Clinical trial NCT02539030: Comparison of Efficacy and Safety of Microfracture and Modified Microfracture
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Defect of Articular Cartilage
Osteoarthritis
Traumatic Arthritis
Keywords: Cartilage defect of knee
microfracture
modified microfracture
collagen
Lead sponsor: Sewon Cellontech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-09-02
Enrollment: 100
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.)

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.)

Primary outcomes:
measure: 100mmVAS(Visual Analogue Scale)
timeFrame: 12 month after surgery
Secondary outcomes:
measure: change of 100 mmVAS (Visual Analogue Scale)
timeFrame: screening, 3, 6, 12 and 24 months after surgery
measure: change of Knee injury and osteoarthritis outcome (KOOS)
timeFrame: screening, 6, 12 and 24 months after surgery
measure: change of International Knee Documentation Committee (IKDC)
timeFrame: screening, 6, 12 and 24 months after surgery
measure: the results of MRI and MRI of articular cartilage examination (T2, T2 star, deGEMRIC, UTE, etc.), mMOCART
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea Bucheon St. Mary's Hospital
state: Gyeonggi
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea Vincent's Hospital
state: Gyeonggi
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
state: Jeollabuk-do
city: Daejeon
country: Korea, Republic of
facility: Daejeon Sun hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea St. Paul's Hospital
Study officials:
affiliation: Catholic University of Korea Saint Paul's Hospital
name: Nam Yong Choi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea
name: Yong In, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea Bucheon St.Mary's Hospital
name: Chan Woong Moon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea Vincent's Hospital
name: Hae Seock Ko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wonkwang University Hospital
name: Cheol Hong Jeon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SMG-SNU Boramae Medical Center
name: Seung Back Kang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Ja Young Choi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital
name: Myung Koo Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Daejeon Sun hospital
name: Jae Kyun Jun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ewha Womans University Mokdong Hospital
name: Jae Doo Yoo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Jung Koo Ha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Jun Ho Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: