Comparison of Efficacy and Safety of Microfracture and Modified Microfracture

NCT02539030 | Unknown Phase 4 DMC

• 1 other identifier: 03CAR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 12

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.

Conditions

Defect of Articular Cartilage; Osteoarthritis; Traumatic Arthritis

Keywords

Cartilage defect of knee; microfracture; modified microfracture; collagen

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• change of 100 mmVAS (Visual Analogue Scale)

  screening, 3, 6, 12 and 24 months after surgery

• change of Knee injury and osteoarthritis outcome (KOOS)

  screening, 6, 12 and 24 months after surgery

• change of International Knee Documentation Committee (IKDC)

  screening, 6, 12 and 24 months after surgery

• the results of MRI and MRI of articular cartilage examination (T2, T2 star, deGEMRIC, UTE, etc.), mMOCART

  12 months after surgery

Study Arms (2)

microfracture

ACTIVE COMPARATOR

simple microfracture for cartilage defect of knee

Procedure: Microfracture

modified microfracture using collagen

EXPERIMENTAL

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

Procedure: Microfracture; Device: CartiFill

Interventions

Microfracture PROCEDURE

simple microfracture

microfracture; modified microfracture using collagen

CartiFill DEVICE

add collagen when doing microfracture

modified microfracture using collagen

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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).
• \. 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

You may not qualify if:

• \. If patients or their families suffer from or have ever suffered from an autoimmune disease.
• \. 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.
• \. 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).
• \. 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).
• \. Subjects under adrenocorticoid therapy (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
• \. Subjects with psychiatric disorders who are considered inappropriate to participate in this trial by the Principal Investigator.
• \. 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.)

Sponsors & Collaborators

• Sewon Cellontech Co., Ltd.: lead

Study Sites (12)

Daejeon Sun hospital

Daejeon, Daejeon, South Korea

Location

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

Bucheon-si, Gyeonggi-do, South Korea

Location

The Catholic University of Korea Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

Location

Inha University Hospital

Incheon, Incheon, South Korea

Location

Wonkwang University Hospital

Iksan, Jeollabuk-do, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, Seoul, South Korea

Location

Inje University Seoul Paik Hospital

Seoul, Seoul, South Korea

Location

Samsung Medical Center

Seoul, Seoul, South Korea

Location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, Seoul, South Korea

Location

Seoul National University Hospital

Seoul, Seoul, South Korea

Location

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

Seoul, Seoul, South Korea

Location

The Catholic University of Korea St. Paul's Hospital

Seoul, Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 39525351 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Fractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Nam Yong Choi, MD

  Catholic University of Korea Saint Paul's Hospital

  PRINCIPAL INVESTIGATOR

• Yong In, MD

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

• Chan Woong Moon, MD

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

  PRINCIPAL INVESTIGATOR

• Hae Seock Ko, MD

  The Catholic University of Korea Vincent's Hospital

  PRINCIPAL INVESTIGATOR

• Cheol Hong Jeon, MD

  Wonkwang University Hospital

  PRINCIPAL INVESTIGATOR

• Seung Back Kang, MD

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

• Ja Young Choi, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Myung Koo Kim, MD

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

• Jae Kyun Jun, MD

  Daejeon Sun hospital

  PRINCIPAL INVESTIGATOR

• Jae Doo Yoo, MD

  Ewha Womans University Mokdong Hospital

  PRINCIPAL INVESTIGATOR

• Jung Koo Ha, MD

  Inje University

  PRINCIPAL INVESTIGATOR

• Jun Ho Wang, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 2, 2015
• Study Start: February 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2017
• Last Updated: September 2, 2015

Record last verified: 2015-08

Locations

KR (12)