifier Type: -

Identifier Source: org_study_id