The primary objective of this study is to confirm the superiority of intra-articular collagen injection in patients with knee joint pain compared to the control group. 100mm VAS is used to measure the pain of the subjects 24 weeks after the procedure.
This study is a double-blind clinical trial. Two hundred subjects has participated in it. The study is explained to the subjects, and they voluntarily choose to participate in it. Their eligibility to participate in the study is checked, and they are randomized either into the intra-articular collagen injection group or the normal saline (placebo) injection group based on a randomization table. They are asked to follow the guidelines of the investigators during the study and to visit the hospital five times, including for screening. At each visit, the subjects will undergo an examination with doctors, a medical examination by interview, and a blood test only when it is necessary to evaluate the safety and efficacy of the injection. (\*If the subjects performed the screening during the first visit on, the total number of his or her additional visits is four.)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity.
1. Supplementation of fluid and electrolytes (sodium or chlorine deficiency) 2. Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity.
Chung-Ang University Hospital
Seoul, Seoul, South Korea
Kunkuk University Medical Center
Seoul, Seoul, South Korea
Samsung Medical Center
Seoul, Seoul, South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, Seoul, South Korea
Score change of 100 mm VAS
The difference of the score of the investigational group and the control group at baseline and 24 weeks after injection will be calculated and analyzed
Time frame: 24 weeks after injection
Score change of WOMAC (Western Ontario and McMaster Universities)
The difference of the value of the affected knee of the investigational group and the control group at baseline, 4 weeks, 12 weeks, and 24 weeks after injection will be calculated and analyzed
Time frame: at the screening visit and then 4, 12, and 24 weeks after injection
Score change of SF-36 (36-ltem Short-Form Health Survey)
The difference of the value of the affected knee of the investigational group and the control group at baseline, 4 weeks, 12 weeks, and 24 weeks after injection will be calculated and analyzed
Time frame: at the screening visit and then 4, 12, and 24 weeks after injection
Score change of Satisfaction evaluation by patients
The improvement level of the investigational group and the control group will be evaluated by patients at the completion of clinical trial according to the 5 grade evaluation table. The difference of the improvement level (excellent+good+ moderate/total) of the two groups obtained at the completion of clinical trial will be compared and analyzed by z-test. In addition, the improvement level at each time point will be compared and analyzed.
Time frame: at 4, 12, and 24 weeks after injection
Score change of Satisfaction evaluation by physician in charge
The improvement level of the investigational group and the control group will be evaluated by clinicians at the completion of clinical trial according to the 5 grade evaluation table. The difference of the improvement level (excellent+good+ moderate/total) of the two groups obtained at the completion of clinical trial will be compared and analyzed by z-test. In addition, the improvement level at each time point will be compared and analyzed.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Catholic University of Yeouido St. Mary's Hospital
Seoul, Seoul, South Korea
Time frame: at 4, 12, and 24 weeks after injection
Score change of Physical examination
The difference of the score of the affected knee of the investigational group and the control group at the times prior to injection, 4 weeks, 12 weeks and 24 weeks after injection will be calculated and analyzed
Time frame: at the screening visit and then 4, 12, and 24 weeks after injection
Score change of 100 mm VAS
The difference of the score of the investigational group and the control group at before injection, 4 weeks and 12 weeks after injection will be calculated and analyzed
Time frame: at the screening visit and then 4 and 12weeks after injection