Comparison of Efficacy and Safety of Microfracture and Modified Microfracture

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

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis; Defect of Articular Cartilage; Traumatic Arthritis
• Intervention / Treatment: Device: CartiFill; Procedure: Microfracture

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: microfracture; simple microfracture for cartilage defect of knee	Procedure: Microfracture; simple microfracture
Experimental: modified microfracture using collagen; modified microfracture using collagen (CartiFill) for cartilage defect of knee	Device: CartiFill; add collagen when doing microfracture; Procedure: Microfracture; simple microfracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Sewon Cellontech Co., Ltd.
• Investigators: Principal Investigator: Yong In, MD, The Catholic University of Korea; Principal Investigator: Nam Yong Choi, MD, Catholic University of Korea Saint Paul's Hospital; 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: Jung Koo Ha, MD, Inje University; Principal Investigator: Jun Ho Wang, MD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: August 28, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Estimate): September 2, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: collagen; microfracture; Cartilage defect of knee; modified microfracture
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Stress
• Other Study ID Numbers: 03CAR